HypoxiaNCT01866657
Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery
A study testing Vasoconstrictor Agents, Head/neck repositioning and Increase ETCO2 in people with Hypoxia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly patients undergoing thoracic surgical procedures that require the use of single lung ventilation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- Vasoconstrictor Agents, Head/neck repositioning and Increase ETCO2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 10 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Any male or female patient ≥ 65 years of age and able to provide informed consent (or consent may be provided by a legally authorized representative) who is scheduled for a thoracic surgical procedure that is expected to involve the use of intraoperative single lung ventilation (SLV)
- Able to adequately complete a baseline mini-mental status examination (MMSE)
- Able to complete a baseline confusion assessment method (CAM) examination
- Able to obtain bi-frontal baseline rSO2 values prior to induction of anesthesia
Who cannot join
- Any patient who has participated in a clinical study of an investigational drug or device in the past 30 days
- Any patient who the principal investigator feels at any time or for any reason should not participate in this clinical study
- Withdrawal of informed consent for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44126
About this study
Official title: NIRS-Based Cerebral Oximetry Monitoring in Elderly Thoracic Surgical Patients Undergoing Single Lung Ventilation Procedures: A Single Center, Prospective, Randomized Controlled Pilot Study Assessing the Clinical Impact of NIRS-Guided Intervention
This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly patients undergoing thoracic surgical procedures that require the use of single lung ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring that have active intervention to mitigate observed desaturations will have measurable postoperative clinical outcome benefits when compared to the patients randomized to blinded cerebral oximetry monitoring with no active interventions to mitigate desaturations.
Read the detailed description
Study Rationale The use of bi-frontal, near infrared spectrophotometry (NIRS) based cerebral oximetry monitoring has been demonstrated to result in improved clinical outcomes in both general surgery patients and cardiac surgical patients using prospective, randomized controlled trial methodology. Elderly thoracic surgical patients undergoing procedures that involve single lung ventilation may also stand to benefit from the application of intraoperative and early postoperative NIRS cerebral oximetry monitoring. Cerebral oximetry has not been established as a standard of care monitoring modality in this patient population, thus permitting the application of randomized, controlled testing methodology to assess the potential impact of this monitoring modality upon these patients.
Hypothesis and Objectives:
The primary hypothesis in this pilot study of elderly thoracic surgical patients undergoing procedures involving single lung ventilation (SLV) is that there will be a measurable and significant clinical benefit (as assessed by a broad range of postoperative clinical outcome measures) to the subjects randomized to the intervention cohort (open bi-frontal NIRS based cerebral oximetry monitoring with a standardized intervention protocol) vs. the control cohort (blinded bi-frontal NIRS based cerebral oximetry monitoring).
The primary objective of this pilot study is to identify the most relevant clinical outcome variables which significantly diverge as a result of being randomized to the intervention cohort vs. the control cohort so that a larger, multicenter, prospective, randomized controlled clinical trial can be designed to further test the primary hypothesis as stated in the preceding section. The subsequent larger, multicenter trial will be conducted to definitively demonstrate the ability of INVOS® 5100 guided NIRS-based bi-frontal monitoring to improve clinical outcomes in this surgical patient group and potentially establish a new U.S. Food and Drug Administration cleared indication for this monitoring modality. The clinical outcome variables being assessed as the primary objective are many and a detailed list of these variables can be found in the OUTCOME MEASURES - Primary Outcome Measure Section of this submission.
Secondary objectives of this pilot study include the following:
- Assess the frequency of cerebral desaturations in both the intervention and control cohorts by examining both the total number of patients experiencing any cerebral desaturation as well as the total number of events among patients experiencing any cerebral desaturation (of at least 5% below baseline and progressively larger desaturations). These analyses will be conducted on the entire study population as well as upon each cohort. The Area Under the Curve (AUC) analysis technique [incremental desaturation categories will be assessed based upon 5 to 50% decreases, measured in 5% increments, from established room air pre-incision baseline as well as oxygen supplemented pre-incision baseline as well as desaturations below absolute measured rSO2 values] will be employed to conduct these analyses.
- Assess the frequency of adverse clinical events and serious adverse events overall and in each cohort.
- Perform a comprehensive assessment of the frequency and efficacy of predefined rSO2 desaturation mitigation interventions and their collective ability to affect the observed cerebral oximetry values.
- Assess the interventional cohort's preoperative demographics and collected covariates for association with the ease or difficulty of mitigating observed cerebral desaturation events.
Exploratory analyses will include performing all possible comparisons of the two groups based upon all collected perioperative variables to examine the potentially significant relationships between the collected clinical variables representing surrogates of organ perfusion/function and cerebral oximetry desaturations (AUCrSO2). The following exploratory endpoints will be assessed:
- Logistic regression analysis to determine the most relevant AUCrSO2 desaturation value(s) associated with any detrimental clinical outcome(s) monitored in this study
- Logistic regression analysis to determine the most relevant AUC blood pressure values associated with any detrimental clinical outcome(s) monitored in this study
- Comparison of baseline rSO2 values (room air and oxygen supplemented) to all collected clinical variables to assess for possibly significant associations
- Explore the potential impact of rSO2 monitoring on changing the surgical conduct of the procedure Methodology: Single center, prospective, randomized, controlled clinical pilot study Number of Subjects: 100 subjects with balanced randomization (1:1) to control (blinded NIRS data) or intervention (open NIRS data) cohorts Main Criteria for Inclusion: Elderly patients (> 65 years of age) scheduled for a thoracic surgical procedure at UHCMC that will involve SLV.
Duration of Treatment: Cerebral oximetry monitoring will begin with an assessment of both room air and oxygen supplemented bi-frontal baseline NIRS values and continue through the surgery to either PACU discharge or the initial 12 hours of post surgical ICU treatment. Mini Mental Status exam testing and Delirium testing with the Confusion Assessment Method will occur preoperatively and postoperatively through post-operative day (POD) #3 (or discharge if that occurs sooner than POD #3). Enrolled subjects will be followed during the index hospitalization and will undergo a 30 day follow up telephone interview to assess their progress following hospital discharge.
Criteria for Evaluation:
A large number of intraoperative and postoperative clinical variables that include cerebral oximetry, pulse oximetry, blood pressure, a composite outcome measure and clinical variables representing organ function will be assessed with the primary endpoint being the determination of which clinical variables are improved, if any, as a result of being randomized to open NIRS data monitoring with a predefined desaturation intervention algorithm guideline. The Mini Mental Status exam and Confusion Assessment Method test will be used to determine if any measured clinical variables have an effect upon neuropsychological outcomes. The frequency and effectiveness of the various cerebral desaturation mitigating interventions will be assessed in the intervention cohort.
Additional Safety Observations:
The frequency and severity of adverse clinical events and serious adverse clinical events will be assessed to determine if the use of open NIRS data bi-frontal cerebral monitoring is associated with any significant change in the observation of such events.
Statistical Methods:
Preoperative demographics and clinical variables will be compared in the two groups to assess for significant differences using the independent t-test. Differences in the observed clinical data between groups will be determined with the Wilcoxon rank-sum test. Stepwise, forward, multivariable logistic regression analysis will be performed to assess for relationships between cerebral desaturations and any of the measured clinical variables with a p value < 0.05 being considered significant
- Conditions
- Hypoxia
- Being tested
- Vasoconstrictor Agents, Head/neck repositioning, Increase ETCO2, IV fluid bolus, Additional anesthesia
- Keywords
- cerebral oximetry, randomized controlled pilot study, thoracic surgery, single lung ventilation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasoconstrictor AgentsDrug
Also called phenylephrine, ephedrine, dopamine
cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion.
Head/neck repositioningOther
Also called neck repositioning
Assure that arterial and venous neck blood flow is not obstructed related to patient positioning
Increase ETCO2Other
Also called Normalize end tidal CO2
Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery
IV fluid bolusOther
Administer IV fluids to increase preload and cardiac output
Additional anesthesiaDrug
Also called sevoflurane, propofol
By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption.
RBC transfusionBiological
By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity
Increase FiO2Drug
Also called Increase fractional concentration of inspired oxygen
Increase FiO2 to improve oxygen delivery to tissue
| Study group | Role | What they receive |
|---|---|---|
| Intervention cohort | Experimental | Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion. Receives: Drug: Vasoconstrictor Agents; Other: Head/neck repositioning; Other: Increase ETCO2; Other: IV fluid bolus; Drug: Additional anesthesia; Biological: RBC transfusion; Drug: Increase FiO2 |
| Blinded cerebral oximetry monitoring | No intervention | These subjects will have continous cerebral oximetry monitoring like the experimental cohort but the values will be blinded to all clinicians and research staff. There will be no cerebral desaturation interventions in this group because the clinicians will not be aware of a desaturation as the monitor's output is blinded in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Objective of This Pilot Study is to Identify the Most Relevant Clinical Outcome Variables Which Significantly Diverge as a Result of Being Randomized to the Intervention Cohort vs. the Control Cohort.
The clinical endpoints are defined by the clinical outcome variables assessed and include relationship of assignment group and AUC of cerebral desats and their observed relationship to PACU/hospital/ICU LOS, AUC of mean arterial blood pressure, IV vasoactive drugs, intraop mLs urine/kg/hr in OR, red blood cell(RBC) transfusion, change in surgical procedure, intra/postop stroke/TIA/MI/afib/AUC glucose > 110 mg/dL, OR time, narcotic administered in the OR, volume of crystalloid/colloid administered in the OR, Anti-emetic meds administered in the OR, Surgical procedure performed, Time on single lung ventilation, Intraop Use of epidural catheter, aldrete PACU score, frequency/severity of N/V in the PACU/ICU, mech vent time in the PACU/ICU, need for postop skilled nursing facility/rehab hospital, need for hospital readmission, change in MMSE/CAM scores from baseline, change in renal fxn compared to baseline, return of bowel function time, postop infection, postop composite endpoint
Measured: One year
Relationship of Assignment Group to PACU Length of Stay.
