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)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Esteban Santis, RT.
- 電話番号：+56 940367716
- メール：esteban.santis@ogb.cl
研究連絡先のバックアップ
- 名前：Hospital Dr. Franco Ravera Zunino
- 電話番号：+56 729383
- メール：carolina.lindsay.brain@gmail.com
研究場所
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Región del Libertador General Bernardo O’Higgins
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Rancagua、Región del Libertador General Bernardo O’Higgins、チリ、2820000
- 募集
- Dr. Franco Ravera Zunino Hospital
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コンタクト：
- Renatto Anfossi
- 電話番号：+569 722729383
- メール：ranfossi.hrlbo@gmail.com
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コンタクト：
- Carolina Lindsay, PhD
- 電話番号：+56 72 2 729383
- メール：c.lindsay.hfrz@gmail.com
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主任研究者：
- Esteban Santis
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Early Oxygenation (PaO2/FiO2 Ratio).
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ventilatory Efficiency
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Francisco Cerda, RT.、Hospital Dr. Franco Ravera Zunino
- スタディチェア：Javier Astudillo, MD.、Hospital Dr. Franco Ravera Zunino
- スタディチェア：Jennifer Ayuso, RT.、Hospital Dr. Franco Ravera Zunino
- スタディチェア：Rodrigo Arevalo, RT.、Hospital Dr. Franco Ravera Zunino
- スタディチェア：Carlos Pellegrini, MD.、Hospital Dr. Franco Ravera Zunino
- 主任研究者：Esteban Santis, RT.、Hospital Dr. Franco Ravera Zunino
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HFRZ-UPC-2026-01
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