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Active Not Recruiting NCT05861323

Feasibility of the Comfort Measures Only Time Out (CMOT)

Conditions: End of Life, Respiratory Failure, Ventilatory Failure, Coma, Aging

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 184
Sponsor: Beth Israel Deaconess Medical Center

Location: Beth Israel Deaconess Medical center Boston Massachusetts

Summary

Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are expected and involve the removal of ventilator support, or palliative withdrawal of mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that patient suffering can be common; with 30-59% of patients going through this process experiencing distress. Thus, experts and national organizations have called for evidence to inform guidelines for WMV. This research study will 1) develop and refine a Comfort Measures Only Time out (CMOT) intervention consisting of a structured time out with check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2 surgical) among 40 WMV patients.

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05861323). StuddyBuddy aggregates publicly available trial information.