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NCT Number: NCT07639489

Mechanical Power and Pulmonary Complications in CABG 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye

Bursa, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Prolonged Mechanical Ventilation

    Time frame: Up to 7 days postoperatively

    Duration of mechanical ventilation greater than 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Füsun Gözen, MD (Anesthesiology)

CONTACT

[email protected]

+902242955000

Sponsors and collaborators

Lead sponsor

Fusun Gozen

Other Gov

Registry information

Official study title

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

Acronym: MP-CABG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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