Individualized PEEP and Pulmonary Complications in On-Pump CABG
Effect of Individualized PEEP Guided by Driving Pressure and Mechanical Power on Postoperative Pulmonary Complications in On-Pump CABG: A Randomized Controlled Trial
Postoperative pulmonary complications (PPCs) are an important cause of morbidity and mortality after major surgery and are frequently observed in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These complications are associated with prolonged mechanical ventilation, longer intensive care unit and hospital stays, increased healthcare costs, and higher mortality (1,2).
Intraoperative lung-protective ventilation strategies have traditionally focused on individual parameters such as low tidal volume, positive end-expiratory pressure (PEEP), plateau pressure, and driving pressure. However, the effects of these parameters on postoperative pulmonary outcomes in cardiac surgery patients remain unclear. In particular, PEEP- and driving pressure-guided approaches are controversial in terms of feasibility and safety in patients undergoing CPB, who may be hemodynamically vulnerable.
Mechanical power is a comprehensive parameter that reflects the total energy delivered to the respiratory system per unit of time by integrating ventilatory variables such as tidal volume, airway pressures, respiratory rate, and flow. Therefore, mechanical power may provide a more comprehensive assessment of the mechanical load applied to the lungs compared with individual ventilatory parameters. Previous studies have reported that higher mechanical power values may be associated with lung injury, postoperative pulmonary complications, and mortality (3).
The aim of this study is to evaluate the effect of monitoring mechanical power during perioperative mechanical ventilation on postoperative pulmonary complications in patients undergoing cardiac surgery with cardiopulmonary bypass. The study hypothesis is that a mechanical power-based ventilation approach may reduce the incidence of PPCs compared with strategies based on conventional ventilation parameters.
Przegląd badań
Status
Szczegółowy opis
Postoperative pulmonary complications (PPCs) are an important cause of morbidity and mortality after major surgery and are frequently observed in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These complications are associated with prolonged mechanical ventilation, longer intensive care unit and hospital stays, increased healthcare costs, and higher mortality (1,2).
Intraoperative lung-protective ventilation strategies have traditionally focused on individual parameters such as low tidal volume, positive end-expiratory pressure (PEEP), plateau pressure, and driving pressure. However, the effects of these parameters on postoperative pulmonary outcomes in cardiac surgery patients remain unclear. In particular, PEEP- and driving pressure-guided approaches are controversial in terms of feasibility and safety in patients undergoing CPB, who may be hemodynamically vulnerable.
Mechanical power is a comprehensive parameter that reflects the total energy delivered to the respiratory system per unit of time by integrating ventilatory variables such as tidal volume, airway pressures, respiratory rate, and flow. Therefore, mechanical power may provide a more comprehensive assessment of the mechanical load applied to the lungs compared with individual ventilatory parameters. Previous studies have reported that higher mechanical power values may be associated with lung injury, postoperative pulmonary complications, and mortality (3).
The aim of this study is to evaluate the effect of monitoring mechanical power during perioperative mechanical ventilation on postoperative pulmonary complications in patients undergoing cardiac surgery with cardiopulmonary bypass. The study hypothesis is that a mechanical power-based ventilation approach may reduce the incidence of PPCs compared with strategies based on conventional ventilation parameters.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: eralp cevikkalp
- Numer telefonu: 905054554875
- E-mail: eralpcevikkalp@hotmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: İrem Aydoğmuş
- E-mail: driremaydogmus@hotmail.com
Lokalizacje studiów
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nilüfer
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Bursa, nilüfer, Turcja (Türkiye), 16000
- Bursa City Hospital
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Kontakt:
- eralp cevikkalp
- Numer telefonu: 905054554875
- E-mail: eralpcevikkalp@hotmail.com
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Patients with ASA physical status II-III who are scheduled to undergo elective open-heart surgery via on-pump median sternotomy will be included in the study.
Patients scheduled for emergency surgery, those planned to undergo off-pump cardiac surgery, patients with a history of myocardial infarction within the last 3 months, patients with advanced COPD, patients with an ARISCAT score of 44 or higher, patients with a BMI of 35 kg/m² or higher, patients with NYHA class IV status, patients receiving preoperative immunotherapy, and patients with severe hepatic or renal failure will be excluded from the study.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Mechanical Power Group
Driving pressure-guided individualized PEEP group
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After hemodynamic stability is achieved, the ventilator will be switched to volume-controlled mode with 6 ml/kg tidal volume , and a recruitment maneuver will be performed by gradually increasing PEEP to 20 cmH₂O. Subsequently, during the decremental PEEP trial, PEEP will be reduced by 2 cmH₂O every 20 seconds down to 6 cmH₂O, and ΔP (Pplat-PEEP) will be calculated at each step. The PEEP level associated with the lowest ΔP on the ΔP-PEEP curve will be identified, a second recruitment maneuver will be performed, and PEEP will then be fixed at this level. Before sternotomy, the minimum PEEP value that provides the lowest driving pressure will be determined, and this value will be maintained throughout the perioperative period, except during cardiopulmonary bypass. |
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Inny: Lung Protective Ventilation
Conventional lung-protective ventilation group
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In volume-controlled mechanical ventilation, tidal volume will be set at 6 mL/kg and PEEP will be fixed at 5 cmH₂O.
Ventilation will be maintained with these settings throughout the perioperative period, except during cardiopulmonary bypass.
Mechanical power values will also be calculated and recorded during all these periods.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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postoperative pulmonary complications
Ramy czasowe: postoperative day 1,3,7
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Postoperative pulmonary complications, including atelectasis, pneumonia, respiratory failure, pleural effusion, pneumothorax, and bronchospasm, will be assessed according to the EPCO(European Perioperative Clinical Outcome) criteria.
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postoperative day 1,3,7
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Inflammatory markers
Ramy czasowe: Postoperative 1., 24, 48,72 hour and day 7
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Postoperative biochemical markers, including CRP, neutrophil count, lymphocyte count, procalcitonin, white blood cell count, IL-6, and TNF-α, will be evaluated.
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Postoperative 1., 24, 48,72 hour and day 7
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İCU lenght of stay
Ramy czasowe: From postoperative ICU admission to ICU discharge, assessed up to 30 days
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Duration of İCU lenght of stay
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From postoperative ICU admission to ICU discharge, assessed up to 30 days
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Duration of mechanical ventilation
Ramy czasowe: Time from intubation to successfull extubation
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Duration of mechanical ventilation
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Time from intubation to successfull extubation
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30 day mortality
Ramy czasowe: postoperative 30 day mortality
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30 day mortality
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postoperative 30 day mortality
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Hospital lenght of stay
Ramy czasowe: From hospital admission to hospital discharge, assessed up to 30 days
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Hospital lenght of stay
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From hospital admission to hospital discharge, assessed up to 30 days
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: eralp cevikkalp, Burs City Hospital
Publikacje i pomocne linki
Publikacje ogólne
- 1. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data Neto, Ary Serpa et al. The Lancet Respiratory Medicine, Volume 4, Issue 4, 272 - 280 2. Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. 3. Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. PMID: 27620287. 4. Li XF, Jiang RJ, Mao WJ, Yu H, Xin J, Yu H. The effect of driving pressure-guided versus conventional mechanical ventilation strategy on pulmonary complications following on-pump cardiac surgery: A randomized clinical trial. J Clin Anesth. 2023 Oct;89:111150. doi: 10.1016/j.jclinane.2023.111150. Epub 2023 Jun 10. PMID: 37307653.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 25.03.2026 2026-6/7
- 26-AKD-57 (Inny identyfikator: Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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