Efficacy of Timed Awake Prone and Repositioning in Patients With Covid-19-induced Hypoxic Respiratory Failure: a Multi-center, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 286
- 试验地点
- 3
- 主要终点
- Endotracheal Intubation rate
研究概览
简要总结
Awake prone positioning has been reported to improve oxygenation for patients with COVID-19. Awake timed and repositioning is a novel method to improve patients' compliance and prolong the prone time. This study aims to explore the impact of timed prone and repositioning on the intubation rate and prognosis of COVID-19 patients with hypoxic respiratory failure.
详细描述
Patients with COVID-19 may develop severe illness characterized by progressive hypoxic respiratory failure, resulting in the need for invasive mechanical ventilation. Reducing the rate of endotracheal intubation in patients with hypoxic respiratory failure can be beneficial to the prognosis, economize iatrical resources and reduce sanitary investment. Some studies have shown that prone positioning can improve oxygenation to some extent in patients receiving invasive mechanical ventilation due to severe ARDS.
Whether awake prone positioning can reduce endotracheal intubation and mortality in COVID-19 patients with hypoxic respiratory failure is still controversial. A meta-analysis found that the awake prone positioning was safe and feasible to reduce the risk of intubation or death. However, the multicenter randomized controlled trial (RCT) conducted by Alhazzani et al pointed out that the awake prone positioning group did not significantly reduce the rate of endotracheal intubation when compared with the standard of care.
Some researchers thought the time of prone positioning is an important factor for the different results. In previous studies, the median duration of prone positioning was only 4.8-5 hours per day but some guidelines recommend the duration should be more than 8 hours. Therefore, increasing patient adherence in the awake prone positioning and extending prone positioning time are of great importance.
Awake timed prone and repositioning is a novel method proposed in recent years, which can improve patients' compliance and prolong the time of treatment. This study intends to ask whether awake timed prone and repositioning could impact the intubation rate and prognosis of unincubated patients with hypoxic respiratory failure induced by COVID-19.
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
- •Awake patients without endotracheal intubation
- •Suspected or confirmed infection of COVID-19
- •Hypoxemia requiring oxygen supplementation ≥ 0.4 FiO2 or ≥ 5L/min via nasal cannula
- •Bilateral or unilateral chest infiltrates on x-ray or HRCT
- •Admitted to the ICU or an acute care unit where hemodynamic and respiratory
- •Willingness to comply with the protocol and provide written informed consent
排除标准
- •Risk of airway obstruction or even asphyxia
- •Need for emergent intubation after admission
- •Respiratory failure caused by cardiogenic pulmonary edema
- •Unable to implement timed prone and repositioning due to any cause
- •Injury or wound on the ventral body surface affecting the prone position
- •Unstable fracture of cervical vertebra and spine
- •Glaucoma or other sharp increases in intraocular pressure
- •Intracranial hypertension caused by traumatic brain injury etc.
- •Significantly high risk of pulmonary embolism
- •Acute hemorrhagic disease
- •Respiratory rate >40 breaths/min, with significant dyspnea
- •Transcutaneous oxygen saturation can not be continuously monitored
- •Hemodynamic instability requiring vasoactive drugs (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg despite adequate volume resuscitation)
- •Awareness disorder or inability to accept instructions, communication barrier with the nursing team, inability to use language or pager to call for help
- •Difficulty or limitation in autonomous movement, inability to adjust the position without assistance from others
- •Body mass index > 37 kg/m2
结局指标
主要结局
Endotracheal Intubation rate
时间窗: Day 30
The incidence of endotracheal Intubation within 30 days of study enrollment
次要结局
- Days of non-invasive ventilation(Day 30)
- Days alive and outside the ICU(Day 30)
- Clinical events(Day 30)
- Mortality(Day 30)
研究者
Min Yan
Chief of Department of Anesthesia and Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University