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

NCT ID: NCT05512585

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-28

Study Completion Date

2022-11-27

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Prone positioning high-flow nasal cannula continuous positive airway pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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awake prone positioning with room air

Participants will stay in the prone position

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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 high-flow nasal cannula

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

Group Type EXPERIMENTAL

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

Intervention Type 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

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

supine position with room air

Participants will stay in the supine position

Group Type NO_INTERVENTION

No interventions assigned to this group

supine position with high-flow nasal cannula

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

supine position with continuous positive airway pressure

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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awake 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35072713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28762180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23050520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34928455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35768877 (View on PubMed)

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.

Reference Type RESULT
PMID: 34425070 (View on PubMed)

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.

Reference Type RESULT
PMID: 35305308 (View on PubMed)

Other Identifiers

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APP-002

Identifier Type: -

Identifier Source: org_study_id