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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2022-12-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Régional d'Orléans

    lead OTHER

Principal Investigators

  • Mai-Anh NAY, Dr · CHR Orléans

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2022-01-13
Completion
2022-01-13

Countries

  • France
  • Monaco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363463 on ClinicalTrials.gov