StrokeNCT05752981
Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Prevention of Perioperative Brain Injury
An observational study of Stroke and Cerebral Oxygenation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Covert stroke occurs in one out of fourteen patients during or shortly after surgery, and may result in long-term disability. Fortunately, stroke that occurs during non-cardiac surgery is most commonly caused by inadequate blood flow to the brain and is, therefore, preventable if it can be detected early. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Oxygenation
- What is being tested?
- multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2023to 31 Dec 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
- Adult, Older adult
Study population: Shoulder surgery patients were chosen as the study population because of the high frequency of intraoperative hypotensive and cerebral desaturation events that may occur during this procedure, and the unique physiological changes such as impaired cerebral autoregulation that accompany the beach chair surgical positioning. This unique but commonly encountered operative condition create ischemic challenges and injury to the brain and provide opportunities to assess the spatial and temporal differences of cerebral desaturation patterns experienced during hypotensive and other physiological challenges, and to refine the tr-fNIRS device for perioperative applications.
Who may be able to join
- Adult patients (age ≥ 18 years old)
- Scheduled to have elective shoulder surgery in the beach-chair position under general anesthesia
- Provide informed consent
Who cannot join
- have skin/scalp lesions that preclude the application of fNIRS device to the head ii) lack of written consent iii) emergency surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Jason Chui, MD, 5196858500 ext. 34435, jason.chui@lhsc.on.ca
About this study
Official title: Full-head Coverage Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Early Detection and Prevention of Perioperative Brain Injury
Covert stroke occurs in one out of fourteen patients during or shortly after surgery, and may result in long-term disability. Fortunately, stroke that occurs during non-cardiac surgery is most commonly caused by inadequate blood flow to the brain and is, therefore, preventable if it can be detected early. Current clinical tools used to monitor the brain during surgery do not have the accuracy nor the spatial coverage - they only monitor one small region of the brain. In this study, the investigators plan to apply a cutting-edge optical device, tr-fNIRS, to monitor the whole brain during shoulder surgery. The primary aim is to determine any regional differences in cerebral oxygenation (ScO2) and cerebral autoregulation (CA)between brain regions during surgery and especially during various physiological challenges, such as hypotension. The investigators hypothesize that certain brain regions are more likely to develop cerebral desaturation and impaired CA, and are more prone to brain injury than the frontal lobe region which is the traditional monitoring site. The investigators also hypothesize that cerebral desaturation (or hypoxic injury) events correlate with adverse postoperative neurological outcomes such as covert stroke, overt stroke and/or postoperative delirium.
Read the detailed description
Perioperative stroke is a significant complication after surgery. Unfortunately, covert stroke occurs in one out of fourteen elderly patients after non-cardiac surgery and is associated with an increased risk of long-term cognitive decline. Further, perioperative overt stroke is associated with an 8-fold increase in perioperative mortality, prolonged length of hospital stay, and decreased quality of life. For shoulder surgery performed in the beach chair position, due to systemic hypotension and reduction in cerebral perfusion pressure, cerebral desaturation events and impaired cerebral autoregulation can occur in up to 80% of patients. Most perioperative stroke in non-cardiac surgery is ischemic and is related to brain hypoperfusion. Importantly, brain hypoperfusion is potentially modifiable with simple measures such as increasing systemic blood pressure (BP) if brain ischemia is identified early enough. However, deliberate hypertension is not devoid of risk and there is currently no effective monitor that can detect brain hypoperfusion during surgery.
Cerebral oxygenation has been used clinically as a measure of adequate brain perfusion during surgery. An early clinical trial at Western found that monitoring cerebral oxygenation was associated with fewer cases of major organ dysfunction in cardiac surgery patients. Despite this promising initial finding, current commercial cerebral oximeters have a number of limitations that prevent reliable perioperative neuromonitoring, including non-specificity due to signal contamination from extracerebral tissue, especially during administration of vasoconstrictors or hypothermia. In addition, current commercial cerebral oximeters only have two channels to monitor the frontal lobe regions (i.e., anterior cerebral artery territory). This monitoring strategy assumes that cerebral oxygenation is homogenous across different brain regions so that measurements from the frontal lobe regions can be used clinically to represent the adequacy of global brain oxygenation. Such a limited spatial coverage may result in undetected stroke, despite the patients having apparently normal cerebral oxygenation in the frontal regions throughout surgery. The current research project employs multi-channel tr-fNIRS to address these limitations, with the goal of timely detection and prevention of ischemic brain injury.
