Delirium
Conditions
Keywords
Anesthesia, Electroencephalography, Burst suppression, Surgery, Delirium, Falls, Health related quality of life
Brief summary
This study aims to determine whether, compared with usual anesthetic care, an electroencephalography-guided anesthesia protocol is effective at preventing postoperative delirium and its downstream effects, and improving postoperative patient reported health-related quality of life.
Detailed description
Delirium is one of several geriatric syndromes, and is among the most common postoperative complications, affecting up to 70% of surgical patients older than 60. Delirium is an acute change that manifests as inattention and inability to think logically, and is deeply distressing to patients and their families. Based on our surveys of 1,000 surgical patients, over 30% were worried about experiencing delirium. Delirious patients are unable to participate effectively in rehabilitation exercises and are susceptible to other geriatric syndromes, like falls. The occurrence and duration of delirium are associated with longer intensive care unit and hospital stay, persistent cognitive deterioration, hospital readmission and increased mortality rate. Additionally, delirium carries a huge social and economic burden, costing over $60,000 per patient per year. Despite the importance of delirium to patients and to society, no approach has been proven to prevent postoperative delirium. Furthermore postoperative delirium is frequently unrecognized, and surgical patients are not followed systematically after they are discharged from hospital. Without diagnosing delirium or following patients postoperatively, we are limited in our ability to test the effectiveness of any intervention to prevent or treat postoperative delirium and its sequelae. There is mounting evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium. Specifically, our group has found that a suppressed electroencephalogram pattern, which occurs with deep anesthesia, is associated with increased delirium and death after surgery. The Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study will therefore compare the effectiveness of two anesthetic protocols for reduction of postoperative delirium. One protocol will be based on current standard anesthetic practice, and the other protocol will be based on electroencephalography guidance. We also expect to determine the impact of the anesthetic protocols on patient reported outcomes of health-related quality of life. At Washington University, we have successfully implemented an ambitious study that enrolls patients at the preoperative assessment clinic, and tracks their health and wellbeing at 30 days and at 1-year postoperatively. This will enable us to assess the consequences of postoperative delirium and to determine whether anesthetic management can impact patient reported outcomes, such as health-related quality of life. We shall also explore whether a multi-component safety intervention for delirious patients prevents downstream adverse events, like falls. The ENGAGES study - through its structured anesthesia protocols, its thorough approach to delirium assessment, and its ability to track patients' health and wellbeing postoperatively - is poised to make a major contribution to the care of elderly patients who are at risk of postoperative delirium and other adverse outcomes.
Interventions
DEVICEa pragmatic EEG-guided anesthetic protocol
Sponsors
National Institute on Aging (NIA)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Patients 60 years old and older, * Competent to provide informed consent * Undergoing major elective surgery that requires a minimum stay of 2 days postoperatively (e.g., open cardiac surgery, open thoracic surgery, major vascular surgery, intra-abdominal surgery, open gynecologic surgery, open urologic surgery, major orthopedic surgery, open hepato-biliary surgery and major ear, nose and throat surgery) Exclusions * Neurosurgical procedures will be excluded as surgery on the brain can confound the outcome (postoperative delirium). * Patients with preoperative delirium and patients who are unable to participate adequately in delirium screening including those who are blind, deaf, or illiterate or fluent in languages other than English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Delirium | 5 days | Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Falls | Up to 1 year postoperatively | The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls. |
| Health Related Quality of Life | Up to one year postoperatively | The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically Relevant Outcomes Associated With Delirium | 1 year | Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline. |
| Comparison of Patient-reported and Observational Pain Scores | 5 days | Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients. |
| Postoperative Actigraphy | 1 day | Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement. |
| Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments | 5 days | Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis. |
| Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth | 1 year | There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study. |
| Duration of Delirium | 5 days | Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews. |
| Collaborations With Other Studies | 5 years | The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites. |
| Number of Participants With Severe Delirium | 5 days | The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19). |
| EEG and Delirium | 5 days | EEG abnormalities have previously been associated with postoperative delirium |
| Postoperative Actigraphy- Immobile Minutes | 1 day | Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile. |
| Delirium Prediction Models | 5 days | It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group. |
| Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions | 5 days | The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients. |
| Duration or Recurrence of Delirium After Hospital Discharge | 30 days post discharge | As measured by the FAM-CAM and patient perceptions |
Countries
United States
Participant flow
Pre-assignment details
1400 participants were consented to the study168 were not randomized to a study treatment arm (2 died, 49 were ineligible after enrollment, 49 surgery was cancelled, 31 research team missed the surgery, 37 withdrew). A total of 1232 patients were randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| EEG Guided Protocol Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol | 614 |
| Control Arm Participants will have the standard anesthetic protocol. | 618 |
| Total | 1,232 |
Baseline characteristics
| Characteristic | Total | EEG Guided Protocol | Control Arm |
|---|---|---|---|
| 8-item Inerview-Differentiate Aging and Dementia (AD8) | 0.0 units on a scale | 0 units on a scale | 0 units on a scale |
| Age, Continuous | 69.5 years | 69.5 years | 69.4 years |
| Aortic stenosis | 198 Participants | 90 Participants | 108 Participants |
| Attended College | 406 Participants | 198 Participants | 208 Participants |
| Barthel Activies of Daily Living | 15 units on a scale | 15 units on a scale | 15 units on a scale |
| BMI | 29.0 kg/m^2 | 29.0 kg/m^2 | 29.0 kg/m^2 |
| Current use of anticonvulsants | 175 Participants | 94 Participants | 81 Participants |
| Hand grip strength | 26.1 kg STANDARD_DEVIATION 10.9 | 26.4 kg STANDARD_DEVIATION 11 | 25.7 kg STANDARD_DEVIATION 10.7 |
| History of delirium | 157 Participants | 78 Participants | 79 Participants |
| History of depression | 168 Participants | 85 Participants | 83 Participants |
| History or high risk OSA | 449 Participants | 230 Participants | 219 Participants |
| Lawton Instrumental Activities of Daily Living | 8 units on a scale | 8 units on a scale | 8 units on a scale |
| Lifetime tobacco use | 725 Participants | 376 Participants | 349 Participants |
| Marginal exercise tolerance (METs) less than 4 | 592 Participants | 297 Participants | 295 Participants |
| Mental VR-12 score | 53.6 Mental Score STANDARD_DEVIATION 10.8 | 53.6 Mental Score STANDARD_DEVIATION 10.6 | 53.6 Mental Score STANDARD_DEVIATION 11 |
| Number of comorbidities | 5 Number of comorbidities | 5 Number of comorbidities | 5 Number of comorbidities |
| Number of participants with American Society of Anesthesiologist Classification greater than 3 | 430 Participants | 209 Participants | 221 Participants |
| Number of Participants with a Weekly Alcohol Intake | 586 Participants | 289 Participants | 297 Participants |
| Personal Health Questionnaire Depression Scale (PHQ-8) | 3.0 units on a scale | 3 units on a scale | 3 units on a scale |
| Physical Veterans Rand 12 Item Health Survey (VR-12) Score | 38.1 Physical Score STANDARD_DEVIATION 11.8 | 38.1 Physical Score STANDARD_DEVIATION 11.9 | 38.2 Physical Score STANDARD_DEVIATION 11.8 |
| Pulmonary hypertension | 192 Participants | 97 Participants | 95 Participants |
| Race/Ethnicity, Customized Black | 107 participants | 54 participants | 53 participants |
| Race/Ethnicity, Customized Other | 12 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized White | 1113 participants | 555 participants | 558 participants |
| Region of Enrollment United States | 1232 Participants | 614 Participants | 618 Participants |
| Regular use of benzodiazepine | 188 Participants | 86 Participants | 102 Participants |
| Regular use of opioids | 303 Participants | 154 Participants | 149 Participants |
| Sex: Female, Male Female | 563 Participants | 282 Participants | 281 Participants |
| Sex: Female, Male Male | 669 Participants | 332 Participants | 337 Participants |
| Short Blessed Test (SBT) | 2.0 units on a scale | 2 units on a scale | 2 units on a scale |
| Timed up and go | 10.8 seconds | 10.5 seconds | 11.0 seconds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 614 | 20 / 618 |
| other Total, other adverse events | 361 / 614 | 345 / 618 |
| serious Total, serious adverse events | 124 / 614 | 130 / 618 |
Outcome results
Primary
Number of Participants With Delirium
Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.
