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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Mechanical Power; Postoperative Pulmonary Complications (PPCs)
• Intervention / Treatment: Other: Driving pressure-based personalized PEEP strategy; Other: Conventional lung protective mechanical ventilation strategy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: eralp cevikkalp; Phone Number: 905054554875; Email: eralpcevikkalp@hotmail.com
• Study Contact Backup: Name: İrem Aydoğmuş; Email: driremaydogmus@hotmail.com

Study Locations

• Turkey (Türkiye)
  • nilüfer
    • Bursa, nilüfer, Turkey (Türkiye), 16000
      • Bursa City Hospital
      • Contact: eralp cevikkalp; Phone Number: 905054554875; Email: eralpcevikkalp@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical Power Group; Driving pressure-guided individualized PEEP group	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: Lung Protective Ventilation; Conventional lung-protective ventilation group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pulmonary complications	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	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	Duration of İCU lenght of stay	From postoperative ICU admission to ICU discharge, assessed up to 30 days
Duration of mechanical ventilation	Duration of mechanical ventilation	Time from intubation to successfull extubation
30 day mortality	30 day mortality	postoperative 30 day mortality
Hospital lenght of stay	Hospital lenght of stay	From hospital admission to hospital discharge, assessed up to 30 days

Collaborators and Investigators

• Sponsor: Bursa City Hospital
• Investigators: Study Chair: eralp cevikkalp, Burs City Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: mechanical power; postoperative pulmonary complications; cardica surgery
• Other Study ID Numbers: 25.03.2026 2026-6/7; 26-AKD-57 (Other Identifier: Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No