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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)

Primary Purpose

COVID19, Oxygen Therapy, Prone Position

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
prone position
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID19 focused on measuring COVID19, Oxygen therapy, Prone position, Spontaneous ventilation, Acute respiratory failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CH de Blois
  • CH de DAX
  • CHD de VENDEE
  • CH de LA ROCHELLE
  • CH Le Mans
  • CH Mont de MArsan
  • CHR d'Orléans - Service Pneumologie
  • CHR d'Orleans - Service Maladies Infectieuses
  • HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition
  • Hopital Européen Georges Pompidou
  • Hopital Lariboisiere - Medecine Interne
  • Hopital Lariboisiere
  • CH de PERPIGNAN - Service Maladies infectieuses
  • Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau
  • CHRU de Tours - Service Médecine interne et immunologie Clinique
  • CHRU de Tours - Service Pneumologie
  • CHRU DE TOURS - Service Médecine interne et maladies infectieuses
  • CH Bretagne Atlantique
  • centre Hospitalier Princesse Grace

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional positioning

Interventional positioning : prone position

Arm Description

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).

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.

Outcomes

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.
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
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.
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
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.
Show that prone position in spontaneous ventilation reduces the time under oxygen therapy.
Duration of hospitalization in the 2 randomization groups.
Show that prone position reduces the length of hospitalization.
Hospital mortality and mortality at D28 in the 2 randomization groups
Compare the hospital mortality of the 2 groups
Rate (%) of need for transfer to intensive care unit
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.
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.

Full Information

First Posted
April 22, 2020
Last Updated
December 27, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT04363463
Brief 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
Acronym
PROVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

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

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Oxygen Therapy, Prone Position, Spontaneous Ventilation, Respiratory Distress Syndrome
Keywords
COVID19, Oxygen therapy, Prone position, Spontaneous ventilation, Acute respiratory failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled multicenter trial Ratio 1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional positioning
Arm Type
No Intervention
Arm Description
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).
Arm Title
Interventional positioning : prone position
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
prone position
Intervention Description
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 Measure Information:
Title
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.
Description
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
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Duration in days for the change of 2 points on the WHO ordinal scale
Description
Show that the use of prone position improves the WHO ordinal scale score by 2 points faster (after randomization)
Time Frame
Day 28
Title
Rate (%) of intubation and invasive ventilation in the 2 randomization groups.
Description
Show that prone position with spontaneous ventilation reduces the need for endotracheal intubation and invasive mechanical ventilation
Time Frame
Day 28
Title
Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups
Description
Show that prone position with spontaneous ventilation reduces the use of non-invasive ventilation at two pressure levels
Time Frame
Day 28
Title
Duration of oxygen therapy in the 2 randomization groups.
Description
Show that prone position in spontaneous ventilation reduces the time under oxygen therapy.
Time Frame
Day 28
Title
Duration of hospitalization in the 2 randomization groups.
Description
Show that prone position reduces the length of hospitalization.
Time Frame
Day 28
Title
Hospital mortality and mortality at D28 in the 2 randomization groups
Description
Compare the hospital mortality of the 2 groups
Time Frame
Day 28
Title
Rate (%) of need for transfer to intensive care unit
Description
Compare the incidence of the need for resuscitation transfer between the two groups.
Time Frame
Day 28
Title
Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Anh NAY, Dr
Organizational Affiliation
CHR Orléans
Official's Role
Study Chair
Facility Information:
Facility Name
CH de Blois
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
CH de DAX
City
Dax
ZIP/Postal Code
40100
Country
France
Facility Name
CHD de VENDEE
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH de LA ROCHELLE
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
CH Mont de MArsan
City
Mont-de-Marsan
ZIP/Postal Code
40012
Country
France
Facility Name
CHR d'Orléans - Service Pneumologie
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
CHR d'Orleans - Service Maladies Infectieuses
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
Hopital Lariboisiere - Medecine Interne
City
Paris
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
Country
France
Facility Name
CH de PERPIGNAN - Service Maladies infectieuses
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
CHRU de Tours - Service Médecine interne et immunologie Clinique
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CHRU de Tours - Service Pneumologie
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CHRU DE TOURS - Service Médecine interne et maladies infectieuses
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CH Bretagne Atlantique
City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
centre Hospitalier Princesse Grace
City
Monaco
Country
Monaco

12. IPD Sharing Statement

Citations:
PubMed Identifier
32159735
Citation
Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.
Results Reference
background
PubMed Identifier
31986264
Citation
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
Results Reference
background
PubMed Identifier
32171076
Citation
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
Results Reference
background
PubMed Identifier
32167524
Citation
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.
Results Reference
background
PubMed Identifier
35803621
Citation
Nay MA, Planquette B, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Bernard L, Nyamankolly E, Fossat G, Boulain T. Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol. BMJ Open. 2022 Jul 8;12(7):e060320. doi: 10.1136/bmjopen-2021-060320.
Results Reference
derived

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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

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