awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rush University Medical Center, Chicago, IL
Healthy Subjects (HS)+3 More
awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) - Other
Eligibility
18+
All Sexes
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Study 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.

Eligible Conditions

  • Healthy Subjects (HS)
  • High Flow Nasal Cannula
  • Awake Prone Positioning
  • Continuous Positive Airway Pressure (CPAP)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 20 minutes

20 minutes
comfort
respiratory rates
tidal volume
ventilation distribution assessed by EIT

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

supine position with continuous positive airway pressure
1 of 6
supine position with room air
1 of 6
awake prone positioning with room air
1 of 6
supine position with high-flow nasal cannula
1 of 6
awake prone positioning with high-flow nasal cannula
1 of 6
awake prone positioning with continuous positive airway pressure
1 of 6
Active Control
Experimental Treatment

20 Total Participants · 6 Treatment Groups

Primary Treatment: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) · No Placebo Group · N/A

awake prone positioning with high-flow nasal cannula
Other
Experimental Group · 1 Intervention: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) · Intervention Types: Other
awake prone positioning with continuous positive airway pressure
Other
Experimental Group · 1 Intervention: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) · Intervention Types: Other
supine position with continuous positive airway pressure
Other
ActiveComparator Group · 1 Intervention: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) · Intervention Types: Other
supine position with room airNoIntervention Group · 1 Intervention: supine position with room air · Intervention Types:
awake prone positioning with room air
Other
ActiveComparator Group · 1 Intervention: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) · Intervention Types: Other
supine position with high-flow nasal cannula
Other
ActiveComparator Group · 1 Intervention: awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure) · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 minutes
Closest Location: Rush University Medical Center · Chicago, IL
Photo of rush university medical center 1Photo of rush university medical center 2Photo of rush university medical center 3
2011First Recorded Clinical Trial
2 TrialsResearching Healthy Subjects (HS)
793 CompletedClinical Trials

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
377 Previous Clinical Trials
151,952 Total Patients Enrolled
Jie Li, PhDPrincipal InvestigatorRush University
9 Previous Clinical Trials
416 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References