Multi-channel tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) is an emerging brain-imaging technology that was originally developed to explore changes in cerebral oxygenation generated by cortical neuronal activity during various cognitive tasks such as speech, sensory and motor functions, and emotion. This is because tr-fNIRS can measure such subtle cerebral oxygenation changes in milliseconds (up to 100 ms) that accompany neuro-activation such as finger-tapping. The investigators has built several tr-fNIRS devices and have the expertise of adapting the full head coverage tr-fNIRS device to perioperative neuromonitoring. Furthermore, tr-fNIRS operate by sending short (picosecond) pulses of light into the head and precisely measures the time of travel of each photon in the tissue. Since there is an equivalence between time and distance, photons that are detected right after the pulse have only probed the extracerebral layers (scalp and skull) while photons that are detected long after (1-2 ms) the pulse have travelled deep into the brain tissues. The investigators have recently shown that this approach reduces the signal contaminations of the extracerebral layers from 80% with current commercial NIRS devices to less than 8% with tr-fNIRS. In this study, the investigators will employ a state-of-the-art full head coverage tr-fNIRS device to monitor the entire brain, as opposed to only select regions (such as the limited capabilities of the current cerebral oximeters) in the perioperative setting. Together with in-house analysis algorithms, the full head coverage tr-fNIRS can detect specific brain regions at-risk of ischemic injury with a high degree of certainty because of greater spatial resolution (in cm) and less signal contamination from extracerebral tissue.
All study participants will be recruited and consented adhering to the local ethics guidelines. For all study participants, the surgical and anesthetic management of the patients will be conducted in a standard fashion and will not be altered in this study. The exception is that tr-fNIRS will be used to monitor regional brain oxygenation from anesthesia induction to completion of surgery. The surgeons, anesthesiologists, and nurses will be blinded to the monitor/measurements during the procedure. No intervention will be administered based on the results of the tr-fNIRS.
- Conditions
- Stroke, Cerebral Oxygenation
- Being tested
- multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)
- Keywords
- neuromonitoring, cerebral oxygenation, stroke, anesthesia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)Device
Participants will be monitored during surgery using the multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS). This study is observational in nature and no intervention will be applied based on the results of the tr-fNIRS device.
| Study group | Role | What they receive |
|---|---|---|
| tr-FNIRS neuromonitor | During shoulder surgery, the tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) neuromonitor will be used to gather data on cerebral oxygenation of multiple brain regions for these patients. No intervention will be administered based on the results of the tr-fNIRS. Receives: Device: multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of intraoperative hemodynamic parameter on regional differences in cerebral oxygenation (ScO2) between brain regions during surgery
cerebral oxygenation (ScO2) between brain regions will be done by assessing the data collected by the tr-fNIRS monitor during surgery.
Measured: Duration of surgical procedure
Secondary outcomes (2)
Regional differences in cerebral autoregulation in beach-chair position under general anesthesia as measured by the tr-fNIRS monitor (Hz) data outputs.
Cerebral autoregulation index will be calculated based on the data collected by the tr-fNIRS monitor during surgery.
Measured: Duration of surgery
To assess the association between cerebral desaturation (or hypoxic injury) events in multiple brain regions to clinical outcomes such as stroke and delirium
Covert stroke will be assessed by performing a postoperative MRI. Neurological deficits will be assessed by physical examination and delirium will be assessed by 3D CAM administration).
Measured: Up to 72 hours following surgery or until discharge from hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start16 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Chui, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Jason Chui, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752981
- Sponsor's protocol ID
- tr-fNIRS
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mrkobrada M, Hill MD, Chan MT, Sigamani A, Cowan D, Kurz A, Sessler DI, Jacka M, Graham M, Dasgupta M, Dunlop V, Emery DJ, Gulka I, Guyatt G, Heels-Ansdell D, Murkin J, Pettit S, Sahlas DJ, Sharma M, Sharma M, Srinathan S, St John P, Tsai S, Gelb AW, O'Donnell M, Siu D, Chiu PW, Sharath V, George A, Devereaux PJ. Covert stroke after non-cardiac surgery: a prospective cohort study. Br J Anaesth. 2016 Aug;117(2):191-7. doi: 10.1093/bja/aew179.
PubMed 27440630Mashour GA, Shanks AM, Kheterpal S. Perioperative stroke and associated mortality after noncardiac, nonneurologic surgery. Anesthesiology. 2011 Jun;114(6):1289-96. doi: 10.1097/ALN.0b013e318216e7f4.
PubMed 21478735NeuroVISION Investigators. Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019 Sep 21;394(10203):1022-1029. doi: 10.1016/S0140-6736(19)31795-7. Epub 2019 Aug 15.
PubMed 31422895Salazar JD, Wityk RJ, Grega MA, Borowicz LM, Doty JR, Petrofski JA, Baumgartner WA. Stroke after cardiac surgery: short- and long-term outcomes. Ann Thorac Surg. 2001 Oct;72(4):1195-201; discussion 1201-2. doi: 10.1016/s0003-4975(01)02929-0.
PubMed 11603436McCulloch TJ, Liyanagama K, Petchell J. Relative hypotension in the beach-chair position: effects on middle cerebral artery blood velocity. Anaesth Intensive Care. 2010 May;38(3):486-91. doi: 10.1177/0310057X1003800312.
PubMed 20514957Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
PubMed 20508134Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15.
PubMed 23415820Lee JH, Min KT, Chun YM, Kim EJ, Choi SH. Effects of beach-chair position and induced hypotension on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery. Arthroscopy. 2011 Jul;27(7):889-94. doi: 10.1016/j.arthro.2011.02.027. Epub 2011 May 28.
PubMed 21620637Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.
PubMed 29889106Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.
PubMed 22104067Ono M, Joshi B, Brady K, Easley RB, Zheng Y, Brown C, Baumgartner W, Hogue CW. Risks for impaired cerebral autoregulation during cardiopulmonary bypass and postoperative stroke. Br J Anaesth. 2012 Sep;109(3):391-8. doi: 10.1093/bja/aes148. Epub 2012 Jun 1.
PubMed 22661748Brady KM, Hudson A, Hood R, DeCaria B, Lewis C, Hogue CW. Personalizing the Definition of Hypotension to Protect the Brain. Anesthesiology. 2020 Jan;132(1):170-179. doi: 10.1097/ALN.0000000000003005. No abstract available.
PubMed 31644437Lee JM, Grabb MC, Zipfel GJ, Choi DW. Brain tissue responses to ischemia. J Clin Invest. 2000 Sep;106(6):723-31. doi: 10.1172/JCI11003. No abstract available.
PubMed 10995780Murkin 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 17179242Grocott HP, Davie SN. Future uncertainties in the development of clinical cerebral oximetry. Front Physiol. 2013 Dec 18;4:360. doi: 10.3389/fphys.2013.00360. eCollection 2013. No abstract available.
PubMed 24385967
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-head Coverage Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Early Detection and Prevention of Perioperative Brain Injury
- ClinicalTrials.gov ID
- NCT05752981
- Acronym / sponsor ID
- tr-fNIRS
- Conditions
- Stroke, Cerebral Oxygenation
- Keywords
- neuromonitoring, cerebral oxygenation, stroke, anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Mar 2023 (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.
Covert stroke occurs in one out of fourteen patients during or shortly after surgery, and may result in long-term disability. Fortunately, stroke that occurs during non-cardiac surgery is most commonly caused by inadequate blood flow to the brain and is, therefore, preventable if it can be detected early. Current clinical tools used to monitor the brain during surgery do not have the accuracy nor the spatial coverage - they only monitor one small region of the brain. In this study, the investigators plan to apply a cutting-edge optical device, tr-fNIRS, to monitor the whole brain during shoulder surgery. The primary aim is to determine any regional differences in cerebral oxygenation (ScO2) and cerebral autoregulation (CA)between brain regions during surgery and especially during various physiological challenges, such as hypotension. The investigators hypothesize that certain brain regions are more likely to develop cerebral desaturation and impaired CA, and are more prone to brain injury than the frontal lobe region which is the traditional monitoring site. The investigators also hypothesize that cerebral desaturation (or hypoxic injury) events correlate with adverse postoperative neurological outcomes such as covert stroke, overt stroke and/or postoperative delirium.
Detailed description
Perioperative stroke is a significant complication after surgery. Unfortunately, covert stroke occurs in one out of fourteen elderly patients after non-cardiac surgery and is associated with an increased risk of long-term cognitive decline. Further, perioperative overt stroke is associated with an 8-fold increase in perioperative mortality, prolonged length of hospital stay, and decreased quality of life. For shoulder surgery performed in the beach chair position, due to systemic hypotension and reduction in cerebral perfusion pressure, cerebral desaturation events and impaired cerebral autoregulation can occur in up to 80% of patients. Most perioperative stroke in non-cardiac surgery is ischemic and is related to brain hypoperfusion. Importantly, brain hypoperfusion is potentially modifiable with simple measures such as increasing systemic blood pressure (BP) if brain ischemia is identified early enough. However, deliberate hypertension is not devoid of risk and there is currently no effective monitor that can detect brain hypoperfusion during surgery.
Cerebral oxygenation has been used clinically as a measure of adequate brain perfusion during surgery. An early clinical trial at Western found that monitoring cerebral oxygenation was associated with fewer cases of major organ dysfunction in cardiac surgery patients. Despite this promising initial finding, current commercial cerebral oximeters have a number of limitations that prevent reliable perioperative neuromonitoring, including non-specificity due to signal contamination from extracerebral tissue, especially during administration of vasoconstrictors or hypothermia. In addition, current commercial cerebral oximeters only have two channels to monitor the frontal lobe regions (i.e., anterior cerebral artery territory). This monitoring strategy assumes that cerebral oxygenation is homogenous across different brain regions so that measurements from the frontal lobe regions can be used clinically to represent the adequacy of global brain oxygenation. Such a limited spatial coverage may result in undetected stroke, despite the patients having apparently normal cerebral oxygenation in the frontal regions throughout surgery. The current research project employs multi-channel tr-fNIRS to address these limitations, with the goal of timely detection and prevention of ischemic brain injury.
Multi-channel tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) is an emerging brain-imaging technology that was originally developed to explore changes in cerebral oxygenation generated by cortical neuronal activity during various cognitive tasks such as speech, sensory and motor functions, and emotion. This is because tr-fNIRS can measure such subtle cerebral oxygenation changes in milliseconds (up to 100 ms) that accompany neuro-activation such as finger-tapping. The investigators has built several tr-fNIRS devices and have the expertise of adapting the full head coverage tr-fNIRS device to perioperative neuromonitoring. Furthermore, tr-fNIRS operate by sending short (picosecond) pulses of light into the head and precisely measures the time of travel of each photon in the tissue. Since there is an equivalence between time and distance, photons that are detected right after the pulse have only probed the extracerebral layers (scalp and skull) while photons that are detected long after (1-2 ms) the pulse have travelled deep into the brain tissues. The investigators have recently shown that this approach reduces the signal contaminations of the extracerebral layers from 80% with current commercial NIRS devices to less than 8% with tr-fNIRS. In this study, the investigators will employ a state-of-the-art full head coverage tr-fNIRS device to monitor the entire brain, as opposed to only select regions (such as the limited capabilities of the current cerebral oximeters) in the perioperative setting. Together with in-house analysis algorithms, the full head coverage tr-fNIRS can detect specific brain regions at-risk of ischemic injury with a high degree of certainty because of greater spatial resolution (in cm) and less signal contamination from extracerebral tissue.
All study participants will be recruited and consented adhering to the local ethics guidelines. For all study participants, the surgical and anesthetic management of the patients will be conducted in a standard fashion and will not be altered in this study. The exception is that tr-fNIRS will be used to monitor regional brain oxygenation from anesthesia induction to completion of surgery. The surgeons, anesthesiologists, and nurses will be blinded to the monitor/measurements during the procedure. No intervention will be administered based on the results of the tr-fNIRS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tr-FNIRS neuromonitor | – | Device: multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)During shoulder surgery, the tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) neuromonitor will be used to gather data on cerebral oxygenation of multiple brain regions for these patients. No intervention will be administered based on the results of the tr-fNIRS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Shoulder surgery patients were chosen as the study population because of the high frequency of intraoperative hypotensive and cerebral desaturation events that may occur during this procedure, and the unique physiological changes such as impaired cerebral autoregulation that accompany the beach chair surgical positioning. This unique but commonly encountered operative condition create ischemic challenges and injury to the brain and provide opportunities to assess the spatial and temporal differences of cerebral desaturation patterns experienced during hypotensive and other physiological challenges, and to refine the tr-fNIRS device for perioperative applications.
