Using EyeControl-Pro to manage delirium in ICU patients
Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE) : A Multicenter Randomized Controlled Trial
This study is testing if the EyeControl-Pro device can help reduce confusion and anxiety in older patients on ventilators in the ICU compared to a dummy device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT06029244 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of the EyeControl-Pro platform as an adjunct to standard care in reducing the incidence and severity of delirium among critically ill patients in intensive care units. The study is a prospective, binational, single-blind, multicenter, randomized control trial involving mechanically ventilated patients aged 50 and older. Participants will be randomized to receive either the active EyeControl-Pro intervention or a sham device, and their cognitive function and anxiety levels will be assessed post-randomization. The trial is conducted at multiple sites, including Beth Israel Deaconess Medical Center in Boston and two medical centers in Israel.
Who should consider this trial
Good fit: Ideal candidates are mechanically ventilated patients aged 50 years and older who are expected to require ventilation for at least 24 hours.
Not a fit: Patients who are not expected to survive for 24 hours or have severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce delirium in critically ill patients, improving their overall recovery and quality of life.
How similar studies have performed: Other studies have shown promise in using technology to manage delirium, but this specific approach with EyeControl-Pro is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Assuta Ashdod Medical Center — Ashdod, Israel (Not_yet_recruiting)
- Rabin Medical Center — Petah tikva, Israel (Not_yet_recruiting)
Study contacts
- Principal investigator: Somnath Bose, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Alkanada Behera
- Email: abehera@bidmc.harvard.edu
- Phone: 617-667-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.