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Mechanical Power and Pulmonary Complications in CABG Surgery

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07639489
Acronym
MP-CABG
Enrollment
110
Registered
2026-06-10
Start date
2026-06-01
Completion date
2026-09-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

intraoperative ventilation, lung-protective ventilation

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.

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).

Interventions

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.

Sponsors

Fusun Gozen
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pulmonary ComplicationWithin the first 48 hours postoperativelyOccurrence 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

Secondary

MeasureTime frameDescription
Prolonged Mechanical VentilationUp to 7 days postoperativelyDuration of mechanical ventilation greater than 24 hours

Countries

Turkey (Türkiye)

Contacts

CONTACTFüsun Gözen, MD (Anesthesiology)
fusungozen@gmail.com+902242955000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026