Relationship of assignment group (i.e. control vs intervention group) to PACU LOS
Measured: One year
Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to PACU LOS
Relationship of AUC of cerebral desats to PACU LOS
Measured: One year
Relationship of Assignment Group to Hospital Length of Stay (HLOS)
Relationship of assignment group (i.e. control vs intervention group) to HLOS
Measured: One Year
Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to HLOS
Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS
Measured: One year
Relationship of Assignment Group to ICU LOS
Relationship of assignment group to ICU LOS
Measured: One year
Relationship of AUC Cerebral Desaturations to ICU LOS
Relationship of AUC cerebral desaturations to ICU LOS
Measured: One year
Relationship of Assignment Group to AUC of Mean Arterial Blood Pressure
Relationship of assignment group to AUC of mean arterial blood pressure
Measured: One Year
Relationship of AUC Cerebral Desaturations to AUC of Mean Arterial Blood Pressure
Relationship of AUC cerebral desaturations to AUC of mean arterial blood pressure
Measured: One Year
Relationship of Assignment Group to Observed Intraoperative mLs Urine/kg/hr
Relationship of assignment group to observed intraoperative mLs urine/kg/hr
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Intraoperative mLs Urine/kg/hr
Relationship of AUC cerebral desaturations to observed intraoperative mLs urine/kg/hr
Measured: One year
Relationship of Assignment Group to Transfusion of Red Blood Cells
Relationship of assignment group to transfusion of red blood cells
Measured: One year
Relationship of AUC Cerebral Desaturations to Transfusion of Red Blood Cells
Relationship of AUC cerebral desaturations to transfusion of red blood cells
Measured: One year
Relationship of Assignment Group to Observed Frequency of Any Change in Surgical Procedure
Relationship of assignment group to observed frequency of any change in surgical procedure
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Frequency of Any Change in Surgical Procedure
Relationship of AUC cerebral desaturations to observed frequency of any change in surgical procedure
Measured: One year
Relationship of Assignment Group to Observed Frequency of Intraoperative or Postoperative Stroke
Relationship of assignment group to observed frequency of intraoperative or postoperative stroke
Measured: One Year
Relationship of AUC Cerebral Desaturations to Observed Frequency of Intraoperative or Postoperative Stroke
Relationship of AUC cerebral desaturations to observed frequency of intraoperative or postoperative stroke
Measured: One year
Relationship of Assignment Group to Observed Frequency of Transient Ischemic Attack
Relationship of assignment group to observed frequency of transient ischemic attack
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Frequency of Transient Ischemic Attack
Relationship of AUC cerebral desaturations to observed frequency of transient ischemic attack
Measured: One year
Relationship of Assignment Group to Observed Frequency of Myocardial Infarction
Relationship of assignment group to observed frequency of myocardial infarction
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Frequency of Myocardial Infarction
Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction
Measured: One year
Relationship of Assignment Group to Observed Frequency of Atrial Fibrillation
Relationship of assignment group to observed frequency of atrial fibrillation
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Frequency of Atrial Fibrillation
Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation
Measured: One year
Relationship of Assignment Group to Observed Frequency of AUC Glucose > 110 mg/dL
Relationship of assignment group to observed frequency of AUC glucose > 110 mg/dL
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Frequency of AUC Glucose > 110 mg/dL
Relationship of AUC cerebral desaturations to observed frequency of AUC glucose > 110 mg/dL
Measured: One year
Relationship of Assignment Group to Observed Operating Room Time
Relationship of assignment group to observed operating room time
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Operating Room Time
Relationship of AUC cerebral desaturations to observed operating room time
Measured: One year
Relationship of Assignment Group to Observed Amount of Narcotic Administered in the Operating Room
Relationship of assignment group to observed amount of narcotic administered in the operating room
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Amount of Narcotic Administered in the Operating Room
Relationship of AUC cerebral desaturations to observed amount of narcotic administered in the operating room
Measured: One year
Relationship of Assignment Group to Observed Volume of Crystalloid/Colloid Administered in the Operating Room
Relationship of assignment group to observed volume of crystalloid/colloid administered in the operating room
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Volume of Crystalloid/Colloid Administered in the Operating Room
Relationship of AUC cerebral desaturations to observed volume of crystalloid/colloid administered in the operating room
Measured: One year
Relationship of Assignment Group to Observed Amount of Anti-emetic Meds Administered in the Operating Room
Relationship of assignment group to observed amount of anti-emetic meds administered in the operating room
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Amount of Anti-emetic Meds Administered in the Operating Room
Relationship of AUC cerebral desaturations to observed amount of anti-emetic meds administered in the operating room
Measured: One year
Relationship of Assignment Group to Reported Surgical Procedure Performed
Relationship of assignment group to reported surgical procedure performed
Measured: One year
Relationship of AUC Cerebral Desaturations to Reported Surgical Procedure Performed
Relationship of AUC cerebral desaturations to reported surgical procedure
Measured: One year
Relationship of Assignment Group to Observed Time on Single Lung Ventilation
Relationship of assignment group to observed time on single lung ventilation
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Time on Single Lung Ventilation
Relationship of AUC cerebral desaturations to observed time on single lung ventilation
Measured: One year
Relationship of Assignment Group to Observed Use of Epidural Catheter
Relationship of assignment group to observed use of epidural catheter
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Use of Epidural Catheter
Relationship of AUC cerebral desaturations to observed use of epidural catheter
Measured: One year
Relationship of Assignment Group to Observed Post Anesthesia Care Unit Aldrete Score
Relationship of assignment group to observed post anesthesia care unit Aldrete score
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Post Anesthesia Care Unit Aldrete Score
Relationship of AUC cerebral desaturations to observed post anesthesia care unit Aldrete score
Measured: One year
Relationship of Assignment Group to Observed Frequency and Severity of Nausea/Vomiting in the Post Anesthesia Care Unit/Intensive Care Unit
