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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 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

52

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Chile
    • Región del Libertador General Bernardo O’Higgins
      • Rancagua, Región del Libertador General Bernardo O’Higgins, Chile, 2820000
        • Recrutamento
        • Dr. Franco Ravera Zunino Hospital
        • Contato:
        • Contato:
        • Investigador principal:
          • Esteban Santis

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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
Procedimento: 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.

Outros nomes:
  • Initial Lung Recruitment Maneuver
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.
Procedimento: 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.

Outros nomes:
  • Initial Lung Recruitment Maneuver

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Early Oxygenation (PaO2/FiO2 Ratio).
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Ventilatory Efficiency
Prazo: 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)
Prazo: Pre-randomization (Baseline)
Proportion of patients exhibiting an airway opening pressure greater than 5 cmH2O.
Pre-randomization (Baseline)
Ventilator-Free Days (VFD)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospital Dr. Franco Ravera Zunino

Investigadores

  • Cadeira de estudo: Francisco Cerda, RT., Hospital Dr. Franco Ravera Zunino
  • Cadeira de estudo: Javier Astudillo, MD., Hospital Dr. Franco Ravera Zunino
  • Cadeira de estudo: Jennifer Ayuso, RT., Hospital Dr. Franco Ravera Zunino
  • Cadeira de estudo: Rodrigo Arevalo, RT., Hospital Dr. Franco Ravera Zunino
  • Cadeira de estudo: Carlos Pellegrini, MD., Hospital Dr. Franco Ravera Zunino
  • Investigador principal: Esteban Santis, RT., Hospital Dr. Franco Ravera Zunino

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2026

Conclusão Primária (Estimado)

30 de junho de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HFRZ-UPC-2026-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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