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

COVID19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363463
• Other study ID #: CHRO-2020-09
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• COVID19
• Oxygen Therapy
• Prone Position
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Spontaneous Ventilation

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