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

Primary Purpose

Coronavirus Infection, Oxygen Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prone positioning
Sponsored by
ELHARRAR Xavier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronavirus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHI Aix-PertuisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prone positioning

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2020
Last Updated
April 10, 2020
Sponsor
ELHARRAR Xavier
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1. Study Identification

Unique Protocol Identification Number
NCT04344106
Brief Title
Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study
Acronym
ProCov
Official Title
Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ELHARRAR Xavier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Oxygen Deficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prone positioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prone positioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of "responder" patients to prone position
Description
PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
proportion of "persistent responders" patients after prone position
Description
PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.
Time Frame
1 day
Title
Evolution of PaO2
Description
PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.
Time Frame
1 day
Title
Duration of prone positioning and PaO2 evolution
Description
Look for an association between the time spent in Prone positione and persistent responder or not;
Time Frame
2 days
Title
Evolution of Spo2
Description
proportion of patients improving their arterial saturation within 1 hour of Prone Position
Time Frame
1 hour
Title
EVA Dyspnea
Description
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
Time Frame
1 day
Title
Intolerance to prone positioning
Description
proportion of patients intolerant to prone position (Prone Position <1h);
Time Frame
1 day
Title
Tolerance to prone positioning
Description
proportion of patients who can maintain prone position for more than 3 h.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier ELHARRAR, MD
Phone
0442335650
Ext
+33
Email
rechercheclinique@ch-aix.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Youssef Trigui, MD
Phone
0033674215193
Email
rechercheclinique@ch-aix.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier ELHARRAR, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youssef Trigui, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephanie Martinez, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laurence Maulin, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marie Bernardi, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laurent Lefebvre, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thibaut Helbert, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Camille begne, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France
Official's Role
Study Chair
Facility Information:
Facility Name
CHI Aix-Pertuis
City
Aix-en-Provence
ZIP/Postal Code
13100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier ELHARRAR
Phone
0442335650
Ext
+33
Email
rechercheclinique@ch-aix.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32189136
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.
Results Reference
background
PubMed Identifier
26271685
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.
Results Reference
background
PubMed Identifier
32000806
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.
Results Reference
background
PubMed Identifier
29068269
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.
Results Reference
background
PubMed Identifier
24134414
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.
Results Reference
background
PubMed Identifier
23688302
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.
Results Reference
background
PubMed Identifier
32105637
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.
Results Reference
background

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

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