Clinical trial NCT06029244: Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)
Official title: Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE) : A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Delirium in Old Age
Critical Illness
Intensive Care Unit Delirium
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency
name: Rabin Medical Center
name: Assuta Medical Center
name: Eyefree Assisting Communication Ltd
First posted: 2023-09-08
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomized to either a) EyeControl-Pro assisted active intervention arm or b) sham control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Upto 7 days or liberation from ventilator whichever is sooner.
Secondary outcomes:
measure: 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)
timeFrame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
measure: 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.
timeFrame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
Other outcomes:
measure: Cognitive scores
timeFrame: 30 days post-randomization.
measure: Depression anxiety scores
timeFrame: 30 days post-randomization.
measure: CAM ICU concordance
timeFrame: During device usage upto 7 days
measure: Cumulative dose of sedatives
timeFrame: During device usage or upto 7 days whichever is sooner
measure: Days free of restraints
timeFrame: Upto 7 days or discharge from intensive care unit
measure: Use of rescue medications for delirium and agitation
timeFrame: Upto 7 days or discharge from intensive care unit
measure: ICU days alive and free of delirium and coma
timeFrame: Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Somnath Bose, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mart MF, Williams Roberson S, Salas B, Pandharipande PP, Ely EW. Prevention and Management of Delirium in the Intensive Care Unit. Semin Respir Crit Care Med. 2021 Feb;42(1):112-126. doi: 10.1055/s-0040-1710572. Epub 2020 Aug 3.
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