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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infection; Oxygen Deficiency
• Intervention / Treatment: Procedure: Prone positioning

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xavier ELHARRAR, MD; Phone Number: +33 0442335650; Email: rechercheclinique@ch-aix.fr
• Study Contact Backup: Name: Youssef Trigui, MD; Phone Number: 0033674215193; Email: rechercheclinique@ch-aix.fr

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Recruiting
    • CHI Aix-Pertuis
    • Contact: Xavier ELHARRAR; Phone Number: +33 0442335650; Email: rechercheclinique@ch-aix.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ELHARRAR Xavier
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): April 15, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Respiratory; Coronavirus Infections; Hypoxia
• Other Study ID Numbers: 20202703-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No