Relationship of assignment group to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Frequency and Severity of Nausea/Vomiting in the Post Anesthesia Care Unit/Intensive Care Unit
Relationship of AUC cerebral desaturations to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit
Measured: One year
Relationship of Assignment Group to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit
Relationship of assignment group to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit
Relationship of AUC cerebral desaturations to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit
Measured: One year
Relationship of Assignment Group to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility
Relationship of assignment group to observed need for postoperative discharge to skilled nursing/rehabilitation facility
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility
Relationship of AUC cerebral desaturations to observed need for postoperative discharge to skilled nursing/rehabilitation facility
Measured: One year
Relationship of Assignment Group to Observed Need for Hospital Readmission
Relationship of assignment group to observed need for hospital readmission
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Need for Hospital Readmission
Relationship of AUC cerebral desaturations to observed need for hospital readmission
Measured: One year
Relationship of Assignment Group to Observed Change in CAM or MMSE Scores From Baseline
Relationship of assignment group to observed change in CAM or MMSE scores from baseline
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Change in CAM or MMSE Scores From Baseline
Relationship of AUC cerebral desaturations to observed change in CAM or MMSE scores from baseline
Measured: One year
Relationship of Assignment Group to Observed Change in Renal Function From Baseline
Relationship of assignment group to observed change in renal function from baseline
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Change in Renal Function From Baseline
Relationship of AUC cerebral desaturations to observed change in renal function from baseline
Measured: One year
Relationship of Assignment Group to Observed Time to Return of Bowel Function Time
Relationship of assignment group to observed time to return of bowel function time
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Time to Return of Bowel Function Time
Relationship of AUC cerebral desaturations to observed time to return of bowel function time
Measured: One year
Relationship of Group Assignment to Any Observed Postoperative Infection
Relationship of group assignment to any observed postoperative infection
Measured: One year
Relationship of AUC Cerebral Desaturations to Any Observed Postoperative Infection
Relationship of AUC cerebral desaturations to any observed postoperative infection
Measured: One year
Relationship of Assignment Group to Observed Time to Wean From Postoperative Supplemental Oxygen
Relationship of assignment group to observed time to wean from postoperative supplemental oxygen
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Time to Wean From Postoperative Supplemental Oxygen
Relationship of AUC cerebral desaturations to observed time to wean from postoperative supplemental oxygen
Measured: One year
Relationship of Assignment Group to Observed Incidence of Postop Morbidity Composite Endpoint (Defined in Description Section Below)
Relationship of assignment group to observed incidence of postop morbidity composite endpoint (defined by having any 1 of the following: new onset afib, ≥Grade 2 PONV, HLOS≥4.5 days, PACU LOS≥2 hours, any infection, death, stroke, MI, greater 0.5 mg/dL increase in Cr or new need for renal dialysis, postop need for IV inotropes or vasoactive meds)
Measured: One year
Relationship of AUC Cerebral Desaturations to Observed Incidence of Postoperative Morbidity Composite Endpoint (Defined in Description Section Below)
Relationship of AUC cerebral desaturations to observed incidence of postoperative morbidity composite endpoint (defined by having any one of the following: new onset atrial fibrillation, ≥Grade 2 PONV, HLOS≥4.5 days, PACU LOS≥2 hours, any infectious complication, death, stroke, myocardial infarction, greater 0.5 mg/dL increase in creatinine or new need for renal dialysis, postoperative need for intravenous inotropes or vasoactive medications)
Measured: One year
Secondary outcomes (4)
Assess the Frequency of Cerebral Desaturations in Both Cohorts by Examining Both the Total Number of Patients Experiencing Any Cerebral Desaturation as Well as the Total Number of Events Among Patients Experiencing Any Cerebral Desaturation.
Assess the frequency of cerebral desaturations in both the intervention and control cohorts by examining both the total number of patients experiencing any cerebral desaturation as well as the total number of events among patients experiencing any cerebral desaturation.
Measured: one year
Adverse Clinical Events and Serious Adverse Events Overall and in Each Cohort
Assess the frequency of adverse clinical events and serious adverse events overall and in each cohort
Measured: one year
Perform a Comprehensive Assessment of the Frequency and Efficacy of Predefined rSO2 Desaturation Mitigation Interventions and Their Collective Ability to Affect the Observed Cerebral Oximetry Values.
Perform a comprehensive assessment of the frequency and efficacy of predefined rSO2 desaturation mitigation interventions (e.g., increase MAP with IV vasoconstrictor or fluid bolus, normalize ETCO2, deepen anesthesia, etc.) and their collective ability to affect the observed cerebral oximetry values. This will allow determination of the average number of interventions required and those most commonly effective in mitigating desaturation.
Measured: one year
Assess the Interventional Cohort's Preoperative Demographics and Collected Covariates for Association With the Ease or Difficulty of Mitigating Observed Cerebral Desaturation Events.
Because mitigating cerebral desaturations involves increasing oxygen delivery to the tissue it is possible that there is a relationship between preoperative demographic/variables such as age, peripheral vascular disease, left ventricular dysfunction, COPD, etc. and the ability to effectively mitigate desaturations in that subjects with disease in these organ systems may be more resistant to responding to desaturation interventions.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2013
- Primary completion10 Nov 2016
- Study completion10 Nov 2016
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C Klick, MD, Principal investigator, University Hospitals Cleveland Medical CenterEdwin G Avery, MD, Study director, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866657
- Sponsor's protocol ID
- UHCMC-CEROX-01
- Status last verified
- Jul 2022
- First submitted
- 12 May 2013
- Last updated
- 5 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Avery EG. Cerebral oximetry is frequently a "first alert" indicator of adverse outcomes. White paper. October 2010. http://www.somanetics.com/images/stories/pdfs/white-paper-series.pdf Last accessed 08-05-2012
Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.
