Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure (ProneSpontCov)

Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study

Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: physiological effects of awake prone position in COVID 19 patients

Detailed Description

Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• more than 18 Years (Adult, Older Adult)
• Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)
• Acute respiratory failure with 100 < PaO2:FiO2< 300 mmhg
• Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen
• Written informed consent of the patient

Exclusion Criteria:

• Contra-indication to prone position including pregnancy
• Presence of pacemaker
• Severe hypoxemia with PaO2/FiO2 < 100 mmHg
• Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients in prone position followed by dorsal decubitus; patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.	Other: physiological effects of awake prone position in COVID 19 patients; Study of physiological effects of awake prone position in COVID 19 patients on lung inhomogeneity assessed by Electrical Impedance Tomography (EIT), gas exchange and dyspnea score (Borg Scale). Measurements will be performed at baseline (on supine position), then patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. EIT records will be performed during the last 30 minutes of each period, blood gas and dyspnea score at the end of each period.
Other: dorsal decubitus followed by prone decubitus; patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.	Other: physiological effects of awake prone position in COVID 19 patients; Study of physiological effects of awake prone position in COVID 19 patients on lung inhomogeneity assessed by Electrical Impedance Tomography (EIT), gas exchange and dyspnea score (Borg Scale). Measurements will be performed at baseline (on supine position), then patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. EIT records will be performed during the last 30 minutes of each period, blood gas and dyspnea score at the end of each period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.	Electrical Impedance Tomography (EIT)	2hours

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: jean-olivier ARNAUD, Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• Brunelle T, Prud'homme E, Alphonsine JE, Baumstarck K, Sanz C, Salmi S, Peres N, Forel JM, Papazian L, Hraiech S, Roch A, Guervilly C. Awake prone position in COVID-19 acute respiratory failure: a randomised crossover study using electrical impedance tomography. ERJ Open Res. 2023 Mar 27;9(2):00509-2022. doi: 10.1183/23120541.00509-2022. eCollection 2023 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): November 29, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2020-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No