Critical IllnessCONFOCAL-2NCT03141619
Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2
An observational study of Critical Illness and Respiratory Failure, run by Dr. Gordon Boyd at 1 site in Canada.
Trial summary
This study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. We use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Respiratory Failure, Shock
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2017to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will be enrolling consecutive patients meeting eligibility criteria from each site in this multi-centred study.
Who may be able to join
- Adults ≥ 18 years old
- Admitted to a critical care unit requiring one or more of the following:
- Respiratory failure requiring invasive mechanical ventilation with an expected duration >24 hours (b) Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: (i) Dopamine ≥7.5 mcg/kg/min (ii) Dobutamine ≥5 mcg/kg/min (iii) Norepinephrine ≥5 mcg/min (iv) Phenylephrine ≥75 mcg/min (v) Epinephrine at any dose (vi) Milrinone at any dose (if used in conjunction with another agent) (vii) Vasopressin ≥0.03 u/min(if used in conjunction with another agent)
Who cannot join
- Admission to the ICU > 24 hours
- Life expectancy <24 hours
- Admitting diagnosis that affects the central nervous system
- Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kingston General Hospital
Kingston, Ontario, K7L3V7
John G Boyd, MD, PhD, 613-549-6666 ext. 6228, 2jgb1@queensu.ca
About this study
This study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. We use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative impairments on robotic testing (KINARM robot) and traditional neuropsychological screening (Repeatable Battery for the Assessment of Neuropsychological Status).
- Conditions
- Critical Illness, Respiratory Failure, Shock, Delirium
- Keywords
- cerebral oximetry, near-infrared spectroscopy, neurocognitive, post-ICU syndrome
- Medical subject headings
- Critical Illness, Respiratory Insufficiency, Shock, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory failure and/or shock | All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral oxygenation (rSO2) and delirium
Multivariate linear regression will be used to characterize the association between poor cerebral perfusion (as measured using duration of time (minutes) outside of MAPOPT, mean rSO2, and duration of disturbed cerebral autoregulation) and delirium severity to determine if poor cerebral perfusion is an independent predictor of delirium severity. We will estimate the unadjusted effect of each individual predictor on delirium severity (i.e., cumulative CAM-7 scores per patient). The simultaneous multivariate regression model will adjust for the following covariates (sex, a history of hypertension, a history of alcohol abuse, total sedative dose (in midazolam equivalents), total narcotic dose (fentanyl equivalents), severity of illness (APACHE II scores), pre-existing cognitive impairment (CDR score), length of ICU stay, and blood urea nitrogen. The multivariable model will provide the adjusted regression coefficients after controlling for all predictors included in the model.
Measured: 30 days
Secondary outcomes (2)
Assessment of secondary outcomes-physiological determinants of cerebral oxygenation
To assess the physiological determinants of rSO2, multiple linear regression will be performed using the patient average of each variable over the 72 hour data collection period. The following predictors will be included in the regression model: heart rate (HR), arterial oxygen saturation (SpO2), MAP, arterial blood gas data (i.e., pH, partial pressure of oxygen, and partial pressure of carbon dioxide), central venous oxygen saturation, and hemoglobin concentration (Hb). In addition, the multivariate model will control for the following covariates associated with cerebral perfusion: sex, age, as well as total sedative, narcotic, and vasopressor dosing. Simultaneous multiple linear regression with adjustment for all aforementioned covariates will be implemented. A within patient repeated measures analysis will also be performed by using the linear mixed effects model with 6 observations per subject reflecting each 12 hour period during the 72 hour data collection period.
Measured: 72 hours
Cerebral oxygenation as an independent risk factor for long-term cognitive impairment-RBANS
Multiple linear regression analysis will be used to assess if poor cerebral perfusion (i.e. time below MAPOPT, mean rSO2, duration of disturbed cerebral autoregulation) is associated with RBANS global cognition scores at 3- and 12-months post-ICU discharge. We will use the following clinical covariates collected on admission (i.e., pre-existing cognitive impairment, age, severity of illness) and data collected within the first 72 hours of the patients' ICU stay (i.e., narcotic dosing and benzodiazepine dosing). All covariates will be adjusted for in separate regression models for the cognitive outcomes at 3- and 12-months post-ICU discharge. If global cognition is significantly predicted by the impaired cerebral perfusion, we will conduct an exploratory analysis of the RBANS subdomains of cognition (i.e., delay and immediate memory, language, attention, visuospatial/constructional) adjusting for the aforementioned covariates to further explore specific domains of impairment.
