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CMOT Protocol for End of Life Care

N/A

Recruiting

Led By Corey R Fehnel, MD, MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Decision made for withdrawal of mechanical ventilation (WMV) by patient/surrogate and ICU team

Age ≥ 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surveys will be completed at three hours of withdrawal of mechanical ventilation, or within 72-hours. the measure will be reported at time of study completion (approximately 1-year)

Awards & highlights

Study Summary

This trial will investigate ways to reduce distress for almost 1 in 4 Americans who die in the ICU due to withdrawal of mechanical ventilation.

Who is the study for?

This trial is for adults over 18 involved in ICU care, including nurses, physicians, and respiratory therapists who will be providing at least one hour of pre-extubation care to patients facing the end of life due to conditions like respiratory failure. Participants must speak English and be part of a team where the decision for withdrawal of mechanical ventilation has been made.Check my eligibility

What is being tested?

The study is testing a new protocol called Comfort Measures Only Time Out (CMOT), which involves a structured time out with a checklist for ICU teams. This aims to improve patient comfort during the process of withdrawing from ventilator support at the end-of-life stage in ICUs.See study design

What are the potential side effects?

Since this intervention focuses on non-medical procedures aimed at improving comfort during ventilator withdrawal, there are no direct medical side effects associated with CMOT itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I or my surrogate and the ICU team have decided to stop using the breathing machine.

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I am 18 years old or older.

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I have cared for a ventilated patient for at least 1 hour before they were taken off the ventilator.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surveys will be completed at three hours of withdrawal of mechanical ventilation, or within 72-hours. the measure will be reported at time of study completion (approximately 1-year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surveys will be completed at three hours of withdrawal of mechanical ventilation, or within 72-hours. the measure will be reported at time of study completion (approximately 1-year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and surveys will be completed at three hours of withdrawal of mechanical ventilation, or within 72-hours. the measure will be reported at time of study completion (approximately 1-year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Protocol adherence

Study recruitment rate

Secondary outcome measures

Recommendation for future use

Other outcome measures

Distressful episodes

Trial Design

1Treatment groups

Experimental Treatment

Group I: Check-list ArmExperimental Treatment1 Intervention

This feasibility study will test an ICU team-based time and and check-list intervention, the Comfort Measures Only Time Out (CMOT). The CMOT is designed to improve ICU team communication and better address patient comfort at the end of life. Participants in the CMOT are intensive care unit clinicians who are caring for a patient who is about to undergo palliative withdrawal of mechanical ventilation at the end of life. Feasibility will be assessed by: recruitment rates, protocol adherence, and acceptability to clinicians. Patient level outcomes such as distressful episodes/person-time alive will also be collected as a component of routine care in this exploratory analysis. The maximum time any participant (ICU clinician or patient) will be participating in the study is about four hours.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,088 Total Patients Enrolled

8 Trials studying Respiratory Failure

11,239 Patients Enrolled for Respiratory Failure

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,701 Total Patients Enrolled

Hebrew SeniorLifeOTHER

45 Previous Clinical Trials

270,365 Total Patients Enrolled

Media Library

Check-list Arm Clinical Trial Eligibility Overview. Trial Name: NCT05861323 — N/A

Respiratory Failure Research Study Groups: Check-list Arm

Respiratory Failure Clinical Trial 2023: Check-list Arm Highlights & Side Effects. Trial Name: NCT05861323 — N/A

Check-list Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05861323 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if this clinical trial is currently enrolling participants?

"It appears that the clinical trial is no longer recruiting participants. Data hosted on clinicaltrials.gov indicates its initial posting was July 1st 2023 and it last edited May 12th, 2023. At present time there are 530 other trials in search of patients though this one has ended recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of the Comfort Measures Only Time Out (CMOT)

Corey R. Fehnel 2023. "Feasibility of the Comfort Measures Only Time Out (CMOT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05861323.