Protocolized Post-Extubation Respiratory Support (PROPER) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- Reintubation
研究概览
简要总结
Invasive mechanical ventilation is common in the medical intensive care unit, and the period of time following extubation remains high risk as 11 to 15% of patients require reintubation after their first extubation. Reintubation is associated with increased rates of nosocomial infection and is an independent predictor of mortality. Non-invasive ventilation and high flow nasal cannula are the only therapies that have been shown to reduce the rate of reintubation. Recent clinical trials suggest that all patients might benefit from some form of post-extubation respiratory support, but use of these therapies in usual care remains low. PROPER is a cluster-randomized, multiple-crossover trial comparing a respiratory therapist driven protocol to provide post-extubation respiratory support to all patients, compared to usual care. The trial will enroll patients undergoing extubation in the Medical ICU at Vanderbilt from October 2017 until March 2019. The primary outcome will be reintubation within 96 hours.
详细描述
PROPER is a prospective, pragmatic, cluster-randomized, multiple-crossover trial comparing a respiratory therapist driven protocol for post-extubation respiratory support to usual care. The primary outcome will be reintubation by 96 hours. All adults (age 18 or older) who receive at least 12 hours of mechanical ventilation and are extubated in the Vanderbilt Medical ICU will be enrolled in the trial. The ICU will be divided into 2 clusters, based on the geographic areas covered by the two respiratory therapist dedicated to that ICU. The study will occur in three month blocks. One cluster will be randomized to receive protocolized post-extubation respiratory support (as prescribed by a protocol and delivered by a respiratory therapist), while the other cluster receives usual care, which can include post-extubation respiratory support when requested by the clinical team. At the end of three months, the clusters will cross-over, such that each cluster will spend half of the study receiving protocolized post-extubation respiratory and half of the study receiving usual care. It is anticipated that approximately 630 patients will be enrolled from the medical ICU during the 18 month study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is located in a participating unit
- •Patient undergoing extubation from mechanical ventilation
- •Patient has been receiving mechanical ventilation for at least 12 hours
- •Age ≥ 18 years old
排除标准
- •Patient is receiving ventilation via a tracheostomy
- •Patient is being extubated to comfort measures or has "Do Not Reintubate" order in place at the time of extubation
- •Patient has required reintubation after a prior attempt at extubation during this hospitalization
- •Unplanned or self-extubation, where immediate reintubation is deemed necessary by the clinical team
研究组 & 干预措施
Protocolized Post-extubation Respiratory Support
Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning
干预措施: Protocolized post-extubation respiratory support (Other)
Usual Care
Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
干预措施: Usual Care (Other)
结局指标
主要结局
Reintubation
时间窗: within 96 hours of extubation
Any placement of an endotracheal tube for any indication within 96 hours of extubation, censored at the first of hospital discharge or 96 hours after extubation
次要结局
- All-cause In-hospital Death(from extubation to discharge or 28 days post-extubation)
- Time to Reintubation(from extubation to discharge or 28 days post-extubation)
- Number of Patients Requiring Re-intubation for Respiratory Indication(within 96 hours of extubation)
- Use of High Flow Nasal Cannula (HFNC) or Non-invasive Ventilation (NIV) Beyond 24 Hours Post-extubation(from 24 hours post extubation to 96 hours post-extubation)
- ICU-free Days(from extubation to discharge or 28 days post-extubation)
- Number of Patients Requiring Reintubation for Laryngeal Edema(within 96 hours of extubation)
- Lowest S/F Ratio(between 0-6 hours, 6-12 hours, and 12-24 hours after extubation)
- Ventilator-free Days(from extubation to discharge or 28 days post-extubation)
- Number of Patients With Delirium(within 96 hours of extubation)
- Number of Patients With Agitation(within 96 hours of extubation)
- Highest Respiratory Rate(between 0-6 hours, 6-12 hours, and 12-24 hours after extubation)
研究者
Jonathan Casey
Pulmonary and Critical Care Medicine Research Fellow
Vanderbilt University Medical Center