PubMed 16115985Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
PubMed 17179242Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
PubMed 22311364
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS-Based Cerebral Oximetry Monitoring in Elderly Thoracic Surgical Patients Undergoing Single Lung Ventilation Procedures: A Single Center, Prospective, Randomized Controlled Pilot Study Assessing the Clinical Impact of NIRS-Guided Intervention
- ClinicalTrials.gov ID
- NCT01866657
- Acronym / sponsor ID
- UHCMC-CEROX-01
- Conditions
- Hypoxia
- Keywords
- cerebral oximetry, randomized controlled pilot study, thoracic surgery, single lung ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 10 Nov 2016 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Posted 5 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly patients undergoing thoracic surgical procedures that require the use of single lung ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring that have active intervention to mitigate observed desaturations will have measurable postoperative clinical outcome benefits when compared to the patients randomized to blinded cerebral oximetry monitoring with no active interventions to mitigate desaturations.
Detailed description
Study Rationale The use of bi-frontal, near infrared spectrophotometry (NIRS) based cerebral oximetry monitoring has been demonstrated to result in improved clinical outcomes in both general surgery patients and cardiac surgical patients using prospective, randomized controlled trial methodology. Elderly thoracic surgical patients undergoing procedures that involve single lung ventilation may also stand to benefit from the application of intraoperative and early postoperative NIRS cerebral oximetry monitoring. Cerebral oximetry has not been established as a standard of care monitoring modality in this patient population, thus permitting the application of randomized, controlled testing methodology to assess the potential impact of this monitoring modality upon these patients.
Hypothesis and Objectives:
The primary hypothesis in this pilot study of elderly thoracic surgical patients undergoing procedures involving single lung ventilation (SLV) is that there will be a measurable and significant clinical benefit (as assessed by a broad range of postoperative clinical outcome measures) to the subjects randomized to the intervention cohort (open bi-frontal NIRS based cerebral oximetry monitoring with a standardized intervention protocol) vs. the control cohort (blinded bi-frontal NIRS based cerebral oximetry monitoring).
The primary objective of this pilot study is to identify the most relevant clinical outcome variables which significantly diverge as a result of being randomized to the intervention cohort vs. the control cohort so that a larger, multicenter, prospective, randomized controlled clinical trial can be designed to further test the primary hypothesis as stated in the preceding section. The subsequent larger, multicenter trial will be conducted to definitively demonstrate the ability of INVOS® 5100 guided NIRS-based bi-frontal monitoring to improve clinical outcomes in this surgical patient group and potentially establish a new U.S. Food and Drug Administration cleared indication for this monitoring modality. The clinical outcome variables being assessed as the primary objective are many and a detailed list of these variables can be found in the OUTCOME MEASURES - Primary Outcome Measure Section of this submission.
Secondary objectives of this pilot study include the following:
- Assess the frequency of cerebral desaturations in both the intervention and control cohorts by examining both the total number of patients experiencing any cerebral desaturation as well as the total number of events among patients experiencing any cerebral desaturation (of at least 5% below baseline and progressively larger desaturations). These analyses will be conducted on the entire study population as well as upon each cohort. The Area Under the Curve (AUC) analysis technique [incremental desaturation categories will be assessed based upon 5 to 50% decreases, measured in 5% increments, from established room air pre-incision baseline as well as oxygen supplemented pre-incision baseline as well as desaturations below absolute measured rSO2 values] will be employed to conduct these analyses.
- Assess the frequency of adverse clinical events and serious adverse events overall and in each cohort.
- Perform a comprehensive assessment of the frequency and efficacy of predefined rSO2 desaturation mitigation interventions and their collective ability to affect the observed cerebral oximetry values.
- Assess the interventional cohort's preoperative demographics and collected covariates for association with the ease or difficulty of mitigating observed cerebral desaturation events.
Exploratory analyses will include performing all possible comparisons of the two groups based upon all collected perioperative variables to examine the potentially significant relationships between the collected clinical variables representing surrogates of organ perfusion/function and cerebral oximetry desaturations (AUCrSO2). The following exploratory endpoints will be assessed:
- Logistic regression analysis to determine the most relevant AUCrSO2 desaturation value(s) associated with any detrimental clinical outcome(s) monitored in this study
- Logistic regression analysis to determine the most relevant AUC blood pressure values associated with any detrimental clinical outcome(s) monitored in this study
- Comparison of baseline rSO2 values (room air and oxygen supplemented) to all collected clinical variables to assess for possibly significant associations
- Explore the potential impact of rSO2 monitoring on changing the surgical conduct of the procedure Methodology: Single center, prospective, randomized, controlled clinical pilot study Number of Subjects: 100 subjects with balanced randomization (1:1) to control (blinded NIRS data) or intervention (open NIRS data) cohorts Main Criteria for Inclusion: Elderly patients (> 65 years of age) scheduled for a thoracic surgical procedure at UHCMC that will involve SLV.
Duration of Treatment: Cerebral oximetry monitoring will begin with an assessment of both room air and oxygen supplemented bi-frontal baseline NIRS values and continue through the surgery to either PACU discharge or the initial 12 hours of post surgical ICU treatment. Mini Mental Status exam testing and Delirium testing with the Confusion Assessment Method will occur preoperatively and postoperatively through post-operative day (POD) #3 (or discharge if that occurs sooner than POD #3). Enrolled subjects will be followed during the index hospitalization and will undergo a 30 day follow up telephone interview to assess their progress following hospital discharge.
Criteria for Evaluation:
A large number of intraoperative and postoperative clinical variables that include cerebral oximetry, pulse oximetry, blood pressure, a composite outcome measure and clinical variables representing organ function will be assessed with the primary endpoint being the determination of which clinical variables are improved, if any, as a result of being randomized to open NIRS data monitoring with a predefined desaturation intervention algorithm guideline. The Mini Mental Status exam and Confusion Assessment Method test will be used to determine if any measured clinical variables have an effect upon neuropsychological outcomes. The frequency and effectiveness of the various cerebral desaturation mitigating interventions will be assessed in the intervention cohort.
Additional Safety Observations:
The frequency and severity of adverse clinical events and serious adverse clinical events will be assessed to determine if the use of open NIRS data bi-frontal cerebral monitoring is associated with any significant change in the observation of such events.
Statistical Methods:
Preoperative demographics and clinical variables will be compared in the two groups to assess for significant differences using the independent t-test. Differences in the observed clinical data between groups will be determined with the Wilcoxon rank-sum test. Stepwise, forward, multivariable logistic regression analysis will be performed to assess for relationships between cerebral desaturations and any of the measured clinical variables with a p value < 0.05 being considered significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | Experimental | Drug: Vasoconstrictor Agents, Other: Head/neck repositioning, Other: Increase ETCO2, Other: IV fluid bolus, Drug: Additional anesthesia, Biological: RBC transfusion, Drug: Increase FiO2Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion. |
| Blinded cerebral oximetry monitoring | No intervention | –These subjects will have continous cerebral oximetry monitoring like the experimental cohort but the values will be blinded to all clinicians and research staff. There will be no cerebral desaturation interventions in this group because the clinicians will not be aware of a desaturation as the monitor's output is blinded in this group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Any male or female patient ≥ 65 years of age and able to provide informed consent (or consent may be provided by a legally authorized representative) who is scheduled for a thoracic surgical procedure that is expected to involve the use of intraoperative single lung ventilation (SLV)
- Able to adequately complete a baseline mini-mental status examination (MMSE)
- Able to complete a baseline confusion assessment method (CAM) examination
- Able to obtain bi-frontal baseline rSO2 values prior to induction of anesthesia
Key exclusion criteria (3 listed)
- Any patient who has participated in a clinical study of an investigational drug or device in the past 30 days
- Any patient who the principal investigator feels at any time or for any reason should not participate in this clinical study
- Withdrawal of informed consent for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasoconstrictor AgentsAlso: phenylephrine, ephedrine, dopaminecerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion. | Drug | Intervention cohort |
| Head/neck repositioningAlso: neck repositioningAssure that arterial and venous neck blood flow is not obstructed related to patient positioning | Other | Intervention cohort |
| Increase ETCO2Also: Normalize end tidal CO2Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery | Other | Intervention cohort |
| IV fluid bolusAdminister IV fluids to increase preload and cardiac output | Other | Intervention cohort |
| Additional anesthesiaAlso: sevoflurane, propofolBy deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption. | Drug | Intervention cohort |
| RBC transfusionBy administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity | Biological | Intervention cohort |
| Increase FiO2Also: Increase fractional concentration of inspired oxygenIncrease FiO2 to improve oxygen delivery to tissue | Drug | Intervention cohort |
Primary outcome
The Primary Objective of This Pilot Study is to Identify the Most Relevant Clinical Outcome Variables Which Significantly Diverge as a Result of Being Randomized to the Intervention Cohort vs. the Control Cohort.
Time frame: One year
The clinical endpoints are defined by the clinical outcome variables assessed and include relationship of assignment group and AUC of cerebral desats and their observed relationship to PACU/hospital/ICU LOS, AUC of mean arterial blood pressure, IV vasoactive drugs, intraop mLs urine/kg/hr in OR, red blood cell(RBC) transfusion, change in surgical procedure, intra/postop stroke/TIA/MI/afib/AUC glucose > 110 mg/dL, OR time, narcotic administered in the OR, volume of crystalloid/colloid administered in the OR, Anti-emetic meds administered in the OR, Surgical procedure performed, Time on single lung ventilation, Intraop Use of epidural catheter, aldrete PACU score, frequency/severity of N/V in the PACU/ICU, mech vent time in the PACU/ICU, need for postop skilled nursing facility/rehab hospital, need for hospital readmission, change in MMSE/CAM scores from baseline, change in renal fxn compared to baseline, return of bowel function time, postop infection, postop composite endpoint
Relationship of Assignment Group to PACU Length of Stay.
