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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE) : A Multicenter Randomized Controlled Trial

Conditions
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Delirium, Delirium in Old Age, Critical Illness, Intensive Care Unit Delirium

Intervention / Treatment
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* Device: EyeControl-Pro
* Other: Control


Participation Criteria
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Eligibility Criteria
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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. Have an unstable cervical spine or collar in place limiting movement. 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 Hebrew in Israel) Refusal of treating clinical team.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants will be randomized to either a) EyeControl-Pro assisted active intervention arm or b) sham control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EyeControl-Pro assisted active intervention arm<br>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. | Device: EyeControl-Pro<br>* Based on artificial intelligence (AI)-powered eye-tracking technology, the EyeControl-Pro wearable device and smart platform enable 24/7 customizable communication and monitoring between ventilated patients who cannot speak, their families, and medical teams<br>|
| Sham Comparator: Sham Control<br>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. | Other: Control<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of delirium free assessments as assessed by Confusion Assessment Method (CAM) | 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 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 which provides a binary response delirium present or not. | Upto 7 days or liberation from ventilator whichever is sooner. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium severity as measured by Confusion Assessment Method Intensive Care Unit-7(CAM-ICU7) | To evaluate if study subjects in the active EyeControl-Pro arm have lower delirium severity 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. 0 indicating no delirium to 7 (severe delirium) | Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner | 
| Delirium incidence | 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. The CAM-ICU generates a score of 0-4. 0 being no delirium, 4 being severe. | Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner | 
| ICU days alive and free of delirium and coma | To evaluate if subjects randomized to the active EyeControl-Pro arm have higher number of days free of coma and delirium within first 7 days post randomization or ICU discharge whichever is sooner when compared to sham EyeControl-Pro arm | Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner |