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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 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

52

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studera Kontakt Backup

Studieorter

  • Chile
    • Región del Libertador General Bernardo O’Higgins
      • Rancagua, Región del Libertador General Bernardo O’Higgins, Chile, 2820000
        • Rekrytering
        • Dr. Franco Ravera Zunino Hospital
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Esteban Santis

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Procedur: 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.

Andra namn:
  • Initial Lung Recruitment Maneuver
Experimentell: 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.
Procedur: 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.

Andra namn:
  • Initial Lung Recruitment Maneuver

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Early Oxygenation (PaO2/FiO2 Ratio).
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ventilatory Efficiency
Tidsram: 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)
Tidsram: Pre-randomization (Baseline)
Proportion of patients exhibiting an airway opening pressure greater than 5 cmH2O.
Pre-randomization (Baseline)
Ventilator-Free Days (VFD)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Dr. Franco Ravera Zunino

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

30 juni 2027

Avslutad studie (Beräknad)

30 september 2027

Studieregistreringsdatum

Först inskickad

18 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HFRZ-UPC-2026-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

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