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

December 8, 2022 updated by: Jie Li, Rush University Medical Center

A Physiological Study to Assess the Effects of Awake Prone Positioning in Healthy Volunteers Under Different Respiratory Support: A Randomized Crossover Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

healthy adults aged between 21 to 65 years

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: awake prone positioning with room air
Participants will stay in the prone position
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
Experimental: awake prone positioning with high-flow nasal cannula
Participants will stay in the prone position and breathe with high-flow nasal cannula
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
Experimental: 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
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
No Intervention: supine position with room air
Participants will stay in the supine position
Active Comparator: supine position with high-flow nasal cannula
Participants will stay in the supine position and breathe with high-flow nasal cannula
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
Active Comparator: supine position with continuous positive airway pressure
Participants will stay in the supine position and breathe with continuous positive airway pressure via face mask
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventilation distribution assessed by EIT
Time Frame: 20 minutes
Regional ventilation assessed by regional tidal impedance variations relative to global tidal impedance variation (ΔzROI/Δzglobal) obtained by electrical impedance tomography (EIT)
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tidal volume
Time Frame: 20 minutes
the gas volume during tidal breathing
20 minutes
respiratory rates
Time Frame: 20 minutes
breathing frequency during tidal breathing
20 minutes
comfort
Time Frame: 20 minutes
subject's comfort which will be assessed by a 1-10 scale
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2022

Primary Completion (Actual)

November 27, 2022

Study Completion (Actual)

November 27, 2022

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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