Influence of Lung Recruitment Potential on Positive End-Expiratory Pressure (PEEP) Titration Strategies in Acute Respiratory Distress Syndrome (ARDS) Patients. (RECRUIT-PEEP)
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)
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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:
- PEEP titration targeted to achieve the best static compliance of the respiratory system.
- 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.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Esteban Santis, RT.
- Telefonnummer: +56 940367716
- E-Mail: esteban.santis@ogb.cl
Studieren Sie die Kontaktsicherung
- Name: Hospital Dr. Franco Ravera Zunino
- Telefonnummer: +56 729383
- E-Mail: carolina.lindsay.brain@gmail.com
Studienorte
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Región del Libertador General Bernardo O’Higgins
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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile, 2820000
- Rekrutierung
- Dr. Franco Ravera Zunino Hospital
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Kontakt:
- Renatto Anfossi
- Telefonnummer: +569 722729383
- E-Mail: ranfossi.hrlbo@gmail.com
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Kontakt:
- Carolina Lindsay, PhD
- Telefonnummer: +56 72 2 729383
- E-Mail: c.lindsay.hfrz@gmail.com
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Hauptermittler:
- Esteban Santis
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: 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
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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:
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Experimental: 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.
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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:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Early Oxygenation (PaO2/FiO2 Ratio).
Zeitfenster: Baseline and 24 hours post-PEEP titration
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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.
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Baseline and 24 hours post-PEEP titration
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Ventilatory Efficiency
Zeitfenster: Baseline, 24, 48, and 72 hours
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Evaluated using the Ventilatory Ratio (VR), which correlates physiological dead space and minute ventilation.
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Baseline, 24, 48, and 72 hours
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Incidence of Elevated Airway Opening Pressure (AOP)
Zeitfenster: Pre-randomization (Baseline)
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Proportion of patients exhibiting an airway opening pressure greater than 5 cmH2O.
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Pre-randomization (Baseline)
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Ventilator-Free Days (VFD)
Zeitfenster: Up to Day 28
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Number of days alive and free from invasive mechanical ventilation within a 28-day window.
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Up to Day 28
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Evolution of Static Compliance of the Respiratory System
Zeitfenster: Baseline, 1, 24, 48, and 72 hours
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Changes in static compliance calculated via the formula: Tidal Volume / (Plateau Pressure - Positive End-Expiratory Pressure).
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Baseline, 1, 24, 48, and 72 hours
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Evolution of Driving Pressure and Plateau Pressure
Zeitfenster: Baseline, 1, 24, 48, and 72 hours
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Serial monitoring of driving pressure (Plateau Pressure - Positive End-Expiratory Pressure) and plateau pressure to evaluate lung stress.
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Baseline, 1, 24, 48, and 72 hours
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Incidence of Procedure-Related Adverse Events
Zeitfenster: Throughout mechanical ventilation (Up to 28 days)
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Proportion of participants experiencing complications due to recruitment maneuvers or Positive End-Expiratory Pressure (PEEP) titration (e.g., severe hypotension, barotrauma).
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Throughout mechanical ventilation (Up to 28 days)
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienstuhl: Francisco Cerda, RT., Hospital Dr. Franco Ravera Zunino
- Studienstuhl: Javier Astudillo, MD., Hospital Dr. Franco Ravera Zunino
- Studienstuhl: Jennifer Ayuso, RT., Hospital Dr. Franco Ravera Zunino
- Studienstuhl: Rodrigo Arevalo, RT., Hospital Dr. Franco Ravera Zunino
- Studienstuhl: Carlos Pellegrini, MD., Hospital Dr. Franco Ravera Zunino
- Hauptermittler: Esteban Santis, RT., Hospital Dr. Franco Ravera Zunino
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- HFRZ-UPC-2026-01
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Beschreibung des IPD-Plans
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