Time frame: 5 days
Population: A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided Protocol | Number of Participants With Delirium | 157 Participants |
| Control Arm | Number of Participants With Delirium | 140 Participants |
Secondary
Health Related Quality of Life
The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year).
Time frame: Up to one year postoperatively
Secondary
Postoperative Falls
The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls.
Time frame: Up to 1 year postoperatively
Other Pre-specified
Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions
The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.
Time frame: 5 days
Other Pre-specified
Clinically Relevant Outcomes Associated With Delirium
Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline.
Time frame: 1 year
Other Pre-specified
Collaborations With Other Studies
The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites.
Time frame: 5 years
Other Pre-specified
Comparison of Patient-reported and Observational Pain Scores
Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients.
Time frame: 5 days
Other Pre-specified
Delirium Prediction Models
It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.
Time frame: 5 days
Population: Covariated included were pre-selected and considered likely to be associated with postoperative delirium.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EEG Guided Protocol | Delirium Prediction Models | Guided Group | 1.12 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Age | 1.04 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Male | 0.99 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | White | 0.46 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Living alone | 0.91 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Hearing aid use | 0.82 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | No. Comorbidities | 1.08 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | ASA greater than 3 | 1.98 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Marginal exercise tolerance less than 4 METS | 1.21 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Falls in previous 6 months | 1.25 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | History of delirium | 1.83 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative PHQ8 | 1.03 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative Lawton | 0.95 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative Barthel | 0.95 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative opioids | 1.27 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative benzodiazepines | 1.28 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative sodium level | 0.98 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative creatinine level | 1.06 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Preoperative hemoglobin level | 0.99 odds ratio |
| EEG Guided Protocol | Delirium Prediction Models | Cardiac surgery | 0.92 odds ratio |
Other Pre-specified
Duration of Delirium
Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.
Time frame: 5 days
Population: A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EEG Guided Protocol | Duration of Delirium | 1 days |
| Control Arm | Duration of Delirium | 1 days |
Other Pre-specified
Duration or Recurrence of Delirium After Hospital Discharge
As measured by the FAM-CAM and patient perceptions
Time frame: 30 days post discharge
Other Pre-specified
EEG and Delirium
EEG abnormalities have previously been associated with postoperative delirium
Time frame: 5 days
Other Pre-specified
Number of Participants With Severe Delirium
The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).
Time frame: 5 days
Population: A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EEG Guided Protocol | Number of Participants With Severe Delirium | 59 Participants |
| Control Arm | Number of Participants With Severe Delirium | 51 Participants |
Other Pre-specified
Postoperative Actigraphy
Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.
Time frame: 1 day
Population: A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EEG Guided Protocol | Postoperative Actigraphy | 134 minutes RMSactivity>0 |
| Control Arm | Postoperative Actigraphy | 101 minutes RMSactivity>0 |
| Delirium POD 2-5 | Postoperative Actigraphy | 93 minutes RMSactivity>0 |
Other Pre-specified
Postoperative Actigraphy- Immobile Minutes
Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.
Time frame: 1 day
Population: A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EEG Guided Protocol | Postoperative Actigraphy- Immobile Minutes | 548 minutes RMSactivity=0 |
| Control Arm | Postoperative Actigraphy- Immobile Minutes | 584 minutes RMSactivity=0 |
| Delirium POD 2-5 | Postoperative Actigraphy- Immobile Minutes | 604 minutes RMSactivity=0 |
Other Pre-specified
Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth
There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study.
Time frame: 1 year
Other Pre-specified
Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments
Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.
Time frame: 5 days
Population: Patients who were in the ICU, had a nursing CAM-ICU assessment and researcher's delirium assessment were included in this analysis. Agreement between the instruments was calculated using Kappa agreement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EEG Guided Protocol | Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments | 0.37 Cohen's kappa coefficient |