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start13 Oct 2017
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gordon Boyd
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Vancouver General Hospital, Western University, Canada, University of Ottawa, Université de Montréal, University of Calgary, University of Pittsburgh
- Responsible party
- Sponsor-investigator, Dr. Gordon Boyd, Queen's University
- Investigators
- J. Gordon Boyd, MD, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141619
- Sponsor's protocol ID
- CTO Project ID 0815
- Acronym
- CONFOCAL-2
- Status last verified
- Dec 2023
- First submitted
- 1 May 2017
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khan JM, Wood MD, Lee KFH, Maslove D, Muscedere J, English SW, Ball I, Slessarev M, Boyd JG. Delirium, Cerebral Perfusion, and High-Frequency Vital-Sign Monitoring in the Critically Ill. The CONFOCAL-2 Feasibility Study. Ann Am Thorac Soc. 2021 Jan;18(1):112-121. doi: 10.1513/AnnalsATS.202002-093OC.
PubMed 32780600Wood MD, Khan J, Lee KFH, Maslove DM, Muscedere J, Hunt M, Scott SH, Day A, Jacobson JA, Ball I, Slessarev M, O'Regan N, English SW, McCredie V, Chasse M, Griesdale D, Boyd JG. Assessing the relationship between near-infrared spectroscopy-derived regional cerebral oxygenation and neurological dysfunction in critically ill adults: a prospective observational multicentre protocol, on behalf of the Canadian Critical Care Trials Group. BMJ Open. 2019 Jun 25;9(6):e029189. doi: 10.1136/bmjopen-2019-029189.
PubMed 31243036
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2
- ClinicalTrials.gov ID
- NCT03141619
- Acronym / sponsor ID
- CONFOCAL-2 / CTO Project ID 0815
- Conditions
- Critical Illness, Respiratory Failure, Shock, Delirium
- Keywords
- cerebral oximetry, near-infrared spectroscopy, neurocognitive, post-ICU syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr. Gordon BoydUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Vancouver General Hospital, Western University, Canada, University of Ottawa, Université de Montréal, University of Calgary, University of Pittsburgh
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. We use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative impairments on robotic testing (KINARM robot) and traditional neuropsychological screening (Repeatable Battery for the Assessment of Neuropsychological Status).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory failure and/or shock | – | –All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will be enrolling consecutive patients meeting eligibility criteria from each site in this multi-centred study.
Key inclusion criteria (3 listed)
- Adults ≥ 18 years old
- Admitted to a critical care unit requiring one or more of the following:
Key exclusion criteria (4 listed)
- Admission to the ICU > 24 hours
- Life expectancy <24 hours
- Admitting diagnosis that affects the central nervous system
- Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional cerebral oxygenation (rSO2) and delirium
Time frame: 30 days
Multivariate linear regression will be used to characterize the association between poor cerebral perfusion (as measured using duration of time (minutes) outside of MAPOPT, mean rSO2, and duration of disturbed cerebral autoregulation) and delirium severity to determine if poor cerebral perfusion is an independent predictor of delirium severity. We will estimate the unadjusted effect of each individual predictor on delirium severity (i.e., cumulative CAM-7 scores per patient). The simultaneous multivariate regression model will adjust for the following covariates (sex, a history of hypertension, a history of alcohol abuse, total sedative dose (in midazolam equivalents), total narcotic dose (fentanyl equivalents), severity of illness (APACHE II scores), pre-existing cognitive impairment (CDR score), length of ICU stay, and blood urea nitrogen. The multivariable model will provide the adjusted regression coefficients after controlling for all predictors included in the model.
2 secondary outcomes
Assessment of secondary outcomes-physiological determinants of cerebral oxygenation
Time frame: 72 hours
Cerebral oxygenation as an independent risk factor for long-term cognitive impairment-RBANS
Time frame: 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 32780600Khan JM, Wood MD, Lee KFH, Maslove D, Muscedere J, English SW, Ball I, Slessarev M, Boyd JG. Delirium, Cerebral Perfusion, and High-Frequency Vital-Sign Monitoring in the Critically Ill. The CONFOCAL-2 Feasibility Study. Ann Am Thorac Soc. 2021 Jan;18(1):112-121. doi: 10.1513/AnnalsATS.202002-093OC.
- Derived from this study: PubMed 31243036Wood MD, Khan J, Lee KFH, Maslove DM, Muscedere J, Hunt M, Scott SH, Day A, Jacobson JA, Ball I, Slessarev M, O'Regan N, English SW, McCredie V, Chasse M, Griesdale D, Boyd JG. Assessing the relationship between near-infrared spectroscopy-derived regional cerebral oxygenation and neurological dysfunction in critically ill adults: a prospective observational multicentre protocol, on behalf of the Canadian Critical Care Trials Group. BMJ Open. 2019 Jun 25;9(6):e029189. doi: 10.1136/bmjopen-2019-029189.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
J. Gordon Boyd, MD, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Respiratory Failure, run by Dr. Gordon Boyd at 1 site in Canada.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J. Gordon Boyd, MD, PhD (613-549-6666 ext. 6228, boydj@kgh.kari.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional cerebral oxygenation (rSO2) and delirium (time frame: 30 days). 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 NCT03141619, which also lists 2 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 26 Dec 2023.