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临床试验/NCT03121391
NCT03121391已完成不适用

An Algorithmic Approach to Ventilator Withdrawal at the End of Life

Wayne State University10 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2017年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
10
主要终点
Patient respiratory comfort

研究概览

简要总结

The proposed study is an important, under-investigated area of ICU care for terminally ill patients undergoing terminal ventilator withdrawal. The proposed research has relevance to public health because an algorithmic approach to the ventilator withdrawal process will enhance clinicians' ability to conduct the process while assuring patient comfort, using opioids and/or benzodiazepines effectively.

详细描述

Terminal ventilator withdrawal is a process that entails the cessation of mechanical ventilatory support with patients who are unable to sustain spontaneous breathing and is commonly performed in the ICU. Ventilator withdrawal is undertaken to allow a natural death. Opioids and/or benzodiazepines are administered before, during, and after as an integral component of the ventilator withdrawal process to prevent or relieve respiratory distress, but there are few guidelines to determine how much to administer or when. Insufficient opioid and/or benzodiazepine administration places the patient at risk for unrelieved respiratory distress and preventable suffering. Conversely, excessive medication administration may hasten death, an unintended consequence, and one that concerns clinicians. The effective doses of medications given during ventilator withdrawal are unknown. The investigators hypothesize that an algorithmic approach to ventilator withdrawal, relying on a biobehavioral instrument to measure and trend distress, will ensure patient comfort, and guide effective opioid and/or benzodiazepine administration. The investigators plan to use a stepped wedge cluster randomized controlled trial with all clusters providing unstructured usual care until each cluster is randomized to implement the algorithmic approach (intervention). The proposed study is innovative because there is no standardized, evidence-based approach guided by an objective measure of respiratory distress to this common ICU procedure. The study has broad clinical significance to provide knowledge that can potentially reduce patient suffering.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

盲法说明

All study sites begin in usual care and each site is randomly assigned to crossover to the intervention arm until all sites conclude in the intervention arm.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing ventilator withdrawal

排除标准

  • Patients who are conscious and cognitively intact
  • Patients who will undergo organ donation after ventilator withdrawal
  • Patients who are brain dead
  • Patients with bulbar amyotrophic lateral sclerosis
  • Patients with C-1 to C-4 quadriplegia
  • Patients with locked-in syndrome

结局指标

主要结局

Patient respiratory comfort

时间窗: Change from baseline through repeated measures up to 8 hours

Respiratory comfort will be measured with the Respiratory Distress Observation Scale at baseline, at every ventilator change, after the ventilator is turned off, every 15-minutes for 2 hours after the ventilator is turned off.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Campbell

Professor

Wayne State University

研究点 (10)

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