A Physiological Study to Assess the Effects of Awake Prone Positioning in Healthy Volunteers Under Different Respiratory Support: A Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ventilation distribution assessed by EIT
研究概览
简要总结
Awake prone positioning (APP) has been proven to reduce the intubation rate for patients with COVID-19-induced hypoxemic respiratory failure. Our recent meta-analysis found APP was only effective for patients who were treated by high-flow nasal cannula (HFNC), not for patients using conventional oxygen therapy (COT).In a recent multicenter RCT, Perkins and colleagues reported that continuous positive airway pressure (CPAP) was superior to HFNC and conventional oxygen therapy in reducing intubation rate. Thus, it is essential to evaluate the physiological mechanism of APP under different respiratory supports, such as COT, HFNC, or CPAP.
We hypothesize that HFNC or CPAP is more effective when combined with APP than COT combined with APP. Electrical impedance tomography (EIT imaging) has been broadly utilized to assess patient ventilation homogeneity and respiratory volume monitor (RVM) has been used to evaluate patient's tidal volumes breath-by-breath. In this study, 20 healthy volunteers will use different respiratory support devices (HFNC, CPAP, and COT) in different settings and their combinations withAPP in a random sequence, assessed by EIT and RVM.
详细描述
Awake prone positioning (APP) has been proven to reduce the intubation rate for patients with COVID-19-induced hypoxemic respiratory failure. Our recent meta-analysis found APP was only effective for patients who were treated by high-flow nasal cannula (HFNC), not for patients using conventional oxygen therapy (COT).In a recent multicenter RCT, Perkins and colleagues reported that continuous positive airway pressure (CPAP) was superior to HFNC and conventional oxygen therapy in reducing intubation rate. Thus, it is essential to evaluate the physiological mechanism of APP under different respiratory supports, such as COT, HFNC, or CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults aged between 21 to 65 years
排除标准
- •Tested COVID positive within 21 days, or has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit.
- •Currently have the following symptoms: sore throat, fever, coughing, shortness of breath, loss of smell or taste
- •Non-English speaking
- •Has any of the following diseases: asthma, chronic obstructive pulmonary disease, Uncontrolled Diabetes, hypertension, or untreated thyroid disease
- •and spinal cord injury.
- •Claustrophobia
- •Pregnancy
- •Pacemaker (EIT contraindication)
- •face or chest skin injury that could not use a facemask or the electrode belt
- •could not tolerate prone positioning for one hour
研究组 & 干预措施
awake prone positioning with room air
Participants will stay in the prone position
干预措施: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) (Other)
awake prone positioning with high-flow nasal cannula
Participants will stay in the prone position and breathe with high-flow nasal cannula
干预措施: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) (Other)
awake prone positioning with continuous positive airway pressure
Participants will stay in the prone position and breathe with continuous positive airway pressure via face mask
干预措施: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) (Other)
supine position with room air
Participants will stay in the supine position
supine position with high-flow nasal cannula
Participants will stay in the supine position and breathe with high-flow nasal cannula
干预措施: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) (Other)
supine position with continuous positive airway pressure
Participants will stay in the supine position and breathe with continuous positive airway pressure via face mask
干预措施: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) (Other)
结局指标
主要结局
ventilation distribution assessed by EIT
时间窗: 20 minutes
Regional ventilation assessed by regional tidal impedance variations relative to global tidal impedance variation (ΔzROI/Δzglobal) obtained by electrical impedance tomography (EIT)
次要结局
- tidal volume(20 minutes)
- respiratory rates(20 minutes)
- comfort(20 minutes)
研究者
Jie Li
Associate Professor
Rush University Medical Center