Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye
Bursa, Turkey (Türkiye)
NCT Number: NCT07639489
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Bursa, Turkey (Türkiye)
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Up to 7 days postoperatively
Duration of mechanical ventilation greater than 24 hours
Contact information is provided by the study sponsor or research team.
Fusun Gozen
Other Gov
Association of Intraoperative Mechanical Power With Postoperative Pulmonary Complications and Prolonged Mechanical Ventilation in Coronary Artery Bypass Graft Surgery
Acronym: MP-CABG
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.
Published trials that share one or more normalized conditions with this study.
NCT07721558
Atelectasis, Lung Diseases
View Trial DetailsNCT07676760
Digestive System Diseases, Peritoneal Diseases
View Trial DetailsNCT07660588
Double-Lumen Tube, Lung Collapse
Bangkok, Thailand
View Trial DetailsNCT07620132
Abdominal Surgery, Morality
View Trial Details