Status:
COMPLETED
Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency
Rabin Medical Center
Conditions:
Delirium
Delirium in Old Age
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The purpose of this research is to investigate whether addition of the EyeControl-Pro platform as an adjunct to standard guideline-based intensive care unit management of critically ill patients is ef...
Detailed Description
This is a prospective, binational, single-blind, multicenter, randomized control trial, conducted according to international good clinical practice (GCP) ethical and quality standards. Critically ill,...
Eligibility Criteria
Inclusion
- Mechanically ventilated patients aged \>=50 years
- RASS score of -3 to +1 and
- Anticipated to require \>=24 hours of mechanical ventilation
Exclusion
- Not expected to survive \>=24 hours
- Have limitations in care (Do Not Resuscitate, or comfort-focused care orders)
- Receiving paralytic neuromuscular blocking agent (NMBA) infusion or anticipated need for NMBA use
- Have advanced dementia or cognitive impairment including post-concussive syndrome.
- Have severe uncorrected psychiatric disorders.
- Have uncorrected hearing or visual impairment.
- Acute or subacute neurological disorder hindering communication or ability to participate in CAM ICU assessments
- Enrolled in a clinical trial which prohibits co-enrollment.
- Incarcerated
- Have no identified legally appointed representative (LAR)
- Are unable to communicate in the predominant local language (English at US site and English/Hebrew/Arabic/Russian in Israel)
- Refusal of treating clinical team.
Key Trial Info
Start Date :
February 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06029244
Start Date
February 25 2024
End Date
November 18 2025
Last Update
December 3 2025
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Assuta Ashdod Medical Center
Ashdod, Israel
3
Rabin Medical Center
Petah Tikva, Israel