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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    20
  • sponsor
    Rush University Medical Center
Updated on 7 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition Healthy
Treatment awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure)
Clinical Study IdentifierNCT05512585
SponsorRush University Medical Center
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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