Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05752981
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-02-02
Brief Title:
Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Prevention of Perioperative Brain Injury
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Full-head Coverage Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Early Detection and Prevention of Perioperative Brain Injury
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 CAbetween 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 andor 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 ie 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 monitormeasurements during the procedure No intervention will be administered based on the results of the tr-fNIRS
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 ie 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 monitormeasurements during the procedure No intervention will be administered based on the results of the tr-fNIRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None