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

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Abigail G Fischer, Margaret L Campbell, Margaret M Hayes, Richard M Schwartzstein, Douglas B White, Susan L Mitchell, Corey R Fehnel
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引用次数: 0

Abstract

Introduction: 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.

Methods: 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.

Discussion: 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.

Trial registration: Clinical trials.gov ( NCT05861323 ); 16 May 2023.

研究方案测试仅舒适措施暂停(CMOT)在缓解性机械通气停药期间减少窘迫的可行性。
简介:超过30%的患者在重症监护病房临终时停止机械通气时经历过痛苦。在这一过程中,风险因素识别和痛苦管理的具体方法缺乏高质量的证据。结构化的“暂停”和检查表干预改善了手术结果,并已广泛应用于程序性护理,但尚未在重症监护病房的临终治疗中进行测试。方法:我们在一项非随机的单臂先导研究中描述了一种新的暂停检查表干预的开发和计划测试,即舒适措施暂停(CMOT)。干预措施的制定以已发表的文献和一个结构化的跨专业咨询小组为指导。该干预措施将由临床团队进行测试,他们将照顾46名接受姑息性机械通气停药的患者。护士、医生、高级实践提供者和呼吸治疗师将在取下机械通气前一小时内集合完成清单。实施结果,包括可行性,将通过12个问题的调查和临床医生协议的依从性来衡量。效应量计算将决定未来随机对照试验检验CMOT在减轻患者痛苦方面的有效性。讨论:本方案将试点测试CMOT的可行性,CMOT是一种结构化的暂停和检查表干预,用于ICU的WMV。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以程序和重症监护环境中已经采用的质量和安全框架为基础。鉴于高痛苦率,CMOT将填补围绕WMV过程的证据中已确定的空白。试验注册:Clinical trials.gov (NCT05861323);2023年5月16日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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