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

NCT04632602 | Completed

• 1 other identifier: 2020-17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.

  Electrical Impedance Tomography (EIT)

  2hours

Study Arms (2)

patients in prone position followed by dorsal decubitus

OTHER

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

dorsal decubitus followed by prone decubitus

OTHER

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

Interventions

physiological effects of awake prone position in COVID 19 patients OTHER

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.

dorsal decubitus followed by prone decubitus; patients in prone position followed by dorsal decubitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Höpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• 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.

  PMID: 36994452 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jean-Olivier ARNAUD

  ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be his own control. The order of the experimental periods will be: 1. arm A: prone position followed by dorsal decubitus 2. arm B: dorsal decubitus followed by ventral decubitus A 30-minute wash-out period is set between the end of sequence 1 and the start of sequence 2.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 17, 2020
• Study Start: April 14, 2020
• Primary Completion: November 29, 2020
• Study Completion: December 31, 2020
• Last Updated: May 8, 2026

Record last verified: 2021-08

Locations

FR (1)