Your session is about to expire
← Back to Search
EyeControl Communication Device for ICU Delirium (EMERGE Trial)
N/A
Recruiting
Led By Somnath Bose, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mechanically ventilated patients aged >=50 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-randomization.
Awards & highlights
EMERGE Trial Summary
This trial aims to find out if adding a medical platform to care for critically ill patients can reduce delirium and its severity.
Who is the study for?
This trial is for critically ill patients aged 50 or older who are expected to need a ventilator for at least 24 hours and can respond minimally. They shouldn't be in another conflicting study, have severe cognitive impairments, uncorrected hearing or vision issues, or conditions limiting survival or care directives.Check my eligibility
What is being tested?
The EMERGE trial is testing if the EyeControl-Pro platform helps reduce how often and how severely delirium occurs in ICU patients when added to standard care. Patients will either use the new device (EyeControl-Pro) or receive usual care without it.See study design
What are the potential side effects?
Since this trial involves a communication aid rather than medication, traditional side effects aren't expected. However, discomfort from using the device or potential frustration if difficulties arise could occur.
EMERGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years or older and on a mechanical ventilator.
EMERGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post-randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-randomization.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of CAM ICU+ assessments during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)
Secondary outcome measures
Mean number of days with delirium (defined as the total number of days with at least one CAM ICU positive delirium assessment) within 7 days post-randomization or up to discharge from the ICU/death, whatever occurs earlier.
Prevalence of severe delirium assessments (defined as CAM ICU 7>6) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)
Other outcome measures
CAM ICU concordance
Cognitive scores
Cumulative dose of sedatives
+4 moreEMERGE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: EyeControl-Pro assisted active intervention armActive Control1 Intervention
The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Personalized family messages recorded by LARs or others will be played at regular intervals up to 5 times per day (between 08:00-18:00) (8 am to 6 pm). Personalized music/brown noise will be played for 15 minutes every 4 hours, which will be modulated according to your reactions/choices. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.
Group II: Sham ControlPlacebo Group1 Intervention
The device will be placed on patient's heads. Once the device is properly positioned, patient's will undergo a training session/tutorial lasting 2-3 minutes to orient them to the device usage. Patient's will not receive any of the orientation or family messages and no music will be played through the earphones of the device. A study team member will assess patient's mental status by asking thinking and memory questions twice a day (AM and PM). The device will perform the same assessments within 30 minutes of those performed by the study team. The device will be removed at 1800/2000 hrs to ensure adequate sleep. Patient's will be in this study arm for up to 7 days of start of study. The device will be removed on day 7 or sooner if patient's do not need ventilator support and standard care will continue as before device usage.
Find a Location
Who is running the clinical trial?
Assuta Medical CenterOTHER
42 Previous Clinical Trials
44,558 Total Patients Enrolled
Rabin Medical CenterOTHER
413 Previous Clinical Trials
125,859 Total Patients Enrolled
BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agencyUNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for applicants to join this research endeavor?
"According to clinicaltrials.gov, this medical research is not currently accepting patients. The study was first announced on October 1st 2023 and last updated on September 12th 2023. However, there are 277 other trials that are presently enrolling participants at the moment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger