A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 8
- 主要终点
- Hospital mortality or discharge to hospice
研究概览
简要总结
The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
详细描述
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients.
The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Hospitalized patients with probable COVID-
- •Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
- •Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
- •Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
- •Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).
排除标准
- •Decreased level of consciousness (Glasgow Coma Scale < 10) or precluding ability to self-reposition.
- •Hemodynamic instability (Systolic Blood Pressure < 90 mmHg and or Lactate >5 mmol/L or HR >120, not responsive to fluid resuscitation).
- •Complete bowel obstruction.
- •Active upper gastrointestinal bleeding.
- •Poor neck mobility or patient inability to lie prone comfortably.
- •Unstable spine, femur, or pelvic fractures.
- •Pregnancy - third trimester.
- •Full resuscitation status including ICU and willingness to accept invasive mechanical ventilation (i.e. R1/R2 goals of care).
- •Imminent palliation or end of life expected on admission (i.e. C1/C2 goals of care).
研究组 & 干预措施
Prone Positioning (PP)
The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day.
干预措施: Prone Positioning (PP) (Procedure)
Control - usual management
The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.
结局指标
主要结局
Hospital mortality or discharge to hospice
时间窗: 60 days
In-hospital mortality or discharge to hospice at Day 60.
次要结局
- Change in SpO2(60 days)
- Hospital free days(60 days)
- Adverse Events and Serious Adverse Events(60 days)
- Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).(60 days)
- In-hospital death (time)(60 days)
- Death at 90 days(90 days)
- Oxygen-free days(60 days)
- Admission to ICU(60 days)
- Intubation and mechanical ventilation(60 days)
研究者
Ken Kuljit Parhar, MD
Consultant Intensivist & Clinical Assistant Professor
University of Calgary