CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 446 enrolled
Drug / intervention
1: Prone positioning +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04366856
NCT04366856N/ACompleted

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

Assistance Publique - Hôpitaux de Paris·interventional·Posted Apr 29, 2020·Updated Dec 13, 2021

In Brief

A clinical study evaluating 1: Prone positioning and 2: No instruction regarding positioning for COVID and ARDS. Completed, enrolled 446 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID, ARDS
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 29, 2020
Enrollment StartJun 26, 2020
Primary CompletionSep 23, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.2 years ago

Interventions

1: Prone positioningbehavioral

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

2: No instruction regarding positioningbehavioral

group with no instruction regarding positioning (control group)