Face-Down position may cut deaths in severe ARDS
NCT ID NCT00527813
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
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474 people
The number who actually took part.
- Start date
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Jan 2008
- Finished
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Nov 2011
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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
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