Study protocol testing feasibility of the Comfort Measures Only Time out (CMOT) to reduce distress during palliative...

Distress is experienced by more than 30% of patients during palliative withdrawal of mechanical ventilation at the end of life in the intensive care unit. There is a lack of high-quality evidence for specific approaches to risk factor identification and management of distress during this process. Structured "time-outs" and checklist interventions improve surgical outcomes and have been widely adopted in procedural care, but they have not been tested for use at end-of-life in intensive care unit settings.

We describe the development and planned testing of a novel time-out checklist intervention, the Comfort Measures Only Time Out (CMOT) in a non-randomized single arm pilot study. Intervention development was guided by published literature and a structured inter-professional advisory panel. The intervention will be tested by clinical teams caring for 46 patients undergoing palliative withdrawal of mechanical ventilation. Nurses, physicians, advanced practice providers, and respiratory therapists will convene within an hour before withdrawal of mechanical ventilation to complete the checklist. Implementation outcomes, including feasibility, will be measured by a 12-question survey and by clinician protocol adherence. Effect size calculations will determine power for future randomized controlled trials testing efficacy of the CMOT in reducing patient distress.

This protocol will pilot test the feasibility of the CMOT, a structured time-out and checklist intervention, for WMV in the ICU. The study will inform potential changes to the protocol and intervention for a future randomized control trial. The CMOT is grounded in a quality and safety framework already adopted in procedural and critical care settings. Given high rates of distress, the CMOT will fill an identified gap in evidence surrounding the process of WMV.

Clinical trials.gov ( NCT05861323 ); 16 May 2023.