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Search / Trial NCT05861323

Feasibility of the Comfort Measures Only Time Out (CMOT)

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · May 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called the Comfort Measures Only Time Out (CMOT) to help improve the experience for patients who are about to have their breathing support (ventilator) removed in intensive care units (ICUs). Unfortunately, many patients in these situations can feel distress or suffering. The goal of this study is to create and test a step-by-step process that healthcare teams (like nurses and doctors) can use to make this transition as comfortable as possible for patients and their families.

To participate, patients must be at least 18 years old and have made the decision, along with their healthcare team, to withdraw ventilation support, but this process has not yet started. The study will involve about 40 patients across four different ICUs. Families can expect that the healthcare team will follow a structured protocol to ensure the best possible care during this difficult time. There are no specific exclusion criteria for patients, but for ICU staff, they must be able to communicate in English and have been caring for the patient for at least one hour before the ventilation is withdrawn. Overall, this trial aims to provide better support and comfort to patients and their loved ones during the end-of-life process.

Gender

ALL

Eligibility criteria

  • Patient Inclusion Criteria
  • Age ≥ 18
  • Decision made for withdrawal of mechanical ventilation (WMV) by patient/surrogate and ICU team
  • WMV has not yet occurred
  • Patient Exclusion Criteria
  • • None
  • ICU Clinician Inclusion Criteria:
  • ICU nurse, Physician/Advance Practice Provider, or respiratory therapist
  • Age ≥ 18
  • Providing direct care to WMV patient for at least 1-hour pre-extubation
  • ICU Clinician Exclusion criteria:
  • • Unable to communicate in English

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

Patients applied

0 patients applied

Trial Officials

Corey R Fehnel, MD, MPH

Principal Investigator

Co-Director, Neuroscience Intensive Care Unit

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported