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Search / Trial NCT06029244

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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Sep 1, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

The EMERGE trial is studying a new tool called the EyeControl-Pro platform to see if it can help reduce the occurrence and severity of delirium in critically ill patients who are on mechanical ventilation in the Intensive Care Unit (ICU). Delirium is a serious condition that causes confusion and changes in mental state, which can be particularly common in older patients. The researchers want to find out if using this platform alongside standard care can make a positive difference for patients during their treatment.

To be eligible for this trial, patients need to be at least 50 years old and on mechanical ventilation for at least 24 hours, with a certain level of alertness. However, patients who are not expected to survive for more than 24 hours, have advanced dementia, or have other significant health issues may not qualify. If a patient joins the study, they can expect to use the EyeControl-Pro platform while receiving their usual ICU care. It's important to note that participants will need to be able to communicate in the local language and have a legally appointed representative if needed. This research aims to improve the way we manage delirium in critically ill patients, which could lead to better health outcomes.

Gender

ALL

Eligibility 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.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.

Locations

Boston, Massachusetts, United States

Petah Tikva, , Israel

Ashdod, , Israel

Patients applied

0 patients applied

Trial Officials

Somnath Bose, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported