A Physiological Study to Assess Awake Prone Positioning and Respiratory Support in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- Other: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure)
- Registration Number
- NCT05512585
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
healthy adults aged between 21 to 65 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description awake prone positioning with room air awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) Participants will stay in the prone position supine position with high-flow nasal cannula awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) Participants will stay in the supine position and breathe with high-flow nasal cannula supine position with continuous positive airway pressure awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) Participants will stay in the supine position and breathe with continuous positive airway pressure via face mask awake prone positioning with continuous positive airway pressure awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) Participants will stay in the prone position and breathe with continuous positive airway pressure via face mask awake prone positioning with high-flow nasal cannula awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) Participants will stay in the prone position and breathe with high-flow nasal cannula
- Primary Outcome Measures
Name Time Method ventilation distribution assessed by EIT 20 minutes Regional ventilation assessed by regional tidal impedance variations relative to global tidal impedance variation (ΔzROI/Δzglobal) obtained by electrical impedance tomography (EIT)
- Secondary Outcome Measures
Name Time Method tidal volume 20 minutes the gas volume during tidal breathing
respiratory rates 20 minutes breathing frequency during tidal breathing
comfort 20 minutes subject's comfort which will be assessed by a 1-10 scale
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States