Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.
研究概览
简要总结
Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.
详细描述
Prone positioning (PP) is an adjunctive therapy used that has been proven to save lives in sedated patients with confirmed moderate-severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (MV). PP involves placing patients in the prone, i.e. face down position for time periods of up to 16 hours per day. PP promotes lung homogeneity, improves gas exchange and respiratory mechanics permitting reduction of ventilation intensity, and reducing ventilator-induced lung injury (VILI).
Maintaining self-ventilation is associated with increased aeration of dependent lung regions, less need for sedation, improved cardiac filling and removes the risk of VILI, and so is an important therapeutic goal in hypoxic patients. The use of PP in awake self-ventilating patients with COVID-19 induced acute hypoxic respiratory failure (AHRF) and/or ARDS could improve gas exchange and reduce the need for invasive MV, but has not been studied outside of case series.
However, an increase in oxygenation does not necessarily reduce the risk of invasive MV. PP has significant attached risks such as causing pressure sores in patients, PP is uncomfortable for some patients, it increases nursing workload, and if ineffective could hinder the delivery of other (effective) medical care. Hence there is a need to determine if PP of awake patients is effective in reducing the need for invasive MV. This multi-centre, open label, randomized controlled study of COVID-19 induced AHRF/ARDS will determine if PP reduces the need for 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
- Double (Investigator, 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
- •Suspected or confirmed COVID19 infection
- •Bilateral Infiltrates on CXR
- •SpO2 <94% on FiO2 40% by either venturi facemask or high flow nasal cannula
- •Written informed consent
排除标准
- •Uncooperative or likely to be unable to lie on abdomen for 16 hours
- •Receiving comfort care only
- •Multi-organ failure
- •Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury).
结局指标
主要结局
The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.
时间窗: Up to 28 days post randomisation
A measure of effect of awake prone positioning in patients with confirmed or suspected COVID-19 acute hypoxemic respiratory failure undergoing supplemental oxygen via high flow nasal cannular oxygen on reducing requirement for invasive mechanical ventilation or death. Outcome measure is calculated as a count of the number of patients who went onto require invasive mechanical ventilation or died up to 28 days post randomization.
次要结局
- PaO2/FiO2 Ratio After 1 Hours of Prone Positioning(During intervention)
- SpO2/FiO2 Ratio After 1 Hour in Prone Positioning(During Intervention)
- Length of Time Tolerating Prone Positioning(Daily during intervention up to 14 days post randomisation)
- PaO2/FiO2 Ratio Measured Before Prone Positioning(Immediately before intervention)
- Number Requiring Increase in Ventilatory Assistance(Up to 28 days post randomisation)
- Work of Breathing Assessment (Respiratory Distress Scale)(Immediately before and during intervention)
- Changes in Bioimpedance Measures of Lung Edema in Patients in PP(During intervention)
- SpO2/FiO2 Ratio Measured Before Prone Positioning(Immediately before intervention)
- Use of Awake Prone Positioning as a Rescue Intervention in Control Patients(Up to 28 days post randomisation)
研究者
John Laffey
Professor, Anaesthesia and Intensive Care Medicine, School of Medicine, NUI Galway
University College Hospital Galway