Clinical trial NCT04363463: Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress
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
Overall status: COMPLETED
Phase: NA
Conditions: COVID19
Oxygen Therapy
Prone Position
Spontaneous Ventilation
Respiratory Distress Syndrome
Keywords: COVID19
Oxygen therapy
Prone position
Spontaneous ventilation
Acute respiratory failure
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled multicenter trial Ratio 1:1
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: 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.
timeFrame: Day 28
Secondary outcomes:
measure: Duration in days for the change of 2 points on the WHO ordinal scale
timeFrame: Day 28
measure: Rate (%) of intubation and invasive ventilation in the 2 randomization groups.
timeFrame: Day 28
measure: Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups
timeFrame: Day 28
measure: Duration of oxygen therapy in the 2 randomization groups.
timeFrame: Day 28
measure: Duration of hospitalization in the 2 randomization groups.
timeFrame: Day 28
measure: Hospital mortality and mortality at D28 in the 2 randomization groups
timeFrame: Day 28
measure: Rate (%) of need for transfer to intensive care unit
timeFrame: Day 28
measure: Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days.
timeFrame: 1 year
Other outcomes:
Locations:
city: Blois
country: France
facility: CH de Blois
city: Dax
country: France
facility: CH de DAX
city: La Roche sur Yon
country: France
facility: CHD de VENDEE
city: La Rochelle
country: France
facility: CH de LA ROCHELLE
city: Le Mans
country: France
facility: CH Le Mans
city: Mont-de-Marsan
country: France
facility: CH Mont de MArsan
city: Orléans
country: France
facility: CHR d'Orléans - Service Pneumologie
city: Orléans
country: France
facility: CHR d'Orleans - Service Maladies Infectieuses
city: Paris
country: France
facility: HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Paris
country: France
facility: Hopital Lariboisiere - Medecine Interne
city: Paris
country: France
facility: Hopital Lariboisiere
city: Perpignan
country: France
facility: CH de PERPIGNAN - Service Maladies infectieuses
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau
city: Tours
country: France
facility: CHRU de Tours - Service Médecine interne et immunologie Clinique
city: Tours
country: France
facility: CHRU de Tours - Service Pneumologie
city: Tours
country: France
facility: CHRU DE TOURS - Service Médecine interne et maladies infectieuses
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Monaco
country: Monaco
facility: centre Hospitalier Princesse Grace
Study officials:
affiliation: CHR Orléans
name: Mai-Anh NAY, Dr
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.