Influence of Lung Recruitment Potential on Positive End-Expiratory Pressure (PEEP) Titration Strategies in Acute Respiratory Distress Syndrome (ARDS) Patients.

Recruiting now · Not applicable

Conditions studied: ARDS (Acute Respiratory Distress Syndrome)

In brief

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.

Key facts

Study ID

NCT07603310

Run by

Hospital Dr. Franco Ravera Zunino

People needed

52

Starts

2026-06-01

Expected to finish

2027-09-30

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Dr. Franco Ravera Zunino Hospital — Rancagua, Región del Libertador General Bernardo O’Higgins, Chile (enrolling)

Full record on ClinicalTrials.gov

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