Mechanical Power and Pulmonary Complications in CABG Surgery

NCT07639489 | Not Yet Recruiting

• 1 other identifier: 2024-TBEK 2026/01-18
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study evaluates the association between intraoperative mechanical power (MP) - a composite measure of the total energy delivered to the lungs during mechanical ventilation - and postoperative pulmonary complications (PPCs) and prolonged mechanical ventilation in adult patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). Intraoperative ventilatory parameters including tidal volume, respiratory rate, airway pressures, and PEEP will be recorded and used to calculate MP and driving pressure (DP). No additional interventions will be applied beyond standard clinical care.

Conditions

Postoperative Pulmonary Complications; Coronary Artery Bypass Graft Surgery (CABG); Prolonged Mechanical Ventilation

Keywords

intraoperative ventilation; lung-protective ventilation

Outcome Measures

Primary Outcomes (1)

• Postoperative Pulmonary Complication

  Occurrence of at least one of the following within the first 48 hours postoperatively: atelectasis, pleural effusion, pneumonia, prolonged oxygen requirement, need for non-invasive ventilation (NIV), or re-intubation

  Within the first 48 hours postoperatively

Secondary Outcomes (1)

• Prolonged Mechanical Ventilation

  Up to 7 days postoperatively

Study Arms (1)

CABG Patients

Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass. Intraoperative ventilatory parameters will be recorded to calculate mechanical power and driving pressure.

Other: Intraoperative Mechanical Ventilation Monitoring

Interventions

Intraoperative Mechanical Ventilation Monitoring OTHER

Intraoperative ventilatory parameters (tidal volume, respiratory rate, plateau pressure, PEEP) are routinely recorded during CABG surgery. Mechanical power and driving pressure are calculated from these parameters. No additional intervention is applied beyond standard clinical care.

CABG Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass at a single tertiary cardiac surgery center

You may qualify if:

• Age 18 years or older
• Scheduled for elective, first-time isolated CABG surgery
• Use of cardiopulmonary bypass (CPB)
• Intraoperative mechanical ventilation applied under general anesthesia with recordable ventilator data
• Provision of written informed consent

You may not qualify if:

• Emergency cardiac surgery
• Off-pump CABG (without CPB)
• Preoperative requirement for invasive mechanical ventilation
• Advanced chronic lung disease
• Incomplete or unreliable intraoperative ventilatory data
• Intraoperative use of advanced non-standard support (ECMO)

Sponsors & Collaborators

• Fusun Gozen: lead

Study Sites (1)

Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye

Bursa, Turkey (Türkiye)

Location

Related Publications (6)

• Elefterion B, Cirenei C, Kipnis E, Cailliau E, Bruandet A, Tavernier B, Lamer A, Lebuffe G. Intraoperative Mechanical Power and Postoperative Pulmonary Complications in Noncardiothoracic Elective Surgery Patients: A 10-Year Retrospective Cohort Study. Anesthesiology. 2024 Mar 1;140(3):399-408. doi: 10.1097/ALN.0000000000004848.

  PMID: 38011027 RESULT

• Schuijt MTU, Hol L, Nijbroek SG, Ahuja S, van Meenen D, Mazzinari G, Hemmes S, Bluth T, Ball L, Gama-de Abreu M, Pelosi P, Schultz MJ, Serpa Neto A. Associations of dynamic driving pressure and mechanical power with postoperative pulmonary complications-posthoc analysis of two randomised clinical trials in open abdominal surgery. EClinicalMedicine. 2022 Apr 16;47:101397. doi: 10.1016/j.eclinm.2022.101397. eCollection 2022 May.

  PMID: 35480074 RESULT

• Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.

  PMID: 34597688 RESULT

• Zhu Y, Peng W, Zhen S, Jiang X. Mechanical power normalized to predicted body weight is associated with mortality in critically ill patients: a cohort study. BMC Anesthesiol. 2021 Nov 10;21(1):278. doi: 10.1186/s12871-021-01497-1.

  PMID: 34753416 RESULT

• Li T, Zhailauova A, Wachruschew I, Kuanyshbek A, Tulegenov S, Bukirova P, Zhakupbekov B, Nikitin I, Ayaganov D, Kapyshev T, Samalavicius R, Melnikov AL, Aslanidis T. Impact of Ventilation Discontinuation During Cardiopulmonary Bypass: A Prospective Observational Study. J Clin Med. 2025 Nov 19;14(22):8215. doi: 10.3390/jcm14228215.

  PMID: 41303250 RESULT

• Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.

  PMID: 28828361 RESULT

Central Study Contacts

Füsun Gözen, MD (Anesthesiology)

CONTACT

+902242955000; fusungozen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)