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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Other: physiological effects of awake prone position in COVID 19 patients

• Registration Number: NCT04632602
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

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 Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-17
• Primary Completion: 2020-11-29
• Study Completion: 2020-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
patients in prone position followed by dorsal decubitus	physiological effects of awake prone position in COVID 19 patients	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.
dorsal decubitus followed by prone decubitus	physiological effects of awake prone position in COVID 19 patients	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assistance Publique Höpitaux de Marseille; 🇫🇷 Marseille, France