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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04363463
Other study ID # CHRO-2020-09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2020
Est. completion date January 13, 2022

Study information

Verified date December 2022
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date January 13, 2022
Est. primary completion date January 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CH de Blois Blois
France CH de DAX Dax
France CHD de VENDEE La Roche sur Yon
France CH de LA ROCHELLE La Rochelle
France CH Le Mans Le Mans
France CH Mont de MArsan Mont-de-Marsan
France CHR d'Orleans - Service Maladies Infectieuses Orléans
France CHR d'Orléans - Service Pneumologie Orléans
France Hopital Européen Georges Pompidou Paris
France Hopital Lariboisiere Paris
France Hopital Lariboisiere - Medecine Interne Paris
France HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition Paris
France CH de PERPIGNAN - Service Maladies infectieuses Perpignan
France Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau Quimper
France CHRU de Tours - Service Médecine interne et immunologie Clinique Tours
France CHRU DE TOURS - Service Médecine interne et maladies infectieuses Tours
France CHRU de Tours - Service Pneumologie Tours
France CH Bretagne Atlantique Vannes
Monaco centre Hospitalier Princesse Grace Monaco

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Countries where clinical trial is conducted

France,  Monaco, 

References & Publications (4)

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;: — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) Day 28
Secondary 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 Day 28
Secondary 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 Day 28
Secondary Duration of oxygen therapy in the 2 randomization groups. Show that prone position in spontaneous ventilation reduces the time under oxygen therapy. Day 28
Secondary Duration of hospitalization in the 2 randomization groups. Show that prone position reduces the length of hospitalization. Day 28
Secondary Hospital mortality and mortality at D28 in the 2 randomization groups Compare the hospital mortality of the 2 groups Day 28
Secondary Rate (%) of need for transfer to intensive care unit Compare the incidence of the need for resuscitation transfer between the two groups. Day 28
Secondary 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. 1 year
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