Improving comfort measures for patients withdrawing from mechanical ventilation
Feasibility of the Comfort Measures Only Time Out (CMOT) to Reduce Distress During Palliative Withdrawal of Mechanical Ventilation
This study is testing a new way to help patients who are being taken off mechanical ventilation in ICUs feel more comfortable and cared for during this difficult time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05861323 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a structured intervention called the Comfort Measures Only Time Out (CMOT) to enhance the process of withdrawing mechanical ventilation in intensive care units (ICUs). The intervention involves a checklist protocol for ICU teams, including nurses, physicians, and respiratory therapists, to ensure a compassionate and organized approach during this critical time. The study will pilot test the CMOT in four ICUs, focusing on 40 patients who are undergoing withdrawal of mechanical ventilation. Feedback from ICU teams will be used to refine the intervention for better implementation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a decision made for withdrawal of mechanical ventilation but have not yet undergone the procedure.
Not a fit: Patients who are not undergoing withdrawal of mechanical ventilation or are unable to communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce patient distress during the withdrawal of mechanical ventilation, leading to a more humane end-of-life experience.
How similar studies have performed: While this approach is novel in its structured intervention for comfort measures during mechanical ventilation withdrawal, similar studies have highlighted the importance of reducing patient distress in end-of-life care.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Corey R Fehnel, MD, MPH — Co-Director, Neuroscience Intensive Care Unit
- Study coordinator: Corey R Fehnel, MD, MPH
- Email: cfehnel@bidmc.harvard.edu
- Phone: 617-667-5345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.