Cerebral DesaturationNCT03861026
Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery
A study testing Bilateral NIRS (Masimo, O3TM Regional Oximetry) in people with Cerebral Desaturation and Surgery, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cerebral Desaturation, Surgery
- What is being tested?
- Bilateral NIRS (Masimo, O3TM Regional Oximetry)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Oct 2018to 30 Jun 2023
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 60 years of age
- Undergoing elective major non-cardiac surgery with an anticipated surgical duration of 4 hours or more,
- Preoperative written informed consent.
Who cannot join
- Emergency surgery
- Laparoscopic/Robotic surgery
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Tornoto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Toronto General Hospital, Univerity health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: Role of Cerebral Oximetry In Reducing Postoperative End Organ Dysfunction/Failure After Complex Non- Cardiac Surgery
Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery.
The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients.
Read more
The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM).
A secondary aim is to determine a cost-effectiveness of this monitoring modality.
Read the detailed description
The investigator will collect delirium, stroke, transient ischemic attacks, myocardial infarction (troponin essays), pulmonary embolism (clinical, echocardiography and computer tomography assessments), renal failure (creatinine increase by at least 50% from baseline), pneumonia (clinical, X-ray), atrial fibrillation (documented electrocardiogram), bleeding requiring a transfusion of more than or equal to 4 units of red blood cells within 72 hours of surgery, mechanical ventilation for 2 days, major wound disruption, surgical site infection, sepsis, septic shock, systemic inflammatory response syndrome (vasoactive medication requirement), unplanned return to the operating room, and vascular graft failure, for the duration of hospital stay, as well as, all-cause 30-day mortality. Frailty scale \& DASI questionnaires will be administered at screening visit. Postoperative quality of recovery score (QoR-15) with be performed at baseline, POD 1 \& 5 (discharge if earlier)]. Disability Free Survival (DFS) at 6 months (administer WHODAS).
- Conditions
- Cerebral Desaturation, Surgery
- Being tested
- Bilateral NIRS (Masimo, O3TM Regional Oximetry)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral NIRS (Masimo, O3TM Regional Oximetry)Device
Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. The NIRS electrodes will be placed on fronto-temporal area and baseline values of rSO2 obtained according to manufacturer's guidelines in the operating room prior to induction of anesthesia. The NIRS screen will be concealed in the control group to ensure blinding.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively.
In the interventional group, an alarm threshold at 90% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 90% of the baseline measurements. The intervention will be commenced within 15 seconds of the reduction in rSO2 value. Receives: Device: Bilateral NIRS (Masimo, O3TM Regional Oximetry) |
| Control group | No intervention | Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. In the control group, the cerebral oximetry monitor screen will be concealed, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in cerebral oximetry application and unaware of the study design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite outcome of major end organ dysfunction
A composite outcome will be assessed as a dichotomous outcome. (YES or NO). All components of the composite outcome will be weighted equally. They will include the following outcomes: postoperative delirium assessed with Confusion Assessment Method (CAM), Stroke assessed clinically, Transient Ischemic Attacks assessed clinically, Myocardial infarction, Pulmonary Embolism, Renal failure, Pneumonia, Atrial fibrillation, bleeding, mechanical ventilation for ≥48 hours, Major wound disruption, Surgical site infection, Sepsis, Septic shock, Systemic inflammatory response syndrome, Vascular graft failure. Frailty scale \& DASI questionnaires will be administered at screening visit.
Postoperative quality of recovery score (QoR-15) with be performed at baseline, POD 1 \& 5 (discharge if earlier)]. Disability Free Survival (DFS) at 6 months (WHODAS).
Measured: surgery date to 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start5 Oct 2018
- Primary completion30 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral DesaturationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Djaiani, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861026
- Sponsor's protocol ID
- 16-5747
- Status last verified
- Dec 2024
- First submitted
- 15 May 2018
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cerebral Oximetry In Reducing Postoperative End Organ Dysfunction/Failure After Complex Non- Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03861026
- Acronym / sponsor ID
- 16-5747
- Conditions
- Cerebral Desaturation, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Mar 2019 (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.
Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery.
The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients.
The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM).
A secondary aim is to determine a cost-effectiveness of this monitoring modality.
Detailed description
The investigator will collect delirium, stroke, transient ischemic attacks, myocardial infarction (troponin essays), pulmonary embolism (clinical, echocardiography and computer tomography assessments), renal failure (creatinine increase by at least 50% from baseline), pneumonia (clinical, X-ray), atrial fibrillation (documented electrocardiogram), bleeding requiring a transfusion of more than or equal to 4 units of red blood cells within 72 hours of surgery, mechanical ventilation for 2 days, major wound disruption, surgical site infection, sepsis, septic shock, systemic inflammatory response syndrome (vasoactive medication requirement), unplanned return to the operating room, and vascular graft failure, for the duration of hospital stay, as well as, all-cause 30-day mortality. Frailty scale \& DASI questionnaires will be administered at screening visit. Postoperative quality of recovery score (QoR-15) with be performed at baseline, POD 1 \& 5 (discharge if earlier)]. Disability Free Survival (DFS) at 6 months (administer WHODAS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Bilateral NIRS (Masimo, O3TM Regional Oximetry)Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. In the interventional group, an alarm threshold at 90% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 90% of the baseline measurements. The intervention will be commenced within 15 seconds of the reduction in rSO2 value. |
| Control group | No intervention | –Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. In the control group, the cerebral oximetry monitor screen will be concealed, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in cerebral oximetry application and unaware of the study design. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 60 years of age
- Undergoing elective major non-cardiac surgery with an anticipated surgical duration of 4 hours or more,
- Preoperative written informed consent.
Key exclusion criteria (2 listed)
- Emergency surgery
- Laparoscopic/Robotic surgery
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 |
|---|---|---|
| Bilateral NIRS (Masimo, O3TM Regional Oximetry)Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. The NIRS electrodes will be placed on fronto-temporal area and baseline values of rSO2 obtained according to manufacturer's guidelines in the operating room prior to induction of anesthesia. The NIRS screen will be concealed in the control group to ensure blinding. | Device | Intervention group |
Primary outcome
A composite outcome of major end organ dysfunction
Time frame: surgery date to 6 months post surgery
A composite outcome will be assessed as a dichotomous outcome. (YES or NO). All components of the composite outcome will be weighted equally. They will include the following outcomes: postoperative delirium assessed with Confusion Assessment Method (CAM), Stroke assessed clinically, Transient Ischemic Attacks assessed clinically, Myocardial infarction, Pulmonary Embolism, Renal failure, Pneumonia, Atrial fibrillation, bleeding, mechanical ventilation for ≥48 hours, Major wound disruption, Surgical site infection, Sepsis, Septic shock, Systemic inflammatory response syndrome, Vascular graft failure. Frailty scale \& DASI questionnaires will be administered at screening visit. Postoperative quality of recovery score (QoR-15) with be performed at baseline, POD 1 \& 5 (discharge if earlier)]. Disability Free Survival (DFS) at 6 months (WHODAS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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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.
George Djaiani principal investigator
Toronto General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral NIRS (Masimo, O3TM Regional Oximetry) in people with Cerebral Desaturation and Surgery, run by University Health Network, Toronto at 2 sites 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 2 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: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A composite outcome of major end organ dysfunction (time frame: surgery date to 6 months post surgery). 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 11 Dec 2024.