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Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress (PROVID-19)

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ClinicalTrials.gov Identifier: NCT04363463
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Brief Summary:

The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS).

The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms.

Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS.

The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.


Condition or disease Intervention/treatment Phase
COVID19 Oxygen Therapy Prone Position Spontaneous Ventilation Respiratory Distress Syndrome Other: prone position Not Applicable

Detailed Description:

This is a multicenter randomized controlled study. 400 patients with COVID-19 documentation and undergoing oxygen therapy will be randomly assigned, with a 1:1 ratio, to conventional positioning or repeated prone sessions.

The control group will have conventional positioning: semi-seated in bed or seated in a chair. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position).

The intervention group will have:

  • Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
  • The maximum of prone position at night. Patients must be able to take position by themselves or with minimal assistance. The rails will be positioned in order to prevent falling out of bed. The patient will be free to choose his preferred prone position as long as the back is not compressed

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled multicenter trial Ratio 1:1
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : August 28, 2022
Estimated Study Completion Date : August 28, 2022


Arm Intervention/treatment
No Intervention: Conventional positioning
semi-seated in bed or seated in a chair during the day. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position).
Experimental: Interventional positioning : prone position
Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
Other: prone position
Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.




Primary Outcome Measures :
  1. Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups. [ Time Frame: Day 28 ]

    To show that PP in spontaneously ventilation patients could reduce the risk of acquiring the following event (composite endpoint):

    • Endotracheal intubation
    • Or non-invasive ventilation (NIV) with two pressure levels
    • And/or death


Secondary Outcome Measures :
  1. Duration in days for the change of 2 points on the WHO ordinal scale [ Time Frame: Day 28 ]
    Show that the use of prone position improves the WHO ordinal scale score by 2 points faster (after randomization)

  2. Rate (%) of intubation and invasive ventilation in the 2 randomization groups. [ Time Frame: Day 28 ]
    Show that prone position with spontaneous ventilation reduces the need for endotracheal intubation and invasive mechanical ventilation

  3. Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups [ Time Frame: Day 28 ]
    Show that prone position with spontaneous ventilation reduces the use of non-invasive ventilation at two pressure levels

  4. Duration of oxygen therapy in the 2 randomization groups. [ Time Frame: Day 28 ]
    Show that prone position in spontaneous ventilation reduces the time under oxygen therapy.

  5. Duration of hospitalization in the 2 randomization groups. [ Time Frame: Day 28 ]
    Show that prone position reduces the length of hospitalization.

  6. Hospital mortality and mortality at D28 in the 2 randomization groups [ Time Frame: Day 28 ]
    Compare the hospital mortality of the 2 groups

  7. Rate (%) of need for transfer to intensive care unit [ Time Frame: Day 28 ]
    Compare the incidence of the need for resuscitation transfer between the two groups.

  8. Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days. [ Time Frame: 1 year ]
    Compare the impact of the use of non-invasive ventilation and intubation on the entire hospital stay when the hospital stay is longer than 28 days between the two groups.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged from 18 to 85 years old
  • With COVID-19 documentation
  • Undergoing oxygen therapy (nasal cannula, medium or high concentration mask or high flow nasal oxygen therapy)
  • Able to move to PP by him/herself or with minimal assistance
  • Written consent
  • Hospitalized in COVID medical department for less than 72 hours

Exclusion Criteria:

  • Pregnant (positive pregnancy test during screening) or breastfeeding women
  • Patient on long-term oxygen therapy or Continuous Positive Airway Pressure (CPAP) or Non-Invasive Ventilation (NIV) at home
  • Chronic Obstructive Pulmonary Disease (COPD) Patient stage 3 or 4
  • Patient with known chronic diffuse interstitial lung disease
  • Patient with neuromuscular pathology
  • Contraindication to the PP (recent thoracic trauma, pneumothorax, orthopaedic fracture preventing mobilization, ...)
  • Deep vein thrombosis of the lower limbs or pulmonary embolism with effective anticoagulation for less than 48 hours
  • Hemodynamic instability (MAP < 65 mm Hg) persisting for more than 1 hour
  • Respiratory rate greater than 40 cycles per minute
  • Excessive use of accessory respiratory muscles (as judged by the clinician)
  • Indication for curative NIV (acute pulmonary edema or acute hypercapnic respiratory failure)
  • Intestinal Occlusive Syndrome
  • Patient unable to protect upper airway
  • Inability to understand French or to follow instructions for the prone position.
  • Person under guardianship
  • Protected Majors
  • Not affiliated to French social security
  • Decision not to forgo life sustaining therapy
  • Patient discharged from an intensive care unit and has been treated by invasive or non-invasive mechanical ventilation at 2 pressure levels during the resuscitation stay.

