Regional Cerebral Oxygen SaturationNCT02101242
Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study
An observational study of Regional Cerebral Oxygen Saturation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery. Regional cerebral oxygen saturation will be measured continuously during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Cerebral Oxygen Saturation
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2014to 17 Sep 2014
- 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: Patients of both genders, over 18 years of age, undergoing elective surgery in general anesthesia.
Who may be able to join
- patients with male-to-female ratio approaching 1:1
- age ≥ 18 years
- scheduled duration of surgery longer than or equal to 60 minutes
- patients undergoing one of the following procedures:
- orthopedic surgery of the shoulder in beach chair position
- gynecological, urological or general surgery in Trendelenburg's position
- cardiac surgery
Who cannot join
- Moribund patients
- Persons without the capacity to consent
- Unability of German language use
- Inability of communication due to severe hearing and severe vision impairments
- Accommodation in an institution due to an official or judicial order
- Co-worker of the Charité
Show all 10Show fewer
- Participation in another interventional study within 30 days before participation in this study
- Alcohol- use disorders according to the Alcohol Use Disorders Identification Test (AUDIT)
- Preoperative Dementia (Minimal Mental State Examination < 24)
- Stroke, traumatic brain injury within the last 12 months or patients with residual neurological deficits
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin
Berlin, 10117
About this study
A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery. Regional cerebral oxygen saturation will be measured continuously during surgery. Duration and extent of deviations from individual baseline values will be recorded and detected deviations treated according to their clinically apparent cause (e.g. hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with our standard operating procedures (SOPs).
Patients are then followed up until the end of hospital stay or for a maximum of 10 days after surgery. Their level of cognitive function will be tested and compared to the data acquired before surgery to detect impairment, delirium or postoperative cognitive deficit (POCD).
The purpose of this pilot study is to evaluate the design and conduct of a projected full scale observational clinical study.
Read the detailed description
The primary goal of this study is the detection of perioperative fluctuations of regional cerebral oxygen saturation in patients undergoing surgery in general anaesthesia. These fluctuations will be monitored using the a non-invasive monitoring system based on the method of near-infrared spectroscopy (NIRS).
Regional cerebral hypoxia is considered one of the possible precipitating factors of postsurgical cognitive impairment (as seen in patients with postoperative cognitive deficit or postoperative delirium), but without monitoring it may easily remain undetected. A differentiated analysis of fluctuations is gained by calculation of the area under curve (AUC) of a defined deviation from individual baseline regional cerebral oxygen saturation (rSO2) over time.
When deviations are detected, they will be treated in this study according to their clinically apparent cause (e.g. hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with current standard operating procedures (SOPs) to re-elevate regional cerebral oxygen saturation (rSO2) to within 20% of baseline.
Among these procedures are
- Elevation of systemic arterial pressure by application of vasopressors
- Consideration of systemic (pulse oxymetric) oxygen saturation
- Adjustment of artificial ventilation subject to endexpiratory concentration of carbon dioxide (CO2)
- Transfusion of concentrated red cells in case of Hemoglobin (Hb) <7-9 g/dl
- Transthoracic or transesophageal echocardiogram (TTE/TEE) and assessment of centralvenous oxygen saturation in case of suspected myocardial insufficiency which should be applied to patients of the 3 defined groups as needed.
This explorative project is a pilot study.
- Conditions
- Regional Cerebral Oxygen Saturation
- Keywords
- Near-infrared-Spectroscopy
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 |
|---|---|---|
| Orthopedic surgery of the shoulder | Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to beach chair position. | |
| Gynecological, urological or general surgery | Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to Trendelenburg position. | |
| Cardiac surgery | Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation in patients undergoing cardiac surgery with cardiopulmonary bypass (heart-lung machine). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral oxygen saturation (rSO2)
Regional cerebral oxygen saturation (rSO2) is measured under different body positions for elective surgery
Measured: Duration of elective surgery (an average of 2 hours)
Secondary outcomes (6)
Incidence and severity of postoperative delirium
Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM-ICU), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-V) (DSM-V), International Classification of Diseases (ICD)-10 (ICD-10)
Measured: In the 10 - day postoperative sample period
Incidence and severity of postoperative cognitive dysfunction
Test battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test
Measured: In the 10-day postoperative sample period
Rate of organ complications
Measured: In the 10-day postoperative sample period
Electrical activity of the brain
Electrical activity of the brain is measured by electroencephalogram (EEG-derived) bispectral index (BIS) monitoring
Measured: Duration of elective surgery (an average of 2 hours)
Somatic cerebral oxygen saturation (sSO2)
Somatic cerebral oxygen saturation (rSO2) of the lower limbs (absolutely and in side comparison) in cardiac surgery patients
Measured: Duration of elective surgery (an average of 2 hours)
Hospital length of stay
Post-anaesthesia Discharge Scoring System (PADSS)
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start11 May 2014
- Primary completion14 Sep 2014
- Study completion17 Sep 2014
Why it stopped: Cardiac surgery group could not be measured (technical monitoring problems)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Cerebral Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101242
- Sponsor's protocol ID
- ReCOSA
- Status last verified
- Jun 2019
- First submitted
- 13 Mar 2014
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study
- ClinicalTrials.gov ID
- NCT02101242
- Acronym / sponsor ID
- ReCOSA
- Conditions
- Regional Cerebral Oxygen Saturation
- Keywords
- Near-infrared-Spectroscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Cardiac surgery group could not be measured (technical monitoring problems)
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 11 May 2014 (actual)
- Primary completion
- 14 Sep 2014 (actual)
- Study completion
- 17 Sep 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- 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.
A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery. Regional cerebral oxygen saturation will be measured continuously during surgery. Duration and extent of deviations from individual baseline values will be recorded and detected deviations treated according to their clinically apparent cause (e.g. hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with our standard operating procedures (SOPs).
Patients are then followed up until the end of hospital stay or for a maximum of 10 days after surgery. Their level of cognitive function will be tested and compared to the data acquired before surgery to detect impairment, delirium or postoperative cognitive deficit (POCD).
The purpose of this pilot study is to evaluate the design and conduct of a projected full scale observational clinical study.
Detailed description
The primary goal of this study is the detection of perioperative fluctuations of regional cerebral oxygen saturation in patients undergoing surgery in general anaesthesia. These fluctuations will be monitored using the a non-invasive monitoring system based on the method of near-infrared spectroscopy (NIRS).
Regional cerebral hypoxia is considered one of the possible precipitating factors of postsurgical cognitive impairment (as seen in patients with postoperative cognitive deficit or postoperative delirium), but without monitoring it may easily remain undetected. A differentiated analysis of fluctuations is gained by calculation of the area under curve (AUC) of a defined deviation from individual baseline regional cerebral oxygen saturation (rSO2) over time.
When deviations are detected, they will be treated in this study according to their clinically apparent cause (e.g. hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with current standard operating procedures (SOPs) to re-elevate regional cerebral oxygen saturation (rSO2) to within 20% of baseline.
Among these procedures are
- Elevation of systemic arterial pressure by application of vasopressors
- Consideration of systemic (pulse oxymetric) oxygen saturation
- Adjustment of artificial ventilation subject to endexpiratory concentration of carbon dioxide (CO2)
- Transfusion of concentrated red cells in case of Hemoglobin (Hb) <7-9 g/dl
- Transthoracic or transesophageal echocardiogram (TTE/TEE) and assessment of centralvenous oxygen saturation in case of suspected myocardial insufficiency which should be applied to patients of the 3 defined groups as needed.
This explorative project is a pilot study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orthopedic surgery of the shoulder | – | –Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to beach chair position. |
| Gynecological, urological or general surgery | – | –Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to Trendelenburg position. |
| Cardiac surgery | – | –Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation in patients undergoing cardiac surgery with cardiopulmonary bypass (heart-lung machine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both genders, over 18 years of age, undergoing elective surgery in general anesthesia.
Key inclusion criteria (7 listed)
- patients with male-to-female ratio approaching 1:1
- age ≥ 18 years
- scheduled duration of surgery longer than or equal to 60 minutes
- patients undergoing one of the following procedures:
Key exclusion criteria (10 listed)
- Moribund patients
- Persons without the capacity to consent
- Unability of German language use
- Inability of communication due to severe hearing and severe vision impairments
- Accommodation in an institution due to an official or judicial order
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 oxygen saturation (rSO2)
Time frame: Duration of elective surgery (an average of 2 hours)
Regional cerebral oxygen saturation (rSO2) is measured under different body positions for elective surgery
6 secondary outcomes
Incidence and severity of postoperative delirium
Time frame: In the 10 - day postoperative sample period
Incidence and severity of postoperative cognitive dysfunction
Time frame: In the 10-day postoperative sample period
Rate of organ complications
Time frame: In the 10-day postoperative sample period
Electrical activity of the brain
Time frame: Duration of elective surgery (an average of 2 hours)
Somatic cerebral oxygen saturation (sSO2)
Time frame: Duration of elective surgery (an average of 2 hours)
Hospital length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
The study was stopped early (reason given: Cardiac surgery group could not be measured (technical monitoring problems)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Regional Cerebral Oxygen Saturation, run by Charite University, Berlin, Germany at 1 site in Germany.
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 7 inclusion and 10 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 28 Jun 2019. 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 Germany. 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?
The study was stopped early (reason given: Cardiac surgery group could not be measured (technical monitoring problems)). Results are not available in the source record.
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?
Regional cerebral oxygen saturation (rSO2) (time frame: Duration of elective surgery (an average of 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2019.