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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT04632602
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Other: physiological effects of awake prone position in COVID 19 patients	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each patient will be his own control. The order of the experimental periods will be: arm A: prone position followed by dorsal decubitus 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.Each patient will be his own control. The order of the experimental periods will be:arm A: prone position followed by dorsal decubitus 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.
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study
• Actual Study Start Date: Apr 14, 2020
• Actual Primary Completion Date: Nov 29, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods. [2hours]

   Electrical Impedance Tomography (EIT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Höpitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: Jean-Olivier ARNAUD, ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT04632602
• Other Study ID Numbers: 2020-17
• First Posted: Nov 17, 2020
• Last Update Posted: Aug 13, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Aug 13, 2021