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): NCT04363463


Contacts
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Contact: Aurélie DESPUJOLS +33238744071 aurelie.despujols@chr-orleans.fr
Contact: Elodie POUGOUE TOUKO +33238744086 elodie.pougoue-touko@chr-orleans.fr

Locations
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France
CH de DAX Not yet recruiting
Dax, France, 40100
Contact: Elsa NYAMANKOLLY, Dr       nyamankollye@ch-dax.fr   
Principal Investigator: Elsa NYAMANKOLLY         
CHD de VENDEE Recruiting
La Roche sur Yon, France, 85925
Contact: Marine MORIER, Dr       marine.morrier@chd-vendee.fr   
Principal Investigator: MARINE MORIER         
CH de LA ROCHELLE Recruiting
La Rochelle, France, 17019
Contact: Xavier POUGET-ABADIE, Dr       xpougetabadie@yahoo.fr   
Principal Investigator: Xavier POUGET-ABADIE         
CHR d'Orléans - Service Pneumologie Recruiting
Orléans, France, 45000
Contact: Sylvie DRUELLE, Dr       sylvie.druelle@chr-orleans.fr   
Principal Investigator: Sylvie DRUELLE         
CHR d'Orleans - Service Maladies Infectieuses Recruiting
Orléans, France, 45067
Contact: Aymeric SEVE, Dr       aymeric.seve@chr-orleans.fr   
Principal Investigator: Aymeric SEVE, Dr         
HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition Not yet recruiting
Paris, France, 75010
Contact: Jean-François GAUTIER, Pr       jean-francois.gautier@aphp.fr   
Principal Investigator: Jean-François GAUTIER, Pr         
Hopital Européen Georges Pompidou Recruiting
Paris, France
Contact: Benjamin PLANQUETTE, Dr       benjamin.planquette@aphp.fr   
Principal Investigator: Benjamin PLANQUETTE, Dr         
Hopital Lariboisiere - Medecine Interne Not yet recruiting
Paris, France
Contact: Amanda LOPES, Dr       amanda.lopes@aphp.fr   
Principal Investigator: Amanda LOPES, Dr         
Hopital Lariboisiere Not yet recruiting
Paris, France
Contact: Pierre SELLIER, Pr       pierre.sellier@aphp.fr   
Principal Investigator: Pierre SELLIER, Pr         
CH de PERPIGNAN - Service Maladies infectieuses Not yet recruiting
Perpignan, France, 66046
Contact: Léa COLOMBAIN, Dr       lea.colombain@ch-perpignan.fr   
Principal Investigator: Léa COLOMBAIN, Dr         
CH de Perpignan - pneumologie Not yet recruiting
Perpignan, France
Contact: Léa COLOMBAIN, Dr       lea.colombain@ch-perpignan.fr   
Principal Investigator: Léa COLOMBAIN, Dr         
Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau Recruiting
Quimper, France, 29000
Contact: Nicolas BIZIEN, Dr       n.bizien@ch-cornouaille.fr   
Principal Investigator: Nicolas BIZIEN, Dr         
CHRU de Tours - Service Médecine interne et immunologie Clinique Not yet recruiting
Tours, France, 37000
Contact: François MAILLOT, Pr       francois.maillot@univ-tours.fr   
Principal Investigator: François MAILLOT, Pr         
CHRU de Tours - Service Pneumologie Not yet recruiting
Tours, France, 37000
Contact: Laurent PLANTIER, Pr       laurent.plantier@univ-tours.fr   
Principal Investigator: Laurent PLANTIER, Pr         
CHRU DE TOURS - Service Médecine interne et maladies infectieuses Not yet recruiting
Tours, France, 37044
Contact: Louis BERNARD, Pr       l.bernard@chu-tours.fr   
Principal Investigator: Louis BERNARD, Pr         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Study Chair: Mai-Anh NAY, Dr CHR Orléans
Publications:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04363463    
Other Study ID Numbers: CHRO-2020-09
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
COVID19
Oxygen therapy
Prone position
Spontaneous ventilation
Acute respiratory failure
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases