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Completed

NCT Number: NCT05512585

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

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

in this group, healthy subjects will stay in prone position for 20 mins with respiratory support of high-flow nasal cannula or CPAP

Primary outcomes

  1. 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)

Secondary outcomes

  1. tidal volume

    Time frame: 20 minutes

    the gas volume during tidal breathing

  2. respiratory rates

    Time frame: 20 minutes

    breathing frequency during tidal breathing

  3. comfort

    Time frame: 20 minutes

    subject's comfort which will be assessed by a 1-10 scale

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2022
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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