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A Physiological Study to Assess Awake Prone Positioning and Respiratory Support in Healthy Volunteers

NCT05512585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-09

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Jie Li, PhD · Rush University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-28
Primary Completion
2022-11-27
Completion
2022-11-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512585 on ClinicalTrials.gov