Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)

Not Applicable

Recruiting

• Conditions: Critical Illness; Intensive Care Unit Delirium; Delirium; Delirium in Old Age

• Registration Number: NCT06029244
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 effective in reducing delirium incidence and severity.

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, mechanically ventilated patients aged \>=50 years with Richmond Agitation Sedation Scale (RASS) score of -3 to +1 (at time of screening) who are anticipated to require ventilation for \>=24 hours will be eligible for recruitment. The study will be conducted simultaneously at Beth Israel Deaconess Medical Center (BIDMC) Boston, USA, Assuta Ashdod Medical Center (Ashdod, Israel) and Rabin Medical Center (Petah Tikvah, Israel) with BIDMC contributing up to 50% of the total enrollment. Participants will be randomized to either a) sham device or b) active intervention arm (details described below). Legally appointed representatives, patients and caregiver teams will be administered an optional questionnaire to assess their experience with the study device at the conclusion of the study protocol. Study subjects will be administered the telephone-Montreal Cognitive Assessment (t-MoCA); total score of 22 - missing 8 points present in Montreal Cognitive Assessment (MoCA) pertaining to drawing/executive function not feasible over phone) or MoCA (if still in-hospital; assessed out of total score of 30) and Hospital Anxiety and Depression Scale (HADS) questionnaire 30 days post-randomization. Hebrew versions of these questionnaires will be used at Israeli sites.

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2024-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Mechanically ventilated patients aged >=50 years
• RASS score of -3 to +1 and
• Anticipated to require >=24 hours of mechanical ventilation

Exclusion Criteria

• 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 acute or subacute neurological disorders.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of any delirium ocurrrance defined as CAM ICU 7 score (>=2) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner)	Upto 7 days or liberation from ventilator whichever is sooner.	To evaluate if study subjects randomized to active EyeControl-Pro arm have a higher proportion of delirium free assessments as assessed by CAM (confusion assessment method)-ICU 7 during device usage for up to 7 days when compared with those in the sham EyeControl-Pro arm. CAM-ICU is a validated assessment tool for detection of ICU delirium.

Secondary Outcome Measures

Name	Time	Method
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)	Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner	To evaluate if study subjects in the active EyeControl-Pro arm have lower prevalence of severe delirium assessments as measured by CAM-ICU7 within first 7 days post randomization or ICU discharge (whichever is sooner) when compared to sham control arm. CAM-ICU 7 is a validated instrument for measurement of delirium severity with scores ranging from 0-7.
Mean number of days with delirium (defined as the total number of days with at least one CAM ICU 7 positive delirium assessment within 7 days post-randomization or up to discharge from the ICU/death, whatever occurs earlier.	Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner	To evaluate if subjects randomized to the active EyeControl-Pro arm have lower delirium incidence (as measured by CAM-ICU) within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm.

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Assuta Ashdod Medical Center; 🇮🇱 Ashdod, Israel

Rabin Medical Center; 🇮🇱 Petah tikva, Israel