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)

December 27, 2022 updated by: Centre Hospitalier Régional d'Orléans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Blois, France, 41016
        • CH DE BLOIS
      • Dax, France, 40100
        • CH de Dax
      • La Roche sur Yon, France, 85925
        • CHD de Vendée
      • La Rochelle, France, 17019
        • CH de la Rochelle
      • Le Mans, France, 72037
        • CH Le Mans
      • Mont-de-Marsan, France, 40012
        • CH Mont de Marsan
      • Orléans, France, 45000
        • CHR d'Orléans - Service Pneumologie
      • Orléans, France, 45067
        • CHR d'Orleans - Service Maladies Infectieuses
      • Paris, France
        • Hopital Lariboisiere
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75010
        • HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition
      • Paris, France
        • Hopital Lariboisiere - Medecine Interne
      • Perpignan, France, 66046
        • CH de PERPIGNAN - Service Maladies infectieuses
      • Quimper, France, 29000
        • Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau
      • Tours, France, 37000
        • CHRU de Tours - Service Médecine interne et immunologie Clinique
      • Tours, France, 37000
        • CHRU de Tours - Service Pneumologie
      • Tours, France, 37044
        • CHRU DE TOURS - Service Médecine interne et maladies infectieuses
      • Vannes, France, 56017
        • CH Bretagne Atlantique
  • Monaco
      • Monaco, Monaco
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 28
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
Day 28
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
Day 28
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.
Day 28
Duration of hospitalization in the 2 randomization groups.
Time Frame: Day 28
Show that prone position reduces the length of hospitalization.
Day 28
Hospital mortality and mortality at D28 in the 2 randomization groups
Time Frame: Day 28
Compare the hospital mortality of the 2 groups
Day 28
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.
Day 28
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Study Chair: Mai-Anh NAY, Dr, CHR Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2020

Primary Completion (Actual)

January 13, 2022

Study Completion (Actual)

January 13, 2022

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Estimate)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2020-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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