Overview
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.
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
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.