Clinical trial NCT04344106: Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study
Official title: Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Infection
Oxygen Deficiency
Lead sponsor: Centre Hospitalier Intercommunal Aix-Pertuis
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of "responder" patients to prone position
timeFrame: 1 hour
Secondary outcomes:
measure: proportion of "persistent responders" patients after prone position
timeFrame: 1 day
measure: Evolution of PaO2
timeFrame: 1 day
measure: Duration of prone positioning and PaO2 evolution
timeFrame: 2 days
measure: Evolution of Spo2
timeFrame: 1 hour
measure: EVA Dyspnea
timeFrame: 1 day
measure: Intolerance to prone positioning
timeFrame: 1 day
measure: Tolerance to prone positioning
timeFrame: 1 day
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CHI Aix-Pertuis
Study officials:
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Xavier ELHARRAR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Youssef Trigui, MD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Stephanie Martinez, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Laurence Maulin, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Marie Bernardi, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Laurent Lefebvre, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Thibaut Helbert, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
name: Camille begne, MD
role: STUDY_CHAIR
References:
citation: Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.
citation: Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.
citation: Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
citation: Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.
citation: Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
citation: Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
citation: Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.