Trial · NCT02241655
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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 |
| Other | One-year All-cause Mortality (Stratified by Treatment Arm and Delirium Status) | 1 year | Death from any cause within one year (stratified by treatment arm and delirium status) |
| Other | 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. |
| Other | 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). |
| Other | EEG and Delirium | 5 days | A subset of patients underwent postoperative EEG with a limited montage (F8, O2, Cz electrodes) in the resting eyes open and eyes closed states concurrently with the delirium assessments on postoperative days 1-5. Frontal and occipital relative spectral power in three frequency bands (delta = 1-4 Hz, theta = 4-8 Hz, alpha = 8-13 Hz) was calculated at each time point. The discriminative ability of each relative spectral power component to detect delirium was quantified using area under the receiver operating characteristic curve (labeled as "probability" below). |
| Other | 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. |
| Other | Falls at One Year | 1 year | Falls were detected via patient report on a survey administered 1 year following surgery. The question defined a fall as "an event in which you lost your balance and landed on the floor or ground or lower level." |
| Other | ICU Length of Stay | 1 year | Number of calendar days the patient was admitted to the ICU following surgery |
| Other | Hospital Length of Stay | 1 year | Number of calendar days the patient was admitted to the hospital following surgery |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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