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

NCT04344106 | Unknown

• 1 other identifier: 20202703-2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• proportion of "persistent responders" patients after prone position

  1 day

• Evolution of PaO2

  1 day

• Duration of prone positioning and PaO2 evolution

  2 days

• Evolution of Spo2

  1 hour

• EVA Dyspnea

  1 day

Study Arms (1)

Prone positioning

EXPERIMENTAL

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

Interventions

Prone positioning PROCEDURE

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.

Prone positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Bilateral scannographic lesions, including posterior condensations and/or posterior predominance of lesions;
• Patient benefiting from French social security, under any regime

You may not qualify if:

• 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.

Sponsors & Collaborators

• ELHARRAR Xavier: lead

Study Sites (1)

CHI Aix-Pertuis

Aix-en-Provence, 13100, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 32189136 BACKGROUND

• 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.

  PMID: 26271685 BACKGROUND

• 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.

  PMID: 32000806 BACKGROUND

• 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.

  PMID: 29068269 BACKGROUND

• 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.

  PMID: 24134414 BACKGROUND

• 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.

  PMID: 23688302 BACKGROUND

• 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.

  PMID: 32105637 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; Hypoxia

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Xavier ELHARRAR, MD

  Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France

  PRINCIPAL INVESTIGATOR

• Youssef Trigui, MD

  Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Xavier ELHARRAR, MD

CONTACT

0442335650; rechercheclinique@ch-aix.fr

Youssef Trigui, MD

CONTACT

0033674215193; rechercheclinique@ch-aix.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: pulmologist

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: April 1, 2020
• Primary Completion: April 15, 2020
• Study Completion: May 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)