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临床试验/NCT03824301
NCT03824301已完成不适用

Comparative Study Between Different Modes of Ventilation During Cardiopulmonary Bypass and Its Effect on Postoperative Pulmonary Dysfunction

Ain Shams University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
lung ultrasonography

研究概览

简要总结

66 patients divided into 3 groups with different modes of ventilation.

详细描述

Sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C: control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2), Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • •Patients undergoingvalve surgeries
  • •Patients undergoing coronary artery bypass grafting surgeries

排除标准

  • •Emergency cases.
  • •Off-pump surgeries.
  • •Patients with chronic lung diseases with forced expiratory volume in first second (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.
  • •Massive blood transfusion during surgery.
  • •Complicated surgeries.
  • •Redo surgeries.
  • •Patients with decompensated heart failure prior to surgery.
  • •Patients refusal

研究组 & 干预措施

No ventilation

No Intervention

During cardiopulmonary bypass period the patients were disconnected from ventilator

Volume-controlled ventilation

Active Comparator

During cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation

干预措施: Volume controlled ventilation (Device)

Pressure-controlled ventilation

Active Comparator

During cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation

干预措施: Pressure controlled ventilation (Device)

结局指标

主要结局

lung ultrasonography

时间窗: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.

Lung ultrasonography to detect any lung changes from baseline or development of consolidation, pulmonary edema or pleural effusion

chest x-ray

时间窗: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.

Chest x ray to detect any lung pathology or changes from baseline like pleural effusion, pulmonary edema or pneumonia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Anis Metry

Assistant professor

Ain Shams University

研究点 (1)

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