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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-TBEK 2026/01-18 | Other Identifier | Bursa Yuksek Ihtisas Training and Research Hospital Ethics Committee |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged Mechanical Ventilation | Duration of mechanical ventilation greater than 24 hours | Up to 7 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass at a single tertiary cardiac surgery center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Füsun Gözen, MD (Anesthesiology) | Contact | +902242955000 | fusungozen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye | Bursa | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38011027 | Result | 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. | |
| 35480074 |
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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.
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| 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. |
| 34597688 | 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. |
| 34753416 | 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. |
| 41303250 | 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. |
| 28828361 | 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. |