Personalized PEEP and Prone Positioning in Severe ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This master protocol investigates personalized strategies for mechanical ventilation in moderate-to-severe ARDS. It includes approaches to set PEEP based on individual recruitability and explores the role of prone positioning and neuromuscular blockade. The study uses a sequential randomization design to test minimal distension versus maximal recruitment strategies, combined with prone positioning and early or rescue neuromuscular blockade. Outcomes focus on whether patient-specific ventilation settings can improve oxygenation and survival while maintaining safety. The trial is conducted in French ICU centers under a centralized lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Invasive mechanical ventilation within 96 hours of ICU admission and within 72 hours of tracheal intubation for first randomization and then within 72 hours of the first randomization for the second randomization
* Patients meeting the Berlin ARDS definition criteria with hypoxemia characterized as

  * for first randomization: PaO2/FiO2 ≤150 mmHg on a PEEP ≥5 cmH2O with FiO2≥0.6 while VT is 6 ml/kg Predicted Body Weight (PBW) and adequate sedation level to adjust mechanical ventilation settings
  * for second randomization: PaO2/FiO2 ≤150 mmHg on optimized ventilatory settings according to the first randomization, confirmed by two Arterial blood gas (ABG) analyses separated by an interval time of 4 hours and observed within 72 hours of the first randomization
* Informed consent signed:

  * by the patient
  * Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6
  * Or in a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.
* Health insurance coverage

Exclusion Criteria:

* Age \< 18 years
* Known pregnancy or breastfeeding
* Participation in another interventional studies as long as these studies do not interfere with the primary endpoint and the secondary safety objectives of PEPER, or being in the exclusion period at the end of a previous study.
* Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mmHg
* Severe chronic respiratory disease requiring long-term O2 therapy or home mechanical ventilation (except Continuous positive arway pressure (CPAP)/ Bilevel positive airway pressure (BIPAP) used for sleep apnea syndrome)
* Chronic interstitial lung disease
* Continuous neuromuscular blockade infusion at enrolment
* Previous hypersensitivity or anaphylactic reaction to any NMBA
* Neuromuscular disease that may potentiate neuromuscular blockade or impair spontaneous ventilation: amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, upper spinal injury at level C5 or above
* Patients on ECMO or any technique of extracorporeal CO2 removal
* Sickle cell disease
* Actual body weight \>1 kg/cm of height
* Severe chronic liver disease defined as a Child-Pugh score of 12-15
* Pneumothorax at randomization
* Expected duration of mechanical ventilation \<48 hours
* Simplified acute physiology score SAPS II score \>75 at the time of enrolment or suffering from a disease with an estimated survival time of less than two months
* Decision to withhold life-sustaining treatment
* Patients deprived of freedom or under legal authority
* Unstable spine fracture

Where it's running

• CH Aix
  Aix-en-Provence, France Recruiting
• Hôpital Pellegrin
  Bordeaux, France Recruiting
• CH Fleyriat
  Bourg-en-Bresse, France Recruiting
• Cavale Blanche
  Brest, France Recruiting
• CHU de Caen Normandie
  Caen, France Recruiting
• Hôpital de Dieppe
  Dieppe, France Recruiting

Study contacts

• Study coordinator: Alexandre Demoule, MD PhD
• Email: alexandre.demoule@aphp.fr
• Phone: +33 1 42 16 38 31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding immune patterns and ECMO strategies to help adults with severe ARDS

  This study tests how different immune and clinical patterns in adults with moderate-to-severe ARDS respond to ECMO and lung-protective care, aiming to improve outcomes.

  Recruiting at 16 sites Southeast University, China · Beijing, Beijing Municipality and 38 other locations · NCT07726940

• Optimal corticosteroid dosing for ARDS: short vs. prolonged therapy

  This trial tests different corticosteroid doses and treatment lengths to see which helps adults with ARDS who are on ventilators.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT07711964

• Lateral positioning to optimize breathing in adults after abdominal surgery with ARDS

  This study tests whether lying on the left or right side helps improve lung function in adults who developed ARDS after abdominal surgery, using a bedside imaging test to watch ventilation and blood flow while changing positions.

  Recruiting Ruijin Hospital · Shanghai · NCT07669558

• Dexamethasone for sepsis-related ARDS in adults on ventilatory support

  This trial tests whether dexamethasone can help adults with sepsis-associated ARDS on ventilators recover better compared to placebo.

  Recruiting Phase 3 Southeast University, China · Nanjing, Jiangsu and 1 other locations · NCT07576660

• NIRS for EDResp: Which first helps hypoxemic adults best?

  This trial tests whether non-invasive ventilation with a mask (NIPPV) or high-flow nasal oxygen (HFNO) is more helpful for adults in the emergency department with acute hypoxemic respiratory failure.

  Recruiting at 9 sites Ohio State University · Tucson, Arizona and 8 other locations · NCT07558265

• Sodium bicarbonate with bedside electrical impedance tomography to map lung blood flow in ventilated adults

  This project will try whether a small sodium bicarbonate injection combined with bedside electrical impedance tomography can map lung blood flow in adults on mechanical ventilation, compared with hypertonic saline.

  Recruiting First Affiliated Hospital of Wannan Medical College · Wuhu, Anhui · NCT07542366

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.