Trials / Completed
CompletedNCT05512585
A Physiological Study to Assess Awake Prone Positioning and Respiratory Support in Healthy Volunteers
A Physiological Study to Assess the Effects of Awake Prone Positioning in Healthy Volunteers Under Different Respiratory Support: A Randomized Crossover Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) | in this group, healthy subjects will stay in prone position for 20 mins with respiratory support of high-flow nasal cannula or CPAP |
Timeline
- Start date
- 2022-08-28
- Primary completion
- 2022-11-27
- Completion
- 2022-11-27
- First posted
- 2022-08-23
- Last updated
- 2022-12-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05512585. Inclusion in this directory is not an endorsement.