Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Face-Down position may cut deaths in severe ARDS

NCT ID NCT00527813

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether placing patients with severe acute respiratory distress syndrome (ARDS) face down (prone) for at least 16 hours a day could lower their risk of dying. 474 adults on ventilators were randomly assigned to prone or standard (semi-recumbent) positioning. The main goal was to see if prone positioning reduced deaths within 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prone positioning (lying face down for at least 16 hours per day)
What this could lead to
If it works, this could become a standard, low-cost way to lower death rates in severe ARDS patients in intensive care.
What could go wrong
This is a completed trial, but results may not apply to all ARDS patients or settings. The benefit may be modest and depends on careful patient selection and care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

474 people

The number who actually took part.

Start date

Jan 2008

Finished

Nov 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients aged 18 years or more, both gender 2. Receiving endotracheal intubation and mechanical ventilation for less than 36 hours 3. Presenting with a Severe ARDS : * Acute onset * PaO2/FiO2 ≤ 200 (≤ 26.7 kPa) * Bilateral pulmonary infiltrates on frontal chest radiography * Capillary wedge pressure \< 18 mm Hg if measured or no evidence for left atrial hypertension 4. During since 12-24 hours 5. AND with severity criteria : PaO2/FiO2 \< 150 mm Hg (\< 20 kPa) under FiO2 ≥ 0.6, PEEP ≥ 5 cm H2O and a tidal volume equal to 6 ml/kg PBW. 6. Written consent from patient's next of kin Exclusion Criteria: 1. contra-indication to the prone position * Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mm Hg * Massive haemoptysis needing urgent surgical or radiological treatment * Tracheal or thoracic surgery in the last 15 days * Facial trauma or surgery in the last 15 days * Deep venous thrombosis or pulmonary embolism treated in the last 2 days * Cardiac pace maker implantation in the last 2 days * Unstable bone dislocations of rachis, femur, rib cage, pelvis * Mean systolic arterial pressure less than 70 mm Hg despite vasopressive therapy * Pregnancy * Bronchopleural fistula treated with a single anterior chest tube (risk of kinking in prone position) 2. Exclusion criteria for respiratory raisons * Necessity to use NOi or almitrine * Extra body circulation for oxygenation and/or CO2 epuration 3. Exclusion criteria linked to clinical context * Pulmonary transplantation * Burns ≥ 20% of body surface * Chronic respiratory insufficiency under home oxygen therapy or non invasive ventilation * Chronic disease supposed to be fatal in less than 1 year * Non invasive ventilation for more than 24 hours before enrollment 4. Other exclusion criteria * Decision to stop life-supportive therapies before enrollment * Enrollment in an other trial testing an intervention and with mortality as primary end point in the last 30 days * Prior enrollment in the same study * Prone position before enrollment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute respiratory distress syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hôpital Croix Rousse

    Lyon, 69317, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.