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

NCT04363463 | Completed

• 1 other identifier: CHRO-2020-09
• Study Type: interventional
• Target: 268
• Locations: 2 countries
• Sites: 19

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.

Conditions

COVID19; Oxygen Therapy; Prone Position; Spontaneous Ventilation; Respiratory Distress Syndrome

Keywords

COVID19; Oxygen therapy; Prone position; Spontaneous ventilation; Acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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

  Day 28

Secondary Outcomes (8)

• Duration in days for the change of 2 points on the WHO ordinal scale

  Day 28

• Rate (%) of intubation and invasive ventilation in the 2 randomization groups.

  Day 28

• Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups

  Day 28

• Duration of oxygen therapy in the 2 randomization groups.

  Day 28

• Duration of hospitalization in the 2 randomization groups.

  Day 28

Study Arms (2)

Conventional positioning

NO INTERVENTION

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).

Interventional positioning : prone position

EXPERIMENTAL

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

Interventions

prone position 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.

Interventional positioning : prone position

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (19)

CH de Blois

Blois, 41016, France

Location

CH de DAX

Dax, 40100, France

Location

CHD de VENDEE

La Roche-sur-Yon, 85925, France

Location

CH de LA ROCHELLE

La Rochelle, 17019, France

Location

CH Le Mans

Le Mans, 72037, France

Location

CH Mont de MArsan

Mont-de-Marsan, 40012, France

Location

CHR d'Orléans - Service Pneumologie

Orléans, 45000, France

Location

CHR d'Orleans - Service Maladies Infectieuses

Orléans, 45067, France

Location

HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition

Paris, 75010, France

Location

Hopital Européen Georges Pompidou

Paris, France

Location

Hopital Lariboisiere - Medecine Interne

Paris, France

Location

Hopital Lariboisiere

Paris, France

Location

CH de PERPIGNAN - Service Maladies infectieuses

Perpignan, 66046, France

Location

Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau

Quimper, 29000, France

Location

CHRU de Tours - Service Médecine interne et immunologie Clinique

Tours, 37000, France

Location

CHRU de Tours - Service Pneumologie

Tours, 37000, France

Location

CHRU DE TOURS - Service Médecine interne et maladies infectieuses

Tours, 37044, France

Location

CH Bretagne Atlantique

Vannes, 56017, France

Location

centre Hospitalier Princesse Grace

Monaco, Monaco

Location

Related Publications (6)

• 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.

  PMID: 32159735 BACKGROUND

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

• 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.

  PMID: 32167524 BACKGROUND

• Nay MA, Hindre R, 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, Jamard S, Nyamankolly E, Planquette B, Fossat G, Boulain T. Prone position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomised controlled trial. Crit Care. 2023 Jun 17;27(1):240. doi: 10.1186/s13054-023-04529-z.

  PMID: 37330512 DERIVED

• 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.

  PMID: 35803621 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mai-Anh NAY, Dr

  CHR Orléans

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled multicenter trial Ratio 1:1

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 27, 2020
• Study Start: August 28, 2020
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

FR (18); MO (1)