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

NCT07603310 | Not Yet Recruiting DMC

• 1 other identifier: HFRZ-UPC-2026-01
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

Acute Respiratory Distress Syndrome; Positive End-Expiratory Pressure; Respiratory Mechanics; Lung Volume Measurements; Esophageal Monitoring; Ventilator-Induced Lung Injury; Artificial Respiration

Outcome Measures

Primary Outcomes (1)

• Change in Early Oxygenation (PaO2/FiO2 Ratio).

  The change in gas exchange efficiency is calculated as the absolute difference between the baseline PaO2/FiO2 ratio and the PaO2/FiO2 ratio measured 24 hours after individualized PEEP titration.

  Baseline and 24 hours post-PEEP titration

Secondary Outcomes (6)

• Evolution of Static Compliance of the Respiratory System

  Baseline, 1, 24, 48, and 72 hours

• Evolution of Driving Pressure and Plateau Pressure

  Baseline, 1, 24, 48, and 72 hours

• Ventilatory Efficiency

  Baseline, 24, 48, and 72 hours

• Incidence of Elevated Airway Opening Pressure (AOP)

  Pre-randomization (Baseline)

• Ventilator-Free Days (VFD)

  Up to Day 28

Study Arms (2)

Best Static Compliance Titration

EXPERIMENTAL

Patients receive positive end-expiratory pressure (PEEP) titration guided by the best static compliance of the respiratory system after undergoing a standardized initial lung recruitment maneuver

Procedure: PEEP Titration guided by Static Compliance

Transpulmonary Pressure Titration

EXPERIMENTAL

Patients receive positive end-expiratory pressure (PEEP) titration guided by transpulmonary pressure estimation via an esophageal balloon catheter after undergoing an identical standardized initial lung recruitment maneuver.

Procedure: PEEP Titration guided by Transpulmonary Pressure

Interventions

PEEP Titration guided by Static Compliance PROCEDURE

PEEP Titration by Static Compliance: Following the initial recruitment maneuver, an individualized PEEP decremental titration step-protocol is performed to identify the specific PEEP level that maximizes the static compliance of the respiratory system, aiming to optimize the balance between alveolar recruitment and overdistension. Initial Lung Recruitment Maneuver : Prior to individualized PEEP titration, all participants in this arm will undergo an initial standardized lung recruitment maneuver. This procedure will be executed in Pressure-Controlled Ventilation (PCV) mode, utilizing a driving/control pressure of 15 cmH2O. The recruitment process will begin at a baseline Positive End-Expiratory Pressure (PEEP) of 5 cmH2O, followed by incremental steps of 5 cmH2O every 10 seconds until reaching a maximum PEEP of 25 cmH2O. A peak airway pressure limit of 40 cmH2O will be strictly maintained during the maneuver for a total duration of 1 minute.

Also known as: Initial Lung Recruitment Maneuver

Best Static Compliance Titration

PEEP Titration guided by Transpulmonary Pressure PROCEDURE

PEEP Titration by Transpulmonary Pressure: Following the initial recruitment maneuver, PEEP is titrated and protocolized via real-time esophageal balloon monitoring to target and maintain a slightly positive expiratory transpulmonary pressure, minimizing cyclic alveolar collapse and overdistension. Initial Lung Recruitment Maneuver: Prior to individualized PEEP titration, all participants in this arm will undergo an initial standardized lung recruitment maneuver. This procedure will be executed in Pressure-Controlled Ventilation (PCV) mode, utilizing a driving/control pressure of 15 cmH2O. The recruitment process will begin at a baseline Positive End-Expiratory Pressure (PEEP) of 5 cmH2O, followed by incremental steps of 5 cmH2O every 10 seconds until reaching a maximum PEEP of 25 cmH2O. A peak airway pressure limit of 40 cmH2O will be strictly maintained during the maneuver for a total duration of 1 minute.

Also known as: Initial Lung Recruitment Maneuver

Transpulmonary Pressure Titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

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).

Sponsors & Collaborators

• Hospital Dr. Franco Ravera Zunino: lead

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Francisco Cerda, RT.

  Hospital Dr. Franco Ravera Zunino

  STUDY CHAIR

• Javier Astudillo, MD.

  Hospital Dr. Franco Ravera Zunino

  STUDY CHAIR

• Jennifer Ayuso, RT.

  Hospital Dr. Franco Ravera Zunino

  STUDY CHAIR

• Rodrigo Arevalo, RT.

  Hospital Dr. Franco Ravera Zunino

  STUDY CHAIR

• Carlos Pellegrini, MD.

  Hospital Dr. Franco Ravera Zunino

  STUDY CHAIR

• Esteban Santis, RT.

  Hospital Dr. Franco Ravera Zunino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esteban Santis, RT.

CONTACT

940367716; esteban.santis@ogb.cl

Hospital Dr. Franco Ravera Zunino

CONTACT

729383; carolina.lindsay.brain@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, parallel-group, open-label, exploratory clinical trial. Patients are stratified or analyzed according to their baseline lung recruitment potential (high vs. low, determined by the Recruitment/Inflation \[R/I\] ratio) and randomized to receive one of two early individualized PEEP titration strategies. Both arms undergo an identical initial lung recruitment maneuver prior to titration

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05