Mechanical Power and Pulmonary Complications in CABG Surgery

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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.

Первичные конечные точки

• Postoperative Pulmonary Complication [Срок оценки: Within the first 48 hours postoperatively]

Вторичные конечные точки (1)

• Prolonged Mechanical Ventilation [Срок оценки: Up to 7 days postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye — Bursa

Публикации

• 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. PMID 38011027
• 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 PMID 35480074
• 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. PMID 34597688
• 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. PMID 34753416
• 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. PMID 41303250
• 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. PMID 28828361

Идентификаторы

NCT: NCT07639489 · 2024-TBEK 2026/01-18 · 2024-TBEK 2026/01-18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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