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

7 juillet 2026 mis à jour par: Hospital Dr. Franco Ravera Zunino

Influence of the Lung Recruitment Potential on the Response to Two Positive End-Expiratory Pressure (PEEP) Titration Strategies in Patients With Acute Respiratory Distress Syndrome (ARDS)

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a prospective, randomized, open-label, parallel-group pilot study conducted at the Adult Intensive Care Unit of Hospital Dr. Franco Ravera Zunino (HFRZ). Eligible adult patients under invasive mechanical ventilation with moderate-to-severe ARDS within 36 hours of fulfilling Berlin criteria will be evaluated.

Prior to randomization, the patient's recruitment potential will be measured bedside using the R/I ratio (where > 0.5 indicates high recruitment potential and <= 0.5 indicates low potential). Eligible participants will then be randomized 1:1 into two PEEP titration groups:

  1. PEEP titration targeted to achieve the best static compliance of the respiratory system.
  2. PEEP titration guided by transpulmonary pressure measured via an esophageal balloon to target a positive end-expiratory transpulmonary pressure.

Crucially, immediately before starting the specific PEEP titration protocol in either group, an identical, standardized lung recruitment maneuver will be performed. This maneuver is executed in pressure-controlled ventilation (PCV) with a control pressure of 15 cmH2O, I:E ratio of 1:1, FiO2 1.0, starting with PEEP 5 cmH2O and increasing by 5 cmH2O every 10 seconds up to PEEP 25 cmH2O, maintaining a maximum peak pressure limit of 40 cmH2O for exactly 1 minute.

Standard baseline ventilator parameters will follow protective ventilation targets: volume-controlled ventilation, tidal volume 6-8 mL/kg of predicted body weight, respiratory rate adjusted to keep pH 7.25-7.45, plateau pressure < 28 cmH2O, and driving pressure < 14 cmH2O. Physiological parameters (PaO2/FiO2, driving pressure, ventilatory ratio, static compliance) will be recorded at 1, 24, 48, and 72 hours. The primary outcome is the change in oxygenation (PaO2/FiO2 ratio) at 24 hours. The study will explore how the baseline phenotype of lung recruitability alters early mechanical and gas exchange outcomes.

Type d'étude

Interventionnel

Inscription (Estimé)

52

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chili
    • Región del Libertador General Bernardo O’Higgins
      • Rancagua, Región del Libertador General Bernardo O’Higgins, Chili, 2820000
        • Recrutement
        • Dr. Franco Ravera Zunino Hospital
        • Contact:
        • Contact:
        • Chercheur principal:
          • Esteban Santis

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Best Static Compliance Titration
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
Procédure: Positive End-Expiratory Pressure (PEEP) Titration guided by Static Compliance

Positive End-Expiratory Pressure (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.

Autres noms:
  • Initial Lung Recruitment Maneuver
Expérimental: Transpulmonary Pressure Titration
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.
Procédure: Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary Pressure

Positive End-Expiratory Pressure (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.

Autres noms:
  • Initial Lung Recruitment Maneuver

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Early Oxygenation (PaO2/FiO2 Ratio).
Délai: Baseline and 24 hours post-PEEP titration
The change in gas exchange efficiency is calculated as the absolute difference between the baseline Partial pressure of oxygen in arterial blood (PaO2)/Fraction of inspired oxygen (FiO2) ratio and the PaO2/FiO2 ratio measured 24 hours after individualized Positive End-Expiratory Pressure (PEEP) titration.
Baseline and 24 hours post-PEEP titration

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Ventilatory Efficiency
Délai: Baseline, 24, 48, and 72 hours
Evaluated using the Ventilatory Ratio (VR), which correlates physiological dead space and minute ventilation.
Baseline, 24, 48, and 72 hours
Incidence of Elevated Airway Opening Pressure (AOP)
Délai: Pre-randomization (Baseline)
Proportion of patients exhibiting an airway opening pressure greater than 5 cmH2O.
Pre-randomization (Baseline)
Ventilator-Free Days (VFD)
Délai: Up to Day 28
Number of days alive and free from invasive mechanical ventilation within a 28-day window.
Up to Day 28
Evolution of Static Compliance of the Respiratory System
Délai: Baseline, 1, 24, 48, and 72 hours
Changes in static compliance calculated via the formula: Tidal Volume / (Plateau Pressure - Positive End-Expiratory Pressure).
Baseline, 1, 24, 48, and 72 hours
Evolution of Driving Pressure and Plateau Pressure
Délai: Baseline, 1, 24, 48, and 72 hours
Serial monitoring of driving pressure (Plateau Pressure - Positive End-Expiratory Pressure) and plateau pressure to evaluate lung stress.
Baseline, 1, 24, 48, and 72 hours
Incidence of Procedure-Related Adverse Events
Délai: Throughout mechanical ventilation (Up to 28 days)
Proportion of participants experiencing complications due to recruitment maneuvers or Positive End-Expiratory Pressure (PEEP) titration (e.g., severe hypotension, barotrauma).
Throughout mechanical ventilation (Up to 28 days)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Dr. Franco Ravera Zunino

Les enquêteurs

  • Chaise d'étude: Francisco Cerda, RT., Hospital Dr. Franco Ravera Zunino
  • Chaise d'étude: Javier Astudillo, MD., Hospital Dr. Franco Ravera Zunino
  • Chaise d'étude: Jennifer Ayuso, RT., Hospital Dr. Franco Ravera Zunino
  • Chaise d'étude: Rodrigo Arevalo, RT., Hospital Dr. Franco Ravera Zunino
  • Chaise d'étude: Carlos Pellegrini, MD., Hospital Dr. Franco Ravera Zunino
  • Chercheur principal: Esteban Santis, RT., Hospital Dr. Franco Ravera Zunino

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HFRZ-UPC-2026-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data (IPD) generated during this clinical trial will not be shared with other researchers due to ethical, legal, and privacy considerations. The study involves the collection of sensitive personal and health-related information. Furthermore, the informed consent process did not include provisions for unrestricted sharing of individual-level data with third parties. To ensure compliance with applicable data protection regulations and to safeguard participant confidentiality, only aggregated and anonymized study results will be made available through scientific publications, presentations, or upon reasonable request. These grouped data will provide sufficient information to support scientific transparency, interpretation of findings, and secondary analyses without compromising the privacy of participants

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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