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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
Sponsor:
Information provided by (Responsible Party):
ELHARRAR Xavier, Centre Hospitalier Intercommunal Aix-Pertuis

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Oxygen Deficiency Procedure: Prone positioning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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;

  4. Evolution of Spo2 [ Time Frame: 1 hour ]
    proportion of patients improving their arterial saturation within 1 hour of Prone Position

  5. 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

  6. Intolerance to prone positioning [ Time Frame: 1 day ]
    proportion of patients intolerant to prone position (Prone Position <1h);

  7. Tolerance to prone positioning [ Time Frame: 1 day ]
    proportion of patients who can maintain prone position for more than 3 h.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Xavier ELHARRAR, MD 0442335650 ext +33 rechercheclinique@ch-aix.fr
Contact: Youssef Trigui, MD 0033674215193 rechercheclinique@ch-aix.fr

Locations
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France
CHI Aix-Pertuis Recruiting
Aix-en-Provence, France, 13100
Contact: Xavier ELHARRAR    0442335650 ext +33    rechercheclinique@ch-aix.fr   
Sponsors and Collaborators
ELHARRAR Xavier
Investigators
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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:

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Responsible Party: ELHARRAR Xavier, pulmologist, Centre Hospitalier Intercommunal Aix-Pertuis
ClinicalTrials.gov Identifier: NCT04344106    
Other Study ID Numbers: 20202703-2
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Hypoxia
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms