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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: eralp cevikkalp
- Numéro de téléphone: 905054554875
- E-mail: eralpcevikkalp@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: İrem Aydoğmuş
- E-mail: driremaydogmus@hotmail.com
Lieux d'étude
-
-
nilüfer
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Bursa, nilüfer, Turquie (Türkiye), 16000
- Bursa City Hospital
-
Contact:
- eralp cevikkalp
- Numéro de téléphone: 905054554875
- E-mail: eralpcevikkalp@hotmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Mechanical Power Group
Driving pressure-guided individualized PEEP group
|
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. |
|
Autre: Lung Protective Ventilation
Conventional lung-protective ventilation group
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
postoperative pulmonary complications
Délai: postoperative day 1,3,7
|
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.
|
postoperative day 1,3,7
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Inflammatory markers
Délai: Postoperative 1., 24, 48,72 hour and day 7
|
Postoperative biochemical markers, including CRP, neutrophil count, lymphocyte count, procalcitonin, white blood cell count, IL-6, and TNF-α, will be evaluated.
|
Postoperative 1., 24, 48,72 hour and day 7
|
|
İCU lenght of stay
Délai: From postoperative ICU admission to ICU discharge, assessed up to 30 days
|
Duration of İCU lenght of stay
|
From postoperative ICU admission to ICU discharge, assessed up to 30 days
|
|
Duration of mechanical ventilation
Délai: Time from intubation to successfull extubation
|
Duration of mechanical ventilation
|
Time from intubation to successfull extubation
|
|
30 day mortality
Délai: postoperative 30 day mortality
|
30 day mortality
|
postoperative 30 day mortality
|
|
Hospital lenght of stay
Délai: From hospital admission to hospital discharge, assessed up to 30 days
|
Hospital lenght of stay
|
From hospital admission to hospital discharge, assessed up to 30 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: eralp cevikkalp, Burs City Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 25.03.2026 2026-6/7
- 26-AKD-57 (Autre identifiant: Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency)
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