Time frame: One year
Relationship of assignment group (i.e. control vs intervention group) to PACU LOS
Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to PACU LOS
Time frame: One year
Relationship of AUC of cerebral desats to PACU LOS
Relationship of Assignment Group to Hospital Length of Stay (HLOS)
Time frame: One Year
Relationship of assignment group (i.e. control vs intervention group) to HLOS
Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to HLOS
Time frame: One year
Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS
Relationship of Assignment Group to ICU LOS
Time frame: One year
Relationship of assignment group to ICU LOS
Relationship of AUC Cerebral Desaturations to ICU LOS
Time frame: One year
Relationship of AUC cerebral desaturations to ICU LOS
Relationship of Assignment Group to AUC of Mean Arterial Blood Pressure
Time frame: One Year
Relationship of assignment group to AUC of mean arterial blood pressure
Relationship of AUC Cerebral Desaturations to AUC of Mean Arterial Blood Pressure
Time frame: One Year
Relationship of AUC cerebral desaturations to AUC of mean arterial blood pressure
Relationship of Assignment Group to Observed Intraoperative mLs Urine/kg/hr
Time frame: One year
Relationship of assignment group to observed intraoperative mLs urine/kg/hr
Relationship of AUC Cerebral Desaturations to Observed Intraoperative mLs Urine/kg/hr
Time frame: One year
Relationship of AUC cerebral desaturations to observed intraoperative mLs urine/kg/hr
Relationship of Assignment Group to Transfusion of Red Blood Cells
Time frame: One year
Relationship of assignment group to transfusion of red blood cells
Relationship of AUC Cerebral Desaturations to Transfusion of Red Blood Cells
Time frame: One year
Relationship of AUC cerebral desaturations to transfusion of red blood cells
Relationship of Assignment Group to Observed Frequency of Any Change in Surgical Procedure
Time frame: One year
Relationship of assignment group to observed frequency of any change in surgical procedure
Relationship of AUC Cerebral Desaturations to Observed Frequency of Any Change in Surgical Procedure
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency of any change in surgical procedure
Relationship of Assignment Group to Observed Frequency of Intraoperative or Postoperative Stroke
Time frame: One Year
Relationship of assignment group to observed frequency of intraoperative or postoperative stroke
Relationship of AUC Cerebral Desaturations to Observed Frequency of Intraoperative or Postoperative Stroke
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency of intraoperative or postoperative stroke
Relationship of Assignment Group to Observed Frequency of Transient Ischemic Attack
Time frame: One year
Relationship of assignment group to observed frequency of transient ischemic attack
Relationship of AUC Cerebral Desaturations to Observed Frequency of Transient Ischemic Attack
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency of transient ischemic attack
Relationship of Assignment Group to Observed Frequency of Myocardial Infarction
Time frame: One year
Relationship of assignment group to observed frequency of myocardial infarction
Relationship of AUC Cerebral Desaturations to Observed Frequency of Myocardial Infarction
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction
Relationship of Assignment Group to Observed Frequency of Atrial Fibrillation
Time frame: One year
Relationship of assignment group to observed frequency of atrial fibrillation
Relationship of AUC Cerebral Desaturations to Observed Frequency of Atrial Fibrillation
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation
Relationship of Assignment Group to Observed Frequency of AUC Glucose > 110 mg/dL
Time frame: One year
Relationship of assignment group to observed frequency of AUC glucose > 110 mg/dL
Relationship of AUC Cerebral Desaturations to Observed Frequency of AUC Glucose > 110 mg/dL
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency of AUC glucose > 110 mg/dL
Relationship of Assignment Group to Observed Operating Room Time
Time frame: One year
Relationship of assignment group to observed operating room time
Relationship of AUC Cerebral Desaturations to Observed Operating Room Time
Time frame: One year
Relationship of AUC cerebral desaturations to observed operating room time
Relationship of Assignment Group to Observed Amount of Narcotic Administered in the Operating Room
Time frame: One year
Relationship of assignment group to observed amount of narcotic administered in the operating room
Relationship of AUC Cerebral Desaturations to Observed Amount of Narcotic Administered in the Operating Room
Time frame: One year
Relationship of AUC cerebral desaturations to observed amount of narcotic administered in the operating room
Relationship of Assignment Group to Observed Volume of Crystalloid/Colloid Administered in the Operating Room
Time frame: One year
Relationship of assignment group to observed volume of crystalloid/colloid administered in the operating room
Relationship of AUC Cerebral Desaturations to Observed Volume of Crystalloid/Colloid Administered in the Operating Room
Time frame: One year
Relationship of AUC cerebral desaturations to observed volume of crystalloid/colloid administered in the operating room
Relationship of Assignment Group to Observed Amount of Anti-emetic Meds Administered in the Operating Room
Time frame: One year
Relationship of assignment group to observed amount of anti-emetic meds administered in the operating room
Relationship of AUC Cerebral Desaturations to Observed Amount of Anti-emetic Meds Administered in the Operating Room
Time frame: One year
Relationship of AUC cerebral desaturations to observed amount of anti-emetic meds administered in the operating room
Relationship of Assignment Group to Reported Surgical Procedure Performed
Time frame: One year
Relationship of assignment group to reported surgical procedure performed
Relationship of AUC Cerebral Desaturations to Reported Surgical Procedure Performed
Time frame: One year
Relationship of AUC cerebral desaturations to reported surgical procedure
Relationship of Assignment Group to Observed Time on Single Lung Ventilation
Time frame: One year
Relationship of assignment group to observed time on single lung ventilation
Relationship of AUC Cerebral Desaturations to Observed Time on Single Lung Ventilation
Time frame: One year
Relationship of AUC cerebral desaturations to observed time on single lung ventilation
Relationship of Assignment Group to Observed Use of Epidural Catheter
Time frame: One year
Relationship of assignment group to observed use of epidural catheter
Relationship of AUC Cerebral Desaturations to Observed Use of Epidural Catheter
Time frame: One year
Relationship of AUC cerebral desaturations to observed use of epidural catheter
Relationship of Assignment Group to Observed Post Anesthesia Care Unit Aldrete Score
Time frame: One year
Relationship of assignment group to observed post anesthesia care unit Aldrete score
