PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)

NCT04366856 | Completed

• 1 other identifier: APHP200504
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%) The investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.

Conditions

COVID; ARDS

Keywords

ARDS; SARS-Cov-2 infection; Prone position; Oxygenotherapy; Intubation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who meet one or both following criteria: need for intubation (for mechanical ventilation), occurrence of death during hospital stay.

  At day28

Secondary Outcomes (5)

• Proportion of patients admitted to ICU (for patients included out of ICU)

  At day28

• Days alive and free from non invasive ventilation (NIV) or high flow nasal canula oxygen delivery (HFNC) (for those neither under NIV or HFNC at the time of study inclusion)

  At day28

• Days alive and out of ICU

  At day28

• Days alive and out of hospital

  At day28

• Maximum oxygenotherapy rate during hospital stay [Time Frame: At day28]

  At day28

Study Arms (2)

1: Prone positioning

EXPERIMENTAL

the interventional group will be suggested to spend at least 6 hours a day in prone position

Behavioral: 1: Prone positioning

2: No instruction regarding positioning

OTHER

the control group will get no instruction regarding positioning

Behavioral: 2: No instruction regarding positioning

Interventions

1: Prone positioning BEHAVIORAL

the interventional group will be suggested to spend at least 6 hours a day in prone position

1: Prone positioning

2: No instruction regarding positioning BEHAVIORAL

group with no instruction regarding positioning (control group)

2: No instruction regarding positioning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the hospital
• Laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities)
• Need for O2 3L/min to get an SpO2 higher or equal to 95%.
• Patient able to understand and to get in prone postion themself
• No therapeutic limitation

You may not qualify if:

• Age \> 80 years
• Pregnancy
• Impossibility to get in prone position

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Département d'Anesthésie Réanimation - Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Related Publications (1)

• Harrois A, Jouffroy R, Ayed S, Bruel C, Savale L, Devaux M, Maillet M, Cerf C, Lejealle C, Moreno CG, Levrat A, Gueneau R, Jouveshomme S, Bonnin P, De Rudnicki S, Damoisel C, Gille T, Cordel H, Meslin S, Bocquillon V, Noel N, Vieillard-Baron A, Teboul JL, Tran M, Werner M, Pichon J, Janbain A, Vicaut E, Duranteau J; PROVID Study Group. Awake Prone Positioning in Patients With COVID-19 Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548201. doi: 10.1001/jamanetworkopen.2025.48201.

  PMID: 41370078 DERIVED

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Anatole HARROIS

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: June 26, 2020
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

FR (1)