Individualized PEEP and Pulmonary Complications in On-Pump CABG
NCT07623109 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-06-03
Summary
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.
Conditions
- Cardiac Surgery
- Mechanical Power
- Postoperative Pulmonary Complications (PPCs)
Interventions
- OTHER
-
Driving pressure-based personalized PEEP strategy
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.
- OTHER
-
Conventional lung protective mechanical ventilation strategy
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.
Sponsors & Collaborators
-
Bursa City Hospital
lead OTHER_GOV
Principal Investigators
-
eralp cevikkalp · Burs City Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-15
- Primary Completion
- 2026-06-15
- Completion
- 2026-07-15
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery
NCT07612709 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Individualized PEEP Titration on Postoperative Pulmonary Complications
NCT06150079 ·Status: COMPLETED ·Phase: NA
-
Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery
NCT05781373 ·Status: UNKNOWN ·Phase: NA
-
Mechanical Power and Driving Pressure Exposure in Laparoscopic Surgery
NCT07431242 ·Status: NOT_YET_RECRUITING
-
Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity
NCT06181279 ·Status: RECRUITING ·Phase: NA
-
Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass
NCT07432477 ·Status: RECRUITING ·Phase: NA
-
Comparison of Mechanical Power Calculations of Volume Control and Pressure Control Modes
NCT05494554 ·Status: COMPLETED
-
Ventilation During Cardiopulmonary Bypass
NCT04962542 ·Status: COMPLETED ·Phase: NA
-
Mechanical Power in One-lung Ventilation
NCT07353788 ·Status: NOT_YET_RECRUITING
-
Protective Ventilatory Strategy in Potential Organ Donors
NCT00260676 ·Status: UNKNOWN ·Phase: PHASE3
-
Flow Controlled Ventilation in Cardiac Surgery
NCT04306757 ·Status: COMPLETED ·Phase: NA
-
Effect of Individualized Positive End-expiratory Pressure (PEEP) in Patients Who Have an Intrinsic PEEP During One-lung Ventilation
NCT07638176 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Multicenter Randomized Controlled Clinical Trial of the Impact of Minimally Invasive Abdominal Surgery Esophageal Pressure Monitoring Guided Individualized PEEP on Postoperative Pulmonary Complications in Obese Patients
NCT06996288 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation
NCT03182062 ·Status: UNKNOWN ·Phase: NA
-
LTV (Low Tidal Volüme) Ventilation and Diaphragmatic Motion in CABG (Coronary Artery Bypass Grafting)
NCT07067684 ·Status: COMPLETED ·Phase: NA
-
Correlation of EtCO₂- and P(A-a)O₂-Based Dead Space Calculations in Mechanically Ventilated ICU Patients
NCT06947486 ·Status: COMPLETED
-
Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients
NCT03202641 ·Status: TERMINATED ·Phase: NA
-
Deep Breathing With and Without Pressure Support and PEEP for Preoxygenation in Obese Patients
NCT07380425 ·Status: COMPLETED ·Phase: NA
-
Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes
NCT01522222 ·Status: COMPLETED ·Phase: NA
-
Open Lung PEEP in Thoracic Surgery
NCT03184974 ·Status: COMPLETED
-
Extravascular Lung Water and Pulmonary Vascular Permeability After Minimally Invasive Cardiac Surgery
NCT02155387 ·Status: UNKNOWN
-
Individualized Perioperative Open Lung Ventilatory Strategy
NCT02158923 ·Status: COMPLETED ·Phase: NA
-
Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
NCT03165760 ·Status: COMPLETED ·Phase: NA
-
Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
NCT07186933 ·Status: RECRUITING ·Phase: NA
-
The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics
NCT05776589 ·Status: UNKNOWN