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临床试验/NCT07639489
NCT07639489尚未招募不适用

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

Fusun Gozen1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究者

发起方
Fusun Gozen
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Fusun Gozen

MD of Anesthesiology and Reanimation

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (1)

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