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

Critical Illness Clinical Trial

— EMERGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029244
• Other study ID #: 2023P000563
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Alkanada Behera
• Phone: 617-667-7000
• Email: abehera[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

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.

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Delirium in Old Age
• Intensive Care Unit Delirium

Intervention

Device:
• EyeControl-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

Other:
• Control
No intervention

Locations

Country	Name	City	State
Israel	Assuta Ashdod Medical Center	Ashdod
Israel	Rabin Medical Center	Petah tikva
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Assuta Medical Center, BIRD (Israel-United States Binational Industrial Research and Development) Foundation- Funding agency, Eyefree Assisting Communication Ltd, Rabin Medical Center

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (12)

Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8. — View Citation

Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753. — View Citation

Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14. — View Citation

Hayhurst CJ, Pandharipande PP, Hughes CG. Intensive Care Unit Delirium: A Review of Diagnosis, Prevention, and Treatment. Anesthesiology. 2016 Dec;125(6):1229-1241. doi: 10.1097/ALN.0000000000001378. — View Citation

Kinchin I, Mitchell E, Agar M, Trepel D. The economic cost of delirium: A systematic review and quality assessment. Alzheimers Dement. 2021 Jun;17(6):1026-1041. doi: 10.1002/alz.12262. Epub 2021 Jan 21. — View Citation

Mart MF, Williams Roberson S, Salas B, Pandharipande PP, Ely EW. Prevention and Management of Delirium in the Intensive Care Unit. Semin Respir Crit Care Med. 2021 Feb;42(1):112-126. doi: 10.1055/s-0040-1710572. Epub 2020 Aug 3. — View Citation

Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92. — View Citation

Neufeld KJ, Yue J, Robinson TN, Inouye SK, Needham DM. Antipsychotic Medication for Prevention and Treatment of Delirium in Hospitalized Adults: A Systematic Review and Meta-Analysis. J Am Geriatr Soc. 2016 Apr;64(4):705-14. doi: 10.1111/jgs.14076. Epub 2016 Mar 23. Erratum In: J Am Geriatr Soc. 2016 Oct;64(10 ):2171-2173. — View Citation

Nikooie R, Neufeld KJ, Oh ES, Wilson LM, Zhang A, Robinson KA, Needham DM. Antipsychotics for Treating Delirium in Hospitalized Adults: A Systematic Review. Ann Intern Med. 2019 Oct 1;171(7):485-495. doi: 10.7326/M19-1860. Epub 2019 Sep 3. — View Citation

Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372. — View Citation

Pun BT, Badenes R, Heras La Calle G, Orun OM, Chen W, Raman R, Simpson BK, Wilson-Linville S, Hinojal Olmedillo B, Vallejo de la Cueva A, van der Jagt M, Navarro Casado R, Leal Sanz P, Orhun G, Ferrer Gomez C, Nunez Vazquez K, Pineiro Otero P, Taccone FS, Gallego Curto E, Caricato A, Woien H, Lacave G, O'Neal HR Jr, Peterson SJ, Brummel NE, Girard TD, Ely EW, Pandharipande PP; COVID-19 Intensive Care International Study Group. Prevalence and risk factors for delirium in critically ill patients with COVID-19 (COVID-D): a multicentre cohort study. Lancet Respir Med. 2021 Mar;9(3):239-250. doi: 10.1016/S2213-2600(20)30552-X. Epub 2021 Jan 8. Erratum In: Lancet Respir Med. 2021 Jan 27;: — View Citation

Smith CD, Grami P. Feasibility and Effectiveness of a Delirium Prevention Bundle in Critically Ill Patients. Am J Crit Care. 2016 Dec;26(1):19-27. doi: 10.4037/ajcc2017374. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive scores	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.	30 days post-randomization.
Other	Depression anxiety scores	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	30 days post-randomization.
Other	CAM ICU concordance	Agreement between CAM ICU assessment between Eyecontrol and investigator administered CAM-ICU in active intervention arm	During device usage upto 7 days
Other	Cumulative dose of sedatives	Dose of intravenous sedatives between 2 groups (in mgs/mcgs)	During device usage or upto 7 days whichever is sooner
Other	Days free of restraints	Comparison of days free of restraints between 2 groups	Upto 7 days or discharge from intensive care unit
Other	Use of rescue medications for delirium and agitation	Use of medications for agitated delirium	Upto 7 days or discharge from intensive care unit
Other	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
Primary	Prevalence of CAM ICU+ assessments during the first 7 days in ICU post-randomization or ICU discharge/death (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 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.	Upto 7 days or liberation from ventilator whichever is sooner.
Secondary	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)	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.	Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner
Secondary	Mean number of days with delirium (defined as the total number of days with at least one CAM ICU positive delirium assessment) within 7 days post-randomization or up to discharge from the ICU/death, whatever occurs earlier.	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.	Upto 7 days or discharge from intensive care unit (ICU) whichever is sooner