Mechanical Power and Pulmonary Complications in CABG Surgery (MP-CABG)

June 6, 2026 updated by: Fusun Gozen

Association of Intraoperative Mechanical Power With Postoperative Pulmonary Complications and Prolonged Mechanical Ventilation in Coronary Artery Bypass Graft Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center prospective observational study enrolls adult patients undergoing elective first-time isolated coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).

Mechanical power (MP) will be calculated as: MP = 0.098 × RR

× VT × [PIP - 0.5 × (Pplat - PEEP)], normalized to predicted body weight (norMP = MP/PBW). Male PBW (kg) = 50 + 0.91 × [height (cm) - 152.4]; female PBW (kg) = 45.5 + 0.91 × [height (cm) - 152.4]. Driving pressure (DP) = Pplat - PEEP.

Ventilatory parameters (VT, RR, peak pressure, plateau pressure, PEEP, FiO2, EtCO2) and arterial blood gases (PaO2/FiO2, PaCO2, lactate) will be recorded at four standardized time points: T1 (post-intubation), T2 (post- sternotomy), T3 (pre-bypass), and T4 (post-bypass). No additional interventions beyond standard clinical care will be applied.

Postoperative outcomes including atelectasis, pneumonia, pleural effusion, prolonged oxygen requirement, need for non-invasive ventilation, re-intubation, duration of mechanical ventilation, and ICU length of stay will be assessed within the first 48 hours.

Sample size: 110 patients (α=0.05, power=80%, expected PPC incidence 35% vs 65% in low vs high MP groups, 20% dropout allowance). Statistical analysis will include Mann-Whitney U or t-test, chi-square or Fisher exact test, and logistic regression. Significance: p<0.05 (two-tailed).

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Bursa, Turkey (Türkiye)
        • Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pulmonary Complication
Time Frame: Within the first 48 hours postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged Mechanical Ventilation
Time Frame: Up to 7 days postoperatively
Duration of mechanical ventilation greater than 24 hours
Up to 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fusun Gozen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-TBEK 2026/01-18 (Other Identifier: Bursa Yuksek Ihtisas Training and Research Hospital Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. This is a single-center observational study conducted at a public hospital. Data sharing is not planned due to institutional privacy regulations and the absence of external funding requiring data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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