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

NCT05512585 | Completed

• 1 other identifier: APP-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ventilation distribution assessed by EIT

  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 Outcomes (3)

• tidal volume

  20 minutes

• respiratory rates

  20 minutes

• comfort

  20 minutes

Study Arms (6)

awake prone positioning with room air

ACTIVE COMPARATOR

Participants will stay in the prone position

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

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)

awake prone positioning with continuous positive airway pressure

EXPERIMENTAL

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)

supine position with room air

NO INTERVENTION

Participants will stay in the supine position

supine position with high-flow nasal cannula

ACTIVE COMPARATOR

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)

supine position with continuous positive airway pressure

ACTIVE COMPARATOR

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)

Interventions

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

awake prone positioning with continuous positive airway pressure; awake prone positioning with high-flow nasal cannula; awake prone positioning with room air; supine position with continuous positive airway pressure; supine position with high-flow nasal cannula

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults aged between 21 to 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028.

  PMID: 35072713 BACKGROUND

• Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.

  PMID: 28762180 BACKGROUND

• Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.

  PMID: 23050520 BACKGROUND

• Chiumello D, Chiodaroli E, Coppola S, Cappio Borlino S, Granata C, Pitimada M, Wendel Garcia PD. Awake prone position reduces work of breathing in patients with COVID-19 ARDS supported by CPAP. Ann Intensive Care. 2021 Dec 20;11(1):179. doi: 10.1186/s13613-021-00967-6.

  PMID: 34928455 BACKGROUND

• Liu L, Xie J, Wang C, Zhao Z, Chong Y, Yuan X, Qiu H, Zhao M, Yang Y, Slutsky AS. Prone position improves lung ventilation-perfusion matching in non-intubated COVID-19 patients: a prospective physiologic study. Crit Care. 2022 Jun 29;26(1):193. doi: 10.1186/s13054-022-04069-y. No abstract available.

  PMID: 35768877 BACKGROUND

• Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.

  PMID: 34425070 RESULT

• Li J, Luo J, Pavlov I, Perez Y, Tan W, Roca O, Tavernier E, Kharat A, McNicholas B, Ibarra-Estrada M, Vines DL, Bosch NA, Rampon G, Simpson SQ, Walkey AJ, Fralick M, Verma A, Razak F, Harris T, Laffey JG, Guerin C, Ehrmann S; Awake Prone Positioning Meta-Analysis Group. Awake prone positioning for non-intubated patients with COVID-19-related acute hypoxaemic respiratory failure: a systematic review and meta-analysis. Lancet Respir Med. 2022 Jun;10(6):573-583. doi: 10.1016/S2213-2600(22)00043-1. Epub 2022 Mar 16.

  PMID: 35305308 RESULT

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jie Li, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 23, 2022
• Study Start: August 28, 2022
• Primary Completion: November 27, 2022
• Study Completion: November 27, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)