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

Sponsor

Centre Hospitalier Régional d'Orléans (Other)

Overall Status

Recruiting

CT.gov ID

NCT04363463

Collaborator

(none)

268

Enrollment

Locations

Arms

Anticipated Duration (Months)

14.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

268 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled multicenter trial Ratio 1:1Randomized 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 :

Aug 28, 2020

Anticipated Primary Completion Date :

Aug 28, 2022

Anticipated Study Completion Date :

Aug 28, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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. [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

Duration in days for the change of 2 points on the WHO ordinal scale [Day 28]
Show that the use of prone position improves the WHO ordinal scale score by 2 points faster (after randomization)
Rate (%) of intubation and invasive ventilation in the 2 randomization groups. [Day 28]
Show that prone position with spontaneous ventilation reduces the need for endotracheal intubation and invasive mechanical ventilation
Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups [Day 28]
Show that prone position with spontaneous ventilation reduces the use of non-invasive ventilation at two pressure levels
Duration of oxygen therapy in the 2 randomization groups. [Day 28]
Show that prone position in spontaneous ventilation reduces the time under oxygen therapy.
Duration of hospitalization in the 2 randomization groups. [Day 28]
Show that prone position reduces the length of hospitalization.
Hospital mortality and mortality at D28 in the 2 randomization groups [Day 28]
Compare the hospital mortality of the 2 groups
Rate (%) of need for transfer to intensive care unit [Day 28]
Compare the incidence of the need for resuscitation transfer between the two groups.
Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH de Blois	Blois	France	41016
2	CH de DAX	Dax	France	40100
3	CHD de VENDEE	La Roche sur Yon	France	85925
4	CH de LA ROCHELLE	La Rochelle	France	17019
5	CH Le Mans	Le Mans	France	72037
6	CH Mont de MArsan	Mont-de-Marsan	France	40012
7	CHR d'Orléans - Service Pneumologie	Orléans	France	45000
8	CHR d'Orleans - Service Maladies Infectieuses	Orléans	France	45067
9	HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition	Paris	France	75010
10	Hopital Européen Georges Pompidou	Paris	France
11	Hopital Lariboisiere - Medecine Interne	Paris	France
12	Hopital Lariboisiere	Paris	France
13	CH de PERPIGNAN - Service Maladies infectieuses	Perpignan	France	66046
14	Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau	Quimper	France	29000
15	CHRU de Tours - Service Médecine interne et immunologie Clinique	Tours	France	37000
16	CHRU de Tours - Service Pneumologie	Tours	France	37000
17	CHRU DE TOURS - Service Médecine interne et maladies infectieuses	Tours	France	37044
18	CH Bretagne Atlantique	Vannes	France	56017
19	centre Hospitalier Princesse Grace	Monaco	Monaco