COMPLETED

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

Conditions

Delirium Delirium in Old Age Critical Illness Intensive Care Unit Delirium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-25

Study Completion:2025-11-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06029244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Mechanically ventilated patients aged \>=50 years * RASS score of -3 to +1 and * Anticipated to require \>=24 hours of mechanical ventilation	* 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.

Inclusion Criteria

Exclusion Criteria

* Mechanically ventilated patients aged \>=50 years
* RASS score of -3 to +1 and
* Anticipated to require \>=24 hours of mechanical ventilation

* 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.

Contacts and Locations

Principal Investigator

Somnath Bose, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Somnath Bose, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-25

Study Completion Date2025-11-18

Study Record Updates

Study Start Date2024-02-25

Study Completion Date2025-11-18

Terms related to this study

Additional Relevant MeSH Terms

Delirium
Delirium in Old Age
Critical Illness
Intensive Care Unit Delirium