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

Rush

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05512585

APP-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 6 patient groups

awake prone positioning with room air

Active Comparator group

Description:

Participants will stay in the prone position

Treatment:

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

awake prone positioning with high-flow nasal cannula

Experimental group

Description:

Participants will stay in the prone position and breathe with high-flow nasal cannula

Treatment:

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

awake prone positioning with continuous positive airway pressure

Experimental group

Description:

Participants will stay in the prone position and breathe with continuous positive airway pressure via face mask

Treatment:

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

supine position with room air

No Intervention group

Description:

Participants will stay in the supine position

supine position with high-flow nasal cannula

Active Comparator group

Description:

Participants will stay in the supine position and breathe with high-flow nasal cannula

Treatment:

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

supine position with continuous positive airway pressure

Active Comparator group

Description:

Participants will stay in the supine position and breathe with continuous positive airway pressure via face mask

Treatment:

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