Critical Illness, Delirium, Delirium in Old Age, Intensive Care Unit Delirium
Conditions
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.
Interventions
DEVICEEyeControl-Pro
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
OTHERControl
No intervention
Sponsors
BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency
Rabin Medical Center
Assuta Medical Center
Eyefree Assisting Communication Ltd
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients will be unblinded, or unmasked, to treatment allocation given the nature of the intervention.
Intervention model description
Study participants will be randomized to either a) EyeControl-Pro assisted active intervention arm or b) sham control
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of any delirium occurrence defined as CAM ICU 7 score (>=2) during the first 7 days in ICU post-randomization or ICU discharge/death (whichever is sooner) | Upto 7 days or liberation from ventilator whichever is sooner. | 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 7 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner | 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. |
| 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) | Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner | To evaluate if study subjects in the active EyeControl-Pro arm have lower prevalence of severe delirium assessments 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| CAM ICU concordance | During device usage upto 7 days | Agreement between CAM ICU assessment between Eyecontrol and investigator administered CAM-ICU in active intervention arm |
| Days free of restraints | Upto 7 days or discharge from intensive care unit | Comparison of days free of restraints between 2 groups |
| Use of rescue medications for delirium and agitation | Upto 7 days or discharge from intensive care unit | Use of medications for agitated delirium |
| ICU days alive and free of delirium and coma | Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner | 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 |
| Cognitive scores | 30 days post-randomization. | To compare cognitive function at 30 days post enrollment using the t-MoCA (telephone-Montreal Cognitive Assessment) or MoCA (if still in-hospital) questionnaire. MoCA is a validated instrument for assessment of cognition with range 0-30 (0-22 for telephonic version) score of over 26 indicates normal. |
| Depression anxiety scores | 30 days post-randomization. | To compare depression and anxiety scores at 30 days post enrollment using the HADS (Hospital Anxiety and Depression Scale) questionnaire.HADS ranges from 0-21 with higher scores indicating worse depression or anxiety |
Countries
Israel, United States
Outcome results
None listed