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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 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

52

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Procedure: 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.

Andere namen:
  • Initial Lung Recruitment Maneuver
Experimenteel: 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.
Procedure: 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.

Andere namen:
  • Initial Lung Recruitment Maneuver

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Early Oxygenation (PaO2/FiO2 Ratio).
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ventilatory Efficiency
Tijdsspanne: 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)
Tijdsspanne: Pre-randomization (Baseline)
Proportion of patients exhibiting an airway opening pressure greater than 5 cmH2O.
Pre-randomization (Baseline)
Ventilator-Free Days (VFD)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Dr. Franco Ravera Zunino

Onderzoekers

  • Studie stoel: Francisco Cerda, RT., Hospital Dr. Franco Ravera Zunino
  • Studie stoel: Javier Astudillo, MD., Hospital Dr. Franco Ravera Zunino
  • Studie stoel: Jennifer Ayuso, RT., Hospital Dr. Franco Ravera Zunino
  • Studie stoel: Rodrigo Arevalo, RT., Hospital Dr. Franco Ravera Zunino
  • Studie stoel: Carlos Pellegrini, MD., Hospital Dr. Franco Ravera Zunino
  • Hoofdonderzoeker: Esteban Santis, RT., Hospital Dr. Franco Ravera Zunino

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

18 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HFRZ-UPC-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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