Not Yet RecruitingNot Applicable

Influence of Lung Recruitment Potential on PEEP Titration Strategies in ARDS Patients.

52 participantsStarted 2026-06-01

Plain-language summary

Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and diffuse alveolar collapse, often requiring invasive mechanical ventilation. Non-individualized mechanical ventilation settings can cause ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP) prevents alveolar collapse, but its effect varies among individuals. The recruitment-to-inflation (R/I) ratio evaluates bedside lung recruitment potential. This pilot study aims to compare two individualized PEEP titration strategies-one guided by the best static respiratory compliance and another guided by transpulmonary pressure via an esophageal balloon-and evaluate how baseline lung recruitment potential alters the early physiological responses to these interventions. Both strategies are preceded by an identical, standardized pressure-controlled initial lung recruitment maneuver to establish a baseline recruitment state.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: acute onset, bilateral opacities not fully explained by heart failure or fluid overload, and PaO2/FiO2 \<= 200 mmHg with PEEP \>= 5 cmH2O. * ARDS duration \< 36 hours since fully meeting Berlin consensus criteria. * Relative hemodynamic stability: absence of refractory shock, defined as norepinephrine dose \<= 0.5 mcg/kg/min. Exclusion Criteria: * Evidence of active pulmonary air leaks (bronchopleural fistula, pneumothorax, pneumomediastinum). * Severe uncorrected hemodynamic instability (norepinephrine \> 0.5 mcg/kg/min). * Contraindications for esophageal balloon placement (esophageal obstruction, known perforation, recent esophageal surgery, severe esophagitis). * Elevated intracranial pressure or conditions where hypercapnia-induced increases in intracranial pressure must be avoided (intracranial hemorrhage, cerebral contusion, cerebral edema, mass effect with midline shift on CT). * Known pregnancy. * Severe coagulopathy (platelet count \< 5,000/uL or INR \> 3). * Airway opening pressure higher than 15 cmH2O (AOP \> 15 cmH2O). * History of severe neuromuscular disease or chronic respiratory disease. * Having received invasive mechanical ventilation for more than 96 hours. * Inability to obtain informed consent or refusal by the legal representative. * Contained laparotomy (open abdomen).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial isn't recruiting yet — do you know when it's expected to open, and would it make sense for us to revisit this option once enrollment begins?
2The study is testing different PEEP titration strategies based on how recruitable a patient's lungs are — can you explain whether my lung recruitment potential would be assessed, and how that might influence which ventilator settings I'd receive?
3Since this trial is listed as Phase NA, which often applies to device or procedure studies rather than drug trials, what does that mean for how much is already known about the safety of these PEEP titration approaches in ARDS patients like me?
4The main thing being measured is the change in the PaO2/FiO2 ratio, which reflects how well oxygen is getting from the lungs into the blood — how would you track that in my case, and what would it tell us about whether the ventilator strategy is working?
5Are there standard PEEP titration protocols already in use for ARDS that my care team would follow outside of this trial, and how do those compare to what this study is investigating?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Early Oxygenation (PaO2/FiO2 Ratio).

Timeframe: Baseline and 24 hours post-PEEP titration

Trial details

NCT IDNCT07603310

SponsorHospital Dr. Franco Ravera Zunino

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Esteban Santis, RT.

940367716 esteban.santis@ogb.cl

View on ClinicalTrials.gov More ARDS (Acute Respiratory Distress Syndrome) trials