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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05512585
Enrollment
20
Registered
2022-08-23
Start date
2022-08-28
Completion date
2022-11-27
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Prone positioning, high-flow nasal cannula, continuous positive airway pressure

Brief 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.

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.

Interventions

OTHERawake 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

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ventilation distribution assessed by EIT20 minutesRegional ventilation assessed by regional tidal impedance variations relative to global tidal impedance variation (ΔzROI/Δzglobal) obtained by electrical impedance tomography (EIT)

Secondary

MeasureTime frameDescription
tidal volume20 minutesthe gas volume during tidal breathing
respiratory rates20 minutesbreathing frequency during tidal breathing
comfort20 minutessubject's comfort which will be assessed by a 1-10 scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026