Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 17
- 主要终点
- Endotracheal intubation
研究概览
简要总结
The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.
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
- •Adults ≥ 18 years of age.
- •Suspected or confirmed COVID-
- •Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-
- •Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
- •Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
- •Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.
排除标准
- •Immediate need for intubation as determined by the treating team.
- •Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
- •Contraindication to proning including, but not limited to any of the following:
- •Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, Unstable spine, facial, cervical, femur, or pelvic fractures. Limited neck mobility or inability to lie prone comfortably Skeletal deformities that interfere with proning. Complete bowel obstruction. Active upper gastrointestinal bleeding. Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.
- •Body mass index > 40 kg/m2
- •Pregnancy - third trimester.
- •Patient/substitute decision maker or caring physician's refusal to enroll in the study.
- •Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)
- •Intubation is not within patient's goals of care
- •Patient received awake proning session for > 1 day prior to randomization
- •Previous intubation within the same hospital admission
研究组 & 干预措施
Intervention - Awake Proning
The oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment.
Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning.
干预措施: Awake Proning (Procedure)
Control - Standard of Care
The patient will receive usual care without proning at the discretion of the treating team.
The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment.
结局指标
主要结局
Endotracheal intubation
时间窗: within 30 days of randomization
Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
次要结局
- Mortality(60 days)
- Days alive and outside of hospital(60 days)
- Complications from proning,(30 days)
- Invasive mechanical ventilation free days(censored at 30 Days)
- Days alive and outside ICU(60 Days)
- Non-invasive ventilation free days(censored 30 days)
研究者
Waleed Al-Hazzani
Principal Investigator
St. Joseph's Healthcare Hamilton