Trial · NCT02241655
Electroencephalography Guidance of Anesthesia
NCT02241655, Not applicable, Completed, Washington University School of Medicine; results first posted 2019-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Electroencephalography Guidance of Anesthesia. Trials, record NCT02241655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02241655
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Electroencephalography Guidance of Anesthesia
- NCT number
- NCT02241655
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,400 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Delirium
- Interventions
- a pragmatic EEG-guided anesthetic protocol
- First posted
- 2014-09-16
- Last updated
- 2026-10-29
- Results first posted
- 2019-06-18
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | The Number of Participants With 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. |
| Secondary | 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). The 12-item survey results in two summary scores called the Physical Composite Summary and the Mental Composite Summary. Each of these summary scores takes values between 0 and 100, where higher values represent better quality of life. |
| Other | Duration of Delirium | 5 days | Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews. |
| Other | Agreements Between the Family Confusion Assessment Method (FAM-CAM), and Researchers' Delirium Assessments and Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Delirium Chart Reviews | 3 days | Families of some patients in the ENGAGES trial and "The Prevention of Delirium and Complications Associated with Surgical Treatments" study (NCT01690988) completed FAM-CAM assessments in the afternoon. The FAM-CAM results in a binary classification of presence/absence of delirium. All time points between postoperative day 1-3 with concurrent family-completed FAM-CAM assessments and researcher-completed CAM/CAM-ICU assessments were included. Both arms of both trials were included together to minimize the risk of sampling bias due to a low rate of the FAM-CAM surveys returned. Delirium incidence using each assessment tool was quantified. Agreement between the concurrent FAM-CAM assessments and CAM/CAM-ICU assessments was quantified using repeated measures Cohen's kappa. |
| Other | Incidence of Post-discharge Delirium | Postoperative day 30 | Defined as a positive FAM-CAM assessment between hospital discharge and postoperative day 30 |
| Other | Maximum Postoperative Pain (Patient Reported and Observational) | 5 days | Pain was measured daily from postoperative day 1-5 using both patient-report and observational modalities. Patient-reported pain at rest was assessed using the visual analog scale (VAS), with possible scores ranging from 0 to 100 and higher scores indicating worse pain. The maximum VAS score between postoperative days 1-5 is reported here. Observational pain was assessed using the Behavioral Pain Scale (BPS) for intubated patients or the Behavioral Pain Scale - Non-Intubated (BPS-NI) for non-intubated patients. BPS and BPS-NI scores range from 3 to 12, with higher scores indicating worse pain. The maximum BPS or BPS-NI score between postoperative days 1-5 is reported here. |
| Other | 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. |
| Other | 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. |
| Other | One-year All-cause Mortality | 1 year | Death from any cause within one year |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Delirium | 5 days | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Postoperative Falls | Up to 1 year postoperatively | |||
| SECONDARY | Health Related Quality of Life | Up to one year postoperatively | |||
| OTHER_PRE_SPECIFIED | Duration of Delirium | 5 days | 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). | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions | 5 days | |||
| OTHER_PRE_SPECIFIED | Duration or Recurrence of Delirium After Hospital Discharge | 30 days post discharge | |||
| OTHER_PRE_SPECIFIED | Clinically Relevant Outcomes Associated With Delirium | 1 year | |||
| OTHER_PRE_SPECIFIED | Comparison of Patient-reported and Observational Pain Scores | 5 days | |||
| OTHER_PRE_SPECIFIED | Postoperative Actigraphy | 1 day | 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. | minutes RMSactivity>0 | MEDIAN |
| OTHER_PRE_SPECIFIED | Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments | 5 days | 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. | Cohen's kappa coefficient | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Delirium | EEG Guided Protocol | 157 | Participants | ||
| Number of Participants With Delirium | Control Arm | 140 | Participants | ||
| Duration of Delirium | EEG Guided Protocol | 1 | Inter-Quartile Range 1 to 3 | days | |
| Duration of Delirium | Control Arm | 1 | Inter-Quartile Range 1 to 3 | days | |
| Postoperative Actigraphy | No Delirium | 134 | Inter-Quartile Range 59 to 195 | minutes RMSactivity>0 | |
| Postoperative Actigraphy | Delirium POD 0-1 | 101 | Inter-Quartile Range 50 to 141 | minutes RMSactivity>0 | |
| Postoperative Actigraphy | Delirium POD 2-5 | 93 | Inter-Quartile Range 36 to 236 | minutes RMSactivity>0 | |
| Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments | Patients With Nursing ICU Assessment | 0.37 | 95% Confidence Interval 0.29 to 0.44 | Cohen's kappa coefficient | |
| Delirium Prediction Models | Regression Analysis | Guided Group | 1.12 | 95% Confidence Interval 0.30 to 1.64 | odds ratio |
| Delirium Prediction Models | Regression Analysis | Age | 1.04 | 95% Confidence Interval 1.02 to 1.06 | odds ratio |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EEG Guided Protocol | 614 | |
| Overall Study | STARTED | Control Arm | 618 | |
| Overall Study | COMPLETED | EEG Guided Protocol | 614 | |
| Overall Study | COMPLETED | Control Arm | 618 | |
| Overall Study | NOT COMPLETED | EEG Guided Protocol | 0 | |
| Overall Study | NOT COMPLETED | Control Arm | 0 |
Source ClinicalTrials.gov
Adverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bleeding/anemia requiring unexpected transfusion | Blood and lymphatic system disorders | EEG Guided Protocol | 121 | 614 | |
| other | Bleeding/anemia requiring unexpected transfusion | Blood and lymphatic system disorders | Control Arm | 126 | 618 | |
| other | Embolus | Blood and lymphatic system disorders | EEG Guided Protocol | 0 | 614 | |
| other | Embolus | Blood and lymphatic system disorders | Control Arm | 1 | 618 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | EEG Guided Protocol | 24 | 614 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Control Arm | 23 | 618 | |
| other | Thrombosis without embolus | Blood and lymphatic system disorders | EEG Guided Protocol | 15 | 614 | |
| other | Thrombosis without embolus | Blood and lymphatic system disorders | Control Arm | 12 | 618 | |
| other | Other hematologic event | Blood and lymphatic system disorders | EEG Guided Protocol | 2 | 614 | |
| other | Other hematologic event | Blood and lymphatic system disorders | Control Arm | 1 | 618 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EEG Guided Protocol | 4 | 614 |
| Total, all-cause mortality | Control Arm | 20 | 618 |
| Total, other adverse events | EEG Guided Protocol | 361 | 614 |
| Total, other adverse events | Control Arm | 345 | 618 |
| Total, serious adverse events | EEG Guided Protocol | 124 | 614 |
| Total, serious adverse events | Control Arm | 130 | 618 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH2AG050312 | Electroencephalograph Guidance of Anesthesia to Alleviate Geriatric Syndromes (EN | AVIDAN, MICHAEL SIMON | WASHINGTON UNIVERSITY | NATIONAL INSTITUTE ON AGING | 2014 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EEG Guided Protocol vs Control Arm: Number of Participants With Delirium | Trial comparisons |
| EEG Guided Protocol vs Control Arm: Number of Participants With Severe Delirium | Trial comparisons |
| EEG Guided Protocol vs Control Arm: deaths from any cause | Trial comparisons |
| EEG Guided Protocol vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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