Individualized PEEP Titration in ARDS Based on Lung Recruitment Potential

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 is a prospective, randomized pilot study enrolling adults with moderate-to-severe ARDS within 36 hours of Berlin criteria. After a standardized recruitment maneuver, participants are assigned to either PEEP titration based on the best static respiratory system compliance or based on transpulmonary pressure measured with an esophageal balloon. The trial uses the recruitment-to-inflation ratio to categorize baseline lung recruitment potential and investigates how this baseline status influences early physiological responses to the two strategies. It is conducted at Hospital Dr. Franco Ravera Zunino in Rancagua, Chile, with an open-label design and parallel-group format.

Why it matters

Who can join: the full rules

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 Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen \<= 200 mmHg with Positive End-Expiratory Pressure (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).

Where it's running

• Dr. Franco Ravera Zunino Hospital
  Rancagua, Región del Libertador General Bernardo O’Higgins, Chile Recruiting

Study contacts

• Principal investigator: Esteban Santis, RT. — Hospital Dr. Franco Ravera Zunino
• Study coordinator: Esteban Santis, RT.
• Email: esteban.santis@ogb.cl
• Phone: 940367716

Similar studies

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

• Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS

  This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07908368

• Biorepository and endotyping study for ARDS patients

  This observational study tests whether creating a centralized ARDS biorepository and data set can help develop endotype and treatment-prediction tools for adults with ARDS.

  Recruiting Prenosis, Inc. · Urbana, Illinois · NCT07675265

• BAL balance: ARDS through lung lavage and imaging to find different ARDS types

  This study tests how bronchoalveolar lavage fluid and chest CT imaging can reveal different ARDS subtypes in adults with ARDS or severe pneumonia in the ICU.

  Recruiting Medical University of Vienna · Vienna, State of Vienna · NCT07633366

• Titrating PEEP in ARDS: Manual chest compression vs. electrical impedance tomography

  In adults with ARDS on mechanical ventilation, the study tests whether a simple manual chest compression method can set the right PEEP as well as electrical impedance tomography (EIT).

  Recruiting at 2 sites Centre Hospitalier Saint Joseph Saint Luc de Lyon · Créteil and 1 other locations · NCT07623590

• Single-dose inhaled rh-KGF-2 for ARDS in adults

  This trial tests whether a single inhaled dose of rh-KGF-2 helps adults with ARDS who are on ventilators, using three dose levels to see which is safest and potentially most effective.

  Recruiting Early Phase 1 Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07558538

• HT31-1 for ARDS: a first-in-human test of a monoclonal antibody

  This early study tests whether HT31-1, a monoclonal antibody, is safe and how it behaves in the body in healthy adults, with a plan to move into ARDS patients later.

  Recruiting Phase 1 HTIC, Inc · Richmond, Virginia and 1 other locations · NCT07449572

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.