Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study

Not Applicable

• Conditions: Coronavirus Infection; Oxygen Deficiency
• Interventions: Procedure: Prone positioning

• Registration Number: NCT04344106
• Lead Sponsor: ELHARRAR Xavier

Brief Summary

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

Detailed Description

SARS-CoV-2 is an RNA virus whose tropism for the respiratory system is responsible for many cases of acute respiratory failure. This can lead to acute respiratory distress syndrome (ARDS) requiring orotracheal intubation and mechanical ventilation. The prone position is a validated intensive care technique in the treatment of ARDS in mechanically ventilated patients. Performing prone position sessions improves patient oxygenation by optimizing the ventilation/perfusion ratios of the posterior areas of the lungs.

There is limited data in the literature on the ventral decubitus in spontaneous ventilation. They are mainly case series or retrospective studies. In the case of the SARS-CoV-2 epidemic, we are seeing patients with posterior lung involvement who may benefit from prone position sessions prior to mechanical ventilation. This maneuver, usually done in an intubated-ventilated-curarized patient, will be done in our spontaneous ventilation study in a conscious patient.The patient will then be placed in prone position with the help of physiotherapists so that the patient is correctly positioned.

The maneuver and the clinical monitoring of the patient's tolerance to the prone position will be done under medical and paramedical supervision, including monitoring of saturation during and after the procedure. A polygraph will also be installed on the patient in order to monitor the patient's position (on the back vs. on the stomach), saturation and heart rate during the entire prone position session. An arterial gasometry will be performed before the patient is placed in the prone position, one hour after and after returning to the supine position.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-01
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-04-15
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patient aged at least 18 years;
• Hospitalized in a COVID unit or intensive care unit;
• Spontaneously breathing and with oxygen therapy with nasal canula, mask or High Flow Oxygen Therapy;
• Requiring oxygen therapy ≥ 1l for Sat ≥ 90%;
• COVID 19 positive in RT-PCR or diagnosis on clinicals symptoms and highly evocatives scannographics lesions in an epidemic period;
• Chest scanner without injection within 72 hours prior to inclusion;
• Bilateral scannographic lesions, including posterior condensations and/or posterior predominance of lesions;
• Patient benefiting from French social security, under any regime

Exclusion Criteria

• acute respiratory distress (polypnea >25 or use of accessory respiratory muscles);
• Alteration of consciousness;
• Active or recent hemoptysis (<1 month);
• Recent Thrombo-Embolic Venous Disease (< 1 month);
• Pericardial effusion;
• Pleural effusion of high abundance, clinical or scannographic;
• Chronic back or cervical pain/ history of spinal surgery/ bone metastases;
• Wounds, facial trauma, tracheal, sternal or facial surgery < 15 days;
• Recent abdominal surgery (< 1 month);
• Intracranial HyperTension > 30mmHg;
• Patient deprived of liberty, under guardianship or curatorship;
• Pregnant or lactating woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prone positioning	Prone positioning	Participants are all turned to prone position for an optimal minimum duration of 3 hours . Tolerance, oxygen saturation, heart rate and position are monitoring during all procedure. Arterial blood gases are realized before, 1 to 2 hours after the beginning of the prone position, and 6 to 12 hours after resupination.

Primary Outcome Measures

Name	Time	Method
Proportion of "responder" patients to prone position	1 hour	PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.

Secondary Outcome Measures

Name	Time	Method
proportion of "persistent responders" patients after prone position	1 day	PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.
Evolution of PaO2	1 day	PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.
Duration of prone positioning and PaO2 evolution	2 days	Look for an association between the time spent in Prone positione and persistent responder or not;
Evolution of Spo2	1 hour	proportion of patients improving their arterial saturation within 1 hour of Prone Position
EVA Dyspnea	1 day	evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position
Intolerance to prone positioning	1 day	proportion of patients intolerant to prone position (Prone Position \<1h);
Tolerance to prone positioning	1 day	proportion of patients who can maintain prone position for more than 3 h.

Trial Locations

Locations (1)

CHI Aix-Pertuis; 🇫🇷 Aix-en-Provence, France