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New treatment option for Acute Respiratory Distress Syndrome
Official title Extended Prone Positioning for Intubated ARDS
ClinicalTrials.gov ID: NCT07126964
What this study is testing
- What it's testing
- Acute respiratory distress syndrome (ARDS) is an acutely induced respiratory failure characterised by the appearance of bilateral alveolar opacities on imaging and hypoxemia(1). Among strategies that have proved beneficial in terms of patient outcome, prone position (PP) is one associated with the greatest impact in terms of reduction in mortality, with PP sessions of 17h on average(2).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age of 18 years
- Admitted to ICU.
- Under invasive ventilation for a maximum of 5 days.
- Meeting the 2012 Berlin criteria for ARDS
- Protective ventilation at time of inclusion :
You likely can't join if
- PP during the same ICU stay and before inclusion, ECMO before PP, arterio-venous ECMO
- persistent PaO₂/FiO₂ ratios \<150 mm Hg, with FiO2 ≥ 60% on all arterial blood gases collected over a 24-hour period without this prompting study...
- Spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in...
- Home oxygen supplementation
- Care limited to comfort measures only
- Inclusion in another treatment study including mechanically ventilated patients, which intervention concerns PP and for which mortality à D28 or D30...
See the full eligibility criteria
- Age of 18 years
- Admitted to ICU.
- Under invasive ventilation for a maximum of 5 days.
- Meeting the 2012 Berlin criteria for ARDS
- Protective ventilation at time of inclusion :
- Plateau pressure \< 35 cm of H2O at the time of screening
- VT ≤ 8 ml/kg PBW on all nurse's charts before inclusion
- PEEP ≥ 5 cm H2O on all nurse's charts before inclusion c. Twice daily blood gas while FiO2 ≥ 60% before inclusion
- PaO2/FiO2 ≤ 150 mmHg with FiO2 ≥ 60% and Spo2 between 92 and 96% after optimization by setting PEEP to 10 mmHg, sedation levels optimization and, if necessary, administration of neuromuscular blockers to ensure...
- PP during the same ICU stay and before inclusion, ECMO before PP, arterio-venous ECMO
- persistent PaO₂/FiO₂ ratios \<150 mm Hg, with FiO2 ≥ 60% on all arterial blood gases collected over a 24-hour period without this prompting study inclusion
- Spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in charge
- Home oxygen supplementation
- Care limited to comfort measures only
- Inclusion in another treatment study including mechanically ventilated patients, which intervention concerns PP and for which mortality à D28 or D30 is the main outcome studied.
- Already included in PROSECO
- Pregnancy, subject deprived of freedom, Person under conservartorship, no insurance
- Refusal to participate expressed by the patient or his/her healthcare proxy or a close relative if present
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.