Fischer Abigail G, Campbell Margaret L, Hayes Margaret M, Schwartzstein Richard M, White Douglas B, Mitchell Susan L, Fehnel Corey R
Beth Israel Deaconess Medical Center, 110 Francis St, Lowry 9A, Boston, 02215, MA , USA.
Wayne State University, College of Nursing, Detroit, USA.
Pilot Feasibility Stud. 2025 Aug 13;11(1):109. doi: 10.1186/s40814-025-01688-4.
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.
在重症监护病房临终时进行姑息性撤机的过程中，超过30%的患者会出现痛苦情绪。目前缺乏关于在此过程中识别痛苦情绪风险因素及管理的具体方法的高质量证据。结构化的“暂停”和清单干预可改善手术结果，并已在程序护理中广泛采用，但尚未在重症监护病房临终环境中进行测试。
我们在一项非随机单臂试点研究中描述了一种新型暂停清单干预措施——仅采取舒适措施暂停（CMOT）的开发和计划测试。干预措施的开发以已发表的文献和结构化的跨专业咨询小组为指导。该干预措施将由负责照顾46名接受姑息性撤机的患者的临床团队进行测试。护士、医生、高级执业提供者和呼吸治疗师将在撤机前一小时内集合完成清单。实施结果，包括可行性，将通过一项12个问题的调查和临床医生对方案的依从性来衡量。效应量计算将确定未来测试CMOT减少患者痛苦效果的随机对照试验的效能。
本方案将对CMOT（一种结构化的暂停和清单干预措施）在重症监护病房进行撤机时的可行性进行试点测试。该研究将为未来随机对照试验的方案和干预措施的潜在变化提供信息。CMOT基于程序护理和重症护理环境中已采用的质量和安全框架。鉴于痛苦情绪的高发生率，CMOT将填补围绕撤机过程的现有证据空白。
ClinicalTrials.gov（NCT05861323）；2023年5月16日。
