Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)
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|ClinicalTrials.gov Identifier: NCT04344106|
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection Oxygen Deficiency||Procedure: Prone positioning||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||April 15, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: 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.
Procedure: Prone positioning
The prone positioning consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day.
- Proportion of "responder" patients to prone position [ Time Frame: 1 hour ]PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.
- proportion of "persistent responders" patients after prone position [ Time Frame: 1 day ]PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.
- Evolution of PaO2 [ Time Frame: 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 [ Time Frame: 2 days ]Look for an association between the time spent in Prone positione and persistent responder or not;
- Evolution of Spo2 [ Time Frame: 1 hour ]proportion of patients improving their arterial saturation within 1 hour of Prone Position
- EVA Dyspnea [ Time Frame: 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 [ Time Frame: 1 day ]proportion of patients intolerant to prone position (Prone Position <1h);
- Tolerance to prone positioning [ Time Frame: 1 day ]proportion of patients who can maintain prone position for more than 3 h.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344106
|Contact: Xavier ELHARRAR, MD||0442335650 ext +firstname.lastname@example.org|
|Contact: Youssef Trigui, MDemail@example.com|
|Aix-en-Provence, France, 13100|
|Contact: Xavier ELHARRAR 0442335650 ext +33 firstname.lastname@example.org|
|Principal Investigator:||Xavier ELHARRAR, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Director:||Youssef Trigui, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Chair:||Stephanie Martinez, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Chair:||Laurence Maulin, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Chair:||Marie Bernardi, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Chair:||Laurent Lefebvre, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Chair:||Thibaut Helbert, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|
|Study Chair:||Camille begne, MD||Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France|