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

Beth Israel Lahey Health

Status: Enrolling

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

Treatments: Device: EyeControl-Pro; Other: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06029244

2023P000563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

EyeControl-Pro assisted active intervention arm

Active Comparator group

Description:

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.

Treatment:

Device: EyeControl-Pro

Sham Control

Sham Comparator group

Description:

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.

Treatment:

Other: Control