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临床试验/NCT03023670
NCT03023670已完成不适用

Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年1月最近更新:
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
68
试验地点
1
主要终点
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative

研究概览

简要总结

The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system

详细描述

The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:

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, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Elective cardiac surgery
  • Ventricular septal defect (VSD).
  • Atrial septal defect (ASD)

排除标准

  • Cyanotic heart disease.
  • Patients with preoperative chest problems.
  • Patients with known renal or hepatic dysfunctions.
  • Planned off-pump cardiac surgery.
  • Emergency cardiac surgery.

研究组 & 干预措施

Group A

Active Comparator

This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass

干预措施: cardiopulmonary bypass (Procedure)

Group B

Active Comparator

This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.

干预措施: cardiopulmonary bypass (Procedure)

结局指标

主要结局

Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative

时间窗: preoperative and within the first 7 days postoperative

次要结局

  • Arterial blood gases(Within the first 7 days postoperative)
  • Mechanical ventilation(Within the first 7 days postoperative)
  • Intensive care unit stay(Within the first 7 days postoperative)
  • Intubation time(Within the first 7 days postoperative)

研究者

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

Sayed Kaoud Abd-Elshafy

Associate profossor of anesthesiology and critical care

Assiut University

研究点 (1)

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