Relationship of AUC Cerebral Desaturations to Observed Post Anesthesia Care Unit Aldrete Score
Time frame: One year
Relationship of AUC cerebral desaturations to observed post anesthesia care unit Aldrete score
Relationship of Assignment Group to Observed Frequency and Severity of Nausea/Vomiting in the Post Anesthesia Care Unit/Intensive Care Unit
Time frame: One year
Relationship of assignment group to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit
Relationship of AUC Cerebral Desaturations to Observed Frequency and Severity of Nausea/Vomiting in the Post Anesthesia Care Unit/Intensive Care Unit
Time frame: One year
Relationship of AUC cerebral desaturations to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit
Relationship of Assignment Group to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit
Time frame: One year
Relationship of assignment group to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit
Relationship of AUC Cerebral Desaturations to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit
Time frame: One year
Relationship of AUC cerebral desaturations to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit
Relationship of Assignment Group to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility
Time frame: One year
Relationship of assignment group to observed need for postoperative discharge to skilled nursing/rehabilitation facility
Relationship of AUC Cerebral Desaturations to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility
Time frame: One year
Relationship of AUC cerebral desaturations to observed need for postoperative discharge to skilled nursing/rehabilitation facility
Relationship of Assignment Group to Observed Need for Hospital Readmission
Time frame: One year
Relationship of assignment group to observed need for hospital readmission
Relationship of AUC Cerebral Desaturations to Observed Need for Hospital Readmission
Time frame: One year
Relationship of AUC cerebral desaturations to observed need for hospital readmission
Relationship of Assignment Group to Observed Change in CAM or MMSE Scores From Baseline
Time frame: One year
Relationship of assignment group to observed change in CAM or MMSE scores from baseline
Relationship of AUC Cerebral Desaturations to Observed Change in CAM or MMSE Scores From Baseline
Time frame: One year
Relationship of AUC cerebral desaturations to observed change in CAM or MMSE scores from baseline
Relationship of Assignment Group to Observed Change in Renal Function From Baseline
Time frame: One year
Relationship of assignment group to observed change in renal function from baseline
Relationship of AUC Cerebral Desaturations to Observed Change in Renal Function From Baseline
Time frame: One year
Relationship of AUC cerebral desaturations to observed change in renal function from baseline
Relationship of Assignment Group to Observed Time to Return of Bowel Function Time
Time frame: One year
Relationship of assignment group to observed time to return of bowel function time
Relationship of AUC Cerebral Desaturations to Observed Time to Return of Bowel Function Time
Time frame: One year
Relationship of AUC cerebral desaturations to observed time to return of bowel function time
Relationship of Group Assignment to Any Observed Postoperative Infection
Time frame: One year
Relationship of group assignment to any observed postoperative infection
Relationship of AUC Cerebral Desaturations to Any Observed Postoperative Infection
Time frame: One year
Relationship of AUC cerebral desaturations to any observed postoperative infection
Relationship of Assignment Group to Observed Time to Wean From Postoperative Supplemental Oxygen
Time frame: One year
Relationship of assignment group to observed time to wean from postoperative supplemental oxygen
Relationship of AUC Cerebral Desaturations to Observed Time to Wean From Postoperative Supplemental Oxygen
Time frame: One year
Relationship of AUC cerebral desaturations to observed time to wean from postoperative supplemental oxygen
Relationship of Assignment Group to Observed Incidence of Postop Morbidity Composite Endpoint (Defined in Description Section Below)
Time frame: One year
Relationship of assignment group to observed incidence of postop morbidity composite endpoint (defined by having any 1 of the following: new onset afib, ≥Grade 2 PONV, HLOS≥4.5 days, PACU LOS≥2 hours, any infection, death, stroke, MI, greater 0.5 mg/dL increase in Cr or new need for renal dialysis, postop need for IV inotropes or vasoactive meds)
Relationship of AUC Cerebral Desaturations to Observed Incidence of Postoperative Morbidity Composite Endpoint (Defined in Description Section Below)
Time frame: One year
Relationship of AUC cerebral desaturations to observed incidence of postoperative morbidity composite endpoint (defined by having any one of the following: new onset atrial fibrillation, ≥Grade 2 PONV, HLOS≥4.5 days, PACU LOS≥2 hours, any infectious complication, death, stroke, myocardial infarction, greater 0.5 mg/dL increase in creatinine or new need for renal dialysis, postoperative need for intravenous inotropes or vasoactive medications)
4 secondary outcomes
Assess the Frequency of Cerebral Desaturations in Both Cohorts by Examining Both the Total Number of Patients Experiencing Any Cerebral Desaturation as Well as the Total Number of Events Among Patients Experiencing Any Cerebral Desaturation.
Time frame: one year
Adverse Clinical Events and Serious Adverse Events Overall and in Each Cohort
Time frame: one year
Perform a Comprehensive Assessment of the Frequency and Efficacy of Predefined rSO2 Desaturation Mitigation Interventions and Their Collective Ability to Affect the Observed Cerebral Oximetry Values.
Time frame: one year
Assess the Interventional Cohort's Preoperative Demographics and Collected Covariates for Association With the Ease or Difficulty of Mitigating Observed Cerebral Desaturation Events.
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAvery EG. Cerebral oximetry is frequently a "first alert" indicator of adverse outcomes. White paper. October 2010. http://www.somanetics.com/images/stories/pdfs/white-paper-series.pdf Last accessed 08-05-2012
- Background: PubMed 16115985Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.
- Background: PubMed 17179242Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
- Background: PubMed 22311364Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Klick, MD principal investigator
University Hospitals Cleveland Medical Center
Edwin G Avery, MD study director
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasoconstrictor Agents, Head/neck repositioning and Increase ETCO2 in people with Hypoxia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Objective of This Pilot Study is to Identify the Most Relevant Clinical Outcome Variables Which Significantly Diverge as a Result of Being Randomized to the Intervention Cohort vs. the Control Cohort. (time frame: One year). The study lists 61 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866657, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.