Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783662
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2021-03-02
Brief Title:
Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Study of an Intraoperative Frontal Electroencephalographic Marker of Preoperative Frailty in Patients Over 65 Years of Age for Elective Non-cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2021-01
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:
Frailty is a state of vulnerability characterized by a loss of mechanisms that maintain homeostasis determining a lower capacity for recovery in the event of a stressful incident It is one of the risk factors that increase postoperative adverse outcomes in the elderly population It has been associated with worse results in different surgical settings including increased mortality readmission referral to specialized care units increased costs and hospital stay Currently there are several instruments for diagnosis and screening of frailty All of them require time for their execution an experienced evaluator and an adequate validation in the population in which they are intended to be used The use of frontal electroencephalography during the intraoperative period has become increasingly popular It allows the monitoring of brain activity during the administration of anesthetics Various intraoperative electroencephalographic markers such as alpha spectral power or total spectrum power have been associated with factors such as preoperative physical activity preoperative cognitive level comorbidities and postoperative delirium The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in 65 years patients undergoing general anesthesia with Sevoflurane for non-cardiac surgery
Detailed Description:
The world health organization has estimated that the population over 60 years of age will increase exponentially between 2015 and 2050 This change will be more pronounced in developing countries including Chile Each year the number of older people 65 years undergoing surgical interventions raises This is due to a sustained increase in life expectancy demographic changes and progress in surgicalanesthetic techniques that allow this population to undergo less invasive procedures In addition older patients have a higher risk of postoperative morbidity and mortality compared to younger people
Frailty is one of the risk factors that increase adverse postoperative outcomes in the elderly population It is defined as a state of vulnerability or lack of physiological reserve that is characterized by an inadequate resolution of homeostasis after a stressful event Frailty determines that an event can generate changes in the postoperative state of dependence of these patients causing a person who was independent prior to surgery to end up requiring assistance with their activities of daily living after it Frailty has been associated with worse outcomes in different surgical settings including increased mortality readmission referral to specialized care units increased costs and hospital stay In addition preoperative frailty has also been associated with postoperative delirium
Currently there are several instruments for the diagnosis and screening of frailty that present good sensitivity and specificity All of them require time for their execution an experienced evaluator and adequate validation in the population in which they are intended to be used Furthermore with some instruments specific elements may be required for example the Handgrip dynamometer for the Fried phenotype These conditions are not always easy to obtain in the local preoperative setting and the tools are not always adequately validated for non-English speaking populations Moreover there is uncertainty regarding which frailty instrument to choose among the dozens described in the literature and there are time pressures that prevent the addition of more tests or evaluations in the preoperative clinic
The use of frontal electroencephalography EEG during the intraoperative period has become increasingly popular It is used to obtain a real-time record of brain electrical activity during administration of anesthetics Interpreting the EEG in the time domain in real time in the operation room is challenging Therefore various processed EEG monitors BIS SedLine currently clinically used have incorporated the spectral analysis to their records The spectrum presents the advantage to show the frequency decomposition of the EEG segment for all frequencies in a given range usually 30 Hz by plotting the frequency on the X axis and power on the Y axis The accumulation of spectra over time is called spectrogram and can be presented graphically on the monitor where the X-axis represents time Y axis the decomposition of frequencies and the Z bar represents the amplitude or power of the different waves With increasing age there is a decrease in spectral power and alpha wave coherence 8-12 Hz In addition decreased alpha spectral power during anesthetic administration has been correlated with preoperative cognitive dysfunction Recently preoperative physical activity the spectral power of the alpha wave and the entire spectral band have been associated with postoperative delirium in the cardio-surgical population In addition the spectral power of the alpha wave and broadband power baseline noise has been correlated with changes in age and patient comorbidities
The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in a population older than 65 years undergoing general anesthesia with sevoflurane for elective non-cardiac surgery Our hypothesis is that frail patients determined by the FRAIL Clinical Frailty Scale and Fried scales undergoing general anesthesia with sevofluorane for non-cardiac surgery have a lower alpha spectral power and lower entire spectral band power of the EEG compared to patients of similar age who are robust undergoing the same type of surgeries
Frailty is one of the risk factors that increase adverse postoperative outcomes in the elderly population It is defined as a state of vulnerability or lack of physiological reserve that is characterized by an inadequate resolution of homeostasis after a stressful event Frailty determines that an event can generate changes in the postoperative state of dependence of these patients causing a person who was independent prior to surgery to end up requiring assistance with their activities of daily living after it Frailty has been associated with worse outcomes in different surgical settings including increased mortality readmission referral to specialized care units increased costs and hospital stay In addition preoperative frailty has also been associated with postoperative delirium
Currently there are several instruments for the diagnosis and screening of frailty that present good sensitivity and specificity All of them require time for their execution an experienced evaluator and adequate validation in the population in which they are intended to be used Furthermore with some instruments specific elements may be required for example the Handgrip dynamometer for the Fried phenotype These conditions are not always easy to obtain in the local preoperative setting and the tools are not always adequately validated for non-English speaking populations Moreover there is uncertainty regarding which frailty instrument to choose among the dozens described in the literature and there are time pressures that prevent the addition of more tests or evaluations in the preoperative clinic
The use of frontal electroencephalography EEG during the intraoperative period has become increasingly popular It is used to obtain a real-time record of brain electrical activity during administration of anesthetics Interpreting the EEG in the time domain in real time in the operation room is challenging Therefore various processed EEG monitors BIS SedLine currently clinically used have incorporated the spectral analysis to their records The spectrum presents the advantage to show the frequency decomposition of the EEG segment for all frequencies in a given range usually 30 Hz by plotting the frequency on the X axis and power on the Y axis The accumulation of spectra over time is called spectrogram and can be presented graphically on the monitor where the X-axis represents time Y axis the decomposition of frequencies and the Z bar represents the amplitude or power of the different waves With increasing age there is a decrease in spectral power and alpha wave coherence 8-12 Hz In addition decreased alpha spectral power during anesthetic administration has been correlated with preoperative cognitive dysfunction Recently preoperative physical activity the spectral power of the alpha wave and the entire spectral band have been associated with postoperative delirium in the cardio-surgical population In addition the spectral power of the alpha wave and broadband power baseline noise has been correlated with changes in age and patient comorbidities
The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in a population older than 65 years undergoing general anesthesia with sevoflurane for elective non-cardiac surgery Our hypothesis is that frail patients determined by the FRAIL Clinical Frailty Scale and Fried scales undergoing general anesthesia with sevofluorane for non-cardiac surgery have a lower alpha spectral power and lower entire spectral band power of the EEG compared to patients of similar age who are robust undergoing the same type of surgeries
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