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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2022-01-13

Brief Summary

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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

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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

Conditions

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COVID19 Oxygen Therapy Prone Position Spontaneous Ventilation Respiratory Distress Syndrome

Keywords

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COVID19 Oxygen therapy Prone position Spontaneous ventilation Acute respiratory failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled multicenter trial Ratio 1:1

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

prone position

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mai-Anh NAY, Dr

Role: STUDY_CHAIR

CHR Orléans

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France Monaco

Reference Type DERIVED

PMID: 35803621 (View on PubMed)

Other Identifiers

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CHRO-2020-09

Identifier Type: -

Identifier Source: org_study_id

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 Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Conventional positioning

Interventional positioning : prone position

prone position

Interventions

prone position

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Centre Hospitalier Régional d'Orléans

Responsible Party

Principal Investigators

Mai-Anh NAY, Dr

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

Countries

References

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.

Other Identifiers

CHRO-2020-09