What side effects are associated with this type of intervention?

Common treatments for respiratory failure, such as mechanical ventilation, oxygen therapy, bronchodilators, and steroids, have various side effects. Mechanical ventilation can cause ventilator-associated pneumonia, lung injury, and discomfort. Oxygen therapy may lead to oxygen toxicity if used excessively. Bronchodilators can result in tremors, palpitations, and headaches, while steroids may cause immunosuppression, hyperglycemia, and muscle weakness. The withdrawal of mechanical ventilation (WMV) can cause patient distress, anxiety, and discomfort, which interventions like the Comfort Measures Only Time out (CMOT) aim to alleviate.

What prior FDA approvals exist?

FDA approvals for the treatment of respiratory failure primarily include mechanical ventilation devices and supportive care measures. Mechanical ventilators are critical for patients with severe respiratory failure, providing necessary respiratory support. Additionally, various medications such as sedatives, analgesics, and neuromuscular blocking agents are approved to facilitate mechanical ventilation and ensure patient comfort. While the Comfort Measures Only Time Out (CMOT) trial focuses on a procedural intervention to improve the WMV process, it complements these FDA-approved treatments by aiming to enhance the quality of palliative care during the withdrawal of mechanical ventilation.

What other types of research exist?

Promising alternatives to CMOT for respiratory failure patients include the implementation of a tracheostomy rounding team (TRT) to improve provider comfort and patient care, and the use of noninvasive ventilation devices to facilitate ICU discharge for patients with prolonged weaning following tracheotomy. Additionally, cognitive distraction and relaxation procedures have shown effectiveness in reducing anxiety behaviors in ventilator-dependent patients, which could improve the overall WMV process.

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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

Must not have

Unable to communicate in English

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

No Placebo-Only Group

Summary

This trial tests a new method called Comfort Measures Only Time Out (CMOT) for ICU teams. It involves a structured pause and checklist to ensure patients are comfortable when their ventilator is removed. The goal is to reduce distress in patients during this process.

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.

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.

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.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot communicate in English.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Protocol adherence

Study recruitment rate

Secondary study objectives

Recommendation for future use

Other study objectives

Distressful episodes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Comfort Measures Only Time Out (CMOT) trial focuses on improving the process of withdrawing mechanical ventilation (WMV) through a structured time out with a checklist protocol. This approach involves the careful titration of sedatives and analgesics to manage patient distress and discomfort, the gradual reduction of ventilatory support to allow natural breathing to resume, and the involvement of a multidisciplinary team to address all aspects of patient care. These measures are essential for respiratory failure patients as they help minimize suffering, ensure a humane approach to end-of-life care, and provide a structured, compassionate framework for healthcare providers.

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