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years old)
- Scheduled to have elective shoulder surgery in the beach-chair position under general anesthesia
- Provide informed consent
Key exclusion criteria (1 listed)
- have skin/scalp lesions that preclude the application of fNIRS device to the head ii) lack of written consent iii) emergency 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 |
|---|---|---|
| multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)Participants will be monitored during surgery using the multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS). This study is observational in nature and no intervention will be applied based on the results of the tr-fNIRS device. | Device | tr-FNIRS neuromonitor |
Primary outcome
Impact of intraoperative hemodynamic parameter on regional differences in cerebral oxygenation (ScO2) between brain regions during surgery
Time frame: Duration of surgical procedure
cerebral oxygenation (ScO2) between brain regions will be done by assessing the data collected by the tr-fNIRS monitor during surgery.
2 secondary outcomes
Regional differences in cerebral autoregulation in beach-chair position under general anesthesia as measured by the tr-fNIRS monitor (Hz) data outputs.
Time frame: Duration of surgery
To assess the association between cerebral desaturation (or hypoxic injury) events in multiple brain regions to clinical outcomes such as stroke and delirium
Time frame: Up to 72 hours following surgery or until discharge from hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 27440630Mrkobrada M, Hill MD, Chan MT, Sigamani A, Cowan D, Kurz A, Sessler DI, Jacka M, Graham M, Dasgupta M, Dunlop V, Emery DJ, Gulka I, Guyatt G, Heels-Ansdell D, Murkin J, Pettit S, Sahlas DJ, Sharma M, Sharma M, Srinathan S, St John P, Tsai S, Gelb AW, O'Donnell M, Siu D, Chiu PW, Sharath V, George A, Devereaux PJ. Covert stroke after non-cardiac surgery: a prospective cohort study. Br J Anaesth. 2016 Aug;117(2):191-7. doi: 10.1093/bja/aew179.
- Background: PubMed 21478735Mashour GA, Shanks AM, Kheterpal S. Perioperative stroke and associated mortality after noncardiac, nonneurologic surgery. Anesthesiology. 2011 Jun;114(6):1289-96. doi: 10.1097/ALN.0b013e318216e7f4.
- Background: PubMed 31422895NeuroVISION Investigators. Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019 Sep 21;394(10203):1022-1029. doi: 10.1016/S0140-6736(19)31795-7. Epub 2019 Aug 15.
- Background: PubMed 11603436Salazar JD, Wityk RJ, Grega MA, Borowicz LM, Doty JR, Petrofski JA, Baumgartner WA. Stroke after cardiac surgery: short- and long-term outcomes. Ann Thorac Surg. 2001 Oct;72(4):1195-201; discussion 1201-2. doi: 10.1016/s0003-4975(01)02929-0.
- Background: PubMed 20514957McCulloch TJ, Liyanagama K, Petchell J. Relative hypotension in the beach-chair position: effects on middle cerebral artery blood velocity. Anaesth Intensive Care. 2010 May;38(3):486-91. doi: 10.1177/0310057X1003800312.
- Background: PubMed 20508134Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
- Background: PubMed 23415820Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15.
- Background: PubMed 21620637Lee JH, Min KT, Chun YM, Kim EJ, Choi SH. Effects of beach-chair position and induced hypotension on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery. Arthroscopy. 2011 Jul;27(7):889-94. doi: 10.1016/j.arthro.2011.02.027. Epub 2011 May 28.
- Background: PubMed 29889106Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.
- Background: PubMed 22104067Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.
- Background: PubMed 22661748Ono M, Joshi B, Brady K, Easley RB, Zheng Y, Brown C, Baumgartner W, Hogue CW. Risks for impaired cerebral autoregulation during cardiopulmonary bypass and postoperative stroke. Br J Anaesth. 2012 Sep;109(3):391-8. doi: 10.1093/bja/aes148. Epub 2012 Jun 1.
- Background: PubMed 31644437Brady KM, Hudson A, Hood R, DeCaria B, Lewis C, Hogue CW. Personalizing the Definition of Hypotension to Protect the Brain. Anesthesiology. 2020 Jan;132(1):170-179. doi: 10.1097/ALN.0000000000003005. No abstract available.
- Individual participant dataSharing planned: No
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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.
Jason Chui principal investigator
Western 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 Stroke and Cerebral Oxygenation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 1 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 1 Mar 2024. 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 Jason Chui (5196858500 ext. 34435, Jason.Chui@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of intraoperative hemodynamic parameter on regional differences in cerebral oxygenation (ScO2) between brain regions during surgery (time frame: Duration of surgical procedure). 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 NCT05752981, which also lists 20 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 1 Mar 2024.