Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512989
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2020-08-05
Brief Title:
Use of Electrophysiological Markers to Predict Post-operative Cognitive Dysfunction
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Assessing Brain Frailty The Association Between Pre Intra and Post-operative Electrophysiological Markers and Postoperative Cognitive Dysfunction
Status:
RECRUITING
Status Verified Date:
2023-12
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:
As the population ages and medical progress is made many elderly patients that previously would not have been candidates for surgery are now undergoing operations In this group of older patients brain dysfunction after anesthesia and surgery naming post-operative cognitive dysfunction is well known
Post-operative cognitive dysfunction POCD is a term used to describe subtle changes in cognition such as memory and executive function The most commonly seen problems are memory impairment and impaired performance on intellectual tasks In severe cases it can lead to inability to perform daily living functions It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with increased mortality The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear The risk factors are related to patient characteristics type of operation and anesthetic management
The investigators have recently shown that using different electrophysiological markers they can monitor attention and perception which might be associated with brain frailty and brain injury
The aims of this proof of concept study are i to find-out whether attention processes might be in association with brain frailty ii to find our whether brain injury which is expressed by interhemispheric synchronization is is associated with POCD iii to find out whether the level of anesthesia as measured electrophysiological by perception might be linked primary to POCD
Post-operative cognitive dysfunction POCD is a term used to describe subtle changes in cognition such as memory and executive function The most commonly seen problems are memory impairment and impaired performance on intellectual tasks In severe cases it can lead to inability to perform daily living functions It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with increased mortality The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear The risk factors are related to patient characteristics type of operation and anesthetic management
The investigators have recently shown that using different electrophysiological markers they can monitor attention and perception which might be associated with brain frailty and brain injury
The aims of this proof of concept study are i to find-out whether attention processes might be in association with brain frailty ii to find our whether brain injury which is expressed by interhemispheric synchronization is is associated with POCD iii to find out whether the level of anesthesia as measured electrophysiological by perception might be linked primary to POCD
Detailed Description:
As the population ages and medical progress is made many elderly patients that previously would not have been candidates for surgery are now undergoing operations In this group of older patients brain dysfunction after anesthesia and surgery is well recognized naming post-operative cognitive dysfunction
Post-operative cognitive dysfunction POCD is a term used to describe subtle changes in cognition such as memory and executive function The most commonly seen problems are memory impairment and impaired performance on intellectual tasks In severe cases it can lead to inability to perform daily living functions The reported incidence figures for postoperative cognitive dysfunction vary depending on the group of patients studied the definition of POCD used the tests used to establish the diagnosis and their statistical evaluation the timing of testing and the choice of control group The diagnosis of POCD relies on the availability of the neuropsychological tests In a large prospective multicenter cohort study it was found that the presence of cognitive dysfunction 3 months after noncardiac surgery was associated with an increased mortality Furthermore patients with cognitive decline at 1 week had an increased risk of leaving the labor market prematurely and a higher prevalence of time receiving social transfer payments The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear The risk factors for developing POCD are related to patient characteristics type of operation and anesthetic management
Cardiovascular respiratory hepatic and renal insufficiency are all associated with impaired brain performance It is theoretically obvious that an adequate intraoperative oxygen supply for all vital organs is essential if postoperative cerebral dysfunction is to be avoided Casai et al found that brain desaturation rSO2 decrease 75 of baseline occurred in 40 of elderly patients after noncardiac surgery and the cerebral desaturation was linked with a high incidence of POCD A recent systematic review shows that reductions in cerebral oxygen saturation rSO2 during cardiac surgery may indicate CPB cannula malposition particularly during aortic surgery However only weak evidence links low rSO2 during cardiac surgery to POCD
POCD is a well-recognized clinical phenomenon of multifactorial origin emboli hypoperfusion inflammation and patients preoperative cerebral dysfunction Meticulous surgical and anesthesiological techniques are important for preventing complications and keeping the risk of POCD to a minimum
The EEG is an electrophysiological monitoring method used to record electrical activity of the brain including normal and abnormal activity In recent years numerous clinical studies were performed to evaluate whether the use in intraoperative electroencephalography EEG to control the depth of anesthesia has any effect on POCD
Recently it was confirmed that intraoperative neuro-monitoring for depth of anesthesia is associated with a lower incidence of delirium However it is unrelated to the incidence of POCD The most common available monitor for depth of anesthesia is the Bispectral index developed more than 20 years ago The devices output is based on electroencephalographic EEG signals from the frontal lobe monitors brain activity in combination with electromyographic EMG waves monitors muscle activity The BIS produces a number ranging from 0 -100 which matches the patients level of consciousness awake sedated or unconscious under GA
Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with POD but not with POCD Therefore it is hopeful that an even more precise evaluation of the level of anesthesia will improve POD prediction and thereby prevention even further On the other hand the measure of depth of anesthesia by itself does not provide sufficient prediction for POCD
The investigators have recently that brain injury is demonstrated by interhemispheric desynchronization which is recognized by our new algorithm which monitors electrophysiological markers of attention and of perception This algorithm was based on a previous set of studies which showed the ability to decompose the entire multi-electrode EEG ERP sample to a superposition of attention and perception processes spread in space over the scalp and time hundreds of milliseconds Our algorithm is unique in the ability to extract the needed perceptual and attentional information indicating depth of anesthesia and hemispheric damage manifested by interhemispheric desynchronization in real time every 30 seconds and with a minimal electrodes setup
The aims of this proof of concept study are i to find-out whether attention processes might be in association with brain frailty ii to find our whether brain injury which is expressed by interhemispheric synchronization is is associated with POCD iii to find out whether the level of anesthesia as measured electrophysiological by perception might be linked primary to POCD
Post-operative cognitive dysfunction POCD is a term used to describe subtle changes in cognition such as memory and executive function The most commonly seen problems are memory impairment and impaired performance on intellectual tasks In severe cases it can lead to inability to perform daily living functions The reported incidence figures for postoperative cognitive dysfunction vary depending on the group of patients studied the definition of POCD used the tests used to establish the diagnosis and their statistical evaluation the timing of testing and the choice of control group The diagnosis of POCD relies on the availability of the neuropsychological tests In a large prospective multicenter cohort study it was found that the presence of cognitive dysfunction 3 months after noncardiac surgery was associated with an increased mortality Furthermore patients with cognitive decline at 1 week had an increased risk of leaving the labor market prematurely and a higher prevalence of time receiving social transfer payments The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear The risk factors for developing POCD are related to patient characteristics type of operation and anesthetic management
Cardiovascular respiratory hepatic and renal insufficiency are all associated with impaired brain performance It is theoretically obvious that an adequate intraoperative oxygen supply for all vital organs is essential if postoperative cerebral dysfunction is to be avoided Casai et al found that brain desaturation rSO2 decrease 75 of baseline occurred in 40 of elderly patients after noncardiac surgery and the cerebral desaturation was linked with a high incidence of POCD A recent systematic review shows that reductions in cerebral oxygen saturation rSO2 during cardiac surgery may indicate CPB cannula malposition particularly during aortic surgery However only weak evidence links low rSO2 during cardiac surgery to POCD
POCD is a well-recognized clinical phenomenon of multifactorial origin emboli hypoperfusion inflammation and patients preoperative cerebral dysfunction Meticulous surgical and anesthesiological techniques are important for preventing complications and keeping the risk of POCD to a minimum
The EEG is an electrophysiological monitoring method used to record electrical activity of the brain including normal and abnormal activity In recent years numerous clinical studies were performed to evaluate whether the use in intraoperative electroencephalography EEG to control the depth of anesthesia has any effect on POCD
Recently it was confirmed that intraoperative neuro-monitoring for depth of anesthesia is associated with a lower incidence of delirium However it is unrelated to the incidence of POCD The most common available monitor for depth of anesthesia is the Bispectral index developed more than 20 years ago The devices output is based on electroencephalographic EEG signals from the frontal lobe monitors brain activity in combination with electromyographic EMG waves monitors muscle activity The BIS produces a number ranging from 0 -100 which matches the patients level of consciousness awake sedated or unconscious under GA
Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with POD but not with POCD Therefore it is hopeful that an even more precise evaluation of the level of anesthesia will improve POD prediction and thereby prevention even further On the other hand the measure of depth of anesthesia by itself does not provide sufficient prediction for POCD
The investigators have recently that brain injury is demonstrated by interhemispheric desynchronization which is recognized by our new algorithm which monitors electrophysiological markers of attention and of perception This algorithm was based on a previous set of studies which showed the ability to decompose the entire multi-electrode EEG ERP sample to a superposition of attention and perception processes spread in space over the scalp and time hundreds of milliseconds Our algorithm is unique in the ability to extract the needed perceptual and attentional information indicating depth of anesthesia and hemispheric damage manifested by interhemispheric desynchronization in real time every 30 seconds and with a minimal electrodes setup
The aims of this proof of concept study are i to find-out whether attention processes might be in association with brain frailty ii to find our whether brain injury which is expressed by interhemispheric synchronization is is associated with POCD iii to find out whether the level of anesthesia as measured electrophysiological by perception might be linked primary to POCD
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