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临床试验/NCT04962542
NCT04962542已完成不适用

Comparison Between the Effect of Different Strategies of Ventilation During Cardiopulmonary Bypass on Arterial Oxygenation and Postoperative Pulmonary Dysfunction In Pediatric Patients With Congenital Non-cyanotic Heart Diseases

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.

研究概览

简要总结

Postoperative pulmonary dysfunction (PPD) is a widely reported complication of cardiopulmonary bypass (CPB) although there is improvement in perioperative management, that leads to increased morbidity and mortality in cardiac surgery.

Many surgical-related factors can predispose to postoperative pulmonary complications such as the effects of general anesthesia combined with the effects of a median sternotomy, CPB, and the use of topical cooling for myocardial protection.

Main clinical manifestations of PPD include atelectasis, pleural effusion, and postoperative hypoxemia without clinical symptoms in addition to acute respiratory distress syndrome which is rare to happen but leads to high mortality Different strategies including perioperative management of mechanical ventilation (MV), restrictive transfusion, technical modifications of CPB, and medication administration such as steroids and aprotinin have been developed to lessen impairment of pulmonary function.

A recent meta-analysis identified improvement in oxygenation after weaning from CPB when low tidal volume (LTV) ventilation was maintained or after lung recruitment maneuvers (LRM), as compared to when there was no ventilation (noV). Also, maintaining mechanical ventilation may reduce the inflammation response and tissue damage. So far, available researches regarding whether ventilation during CPB could improve respiratory outcomes is still controversial especially in pediatric patients undergoing corrective surgeries for congenital heart defects.

详细描述

Our study is designed to determine the effect of different strategies of ventilation during CPB on arterial oxygenation and PPD in pediatrics undergoing corrective cardiac surgeries for non-cyanotic congenital anomalies.

Preoperative:

First, a proper and detailed history from the parents will be taken followed by a full and detailed examination of the child then the investigators will check all investigations including complete blood count(CBC), coagulation profile, liver enzymes, kidney function tests, chest X-ray (CXR), echocardiography, and blood grouping.

All patients will be premedicated with atropine 0.01 mg/kg, and midazolam 0.02 mg/kg intramuscular(IM), 30 minutes before induction of anesthesia.

Intraoperative:

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American society of anesthesiologist(ASA) II, III.
  • Patients with non-cyanotic congenital heart defects undergoing corrective surgeries during CPB [Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), Common A trio ventricular canal (CAVC)].

排除标准

  • Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
  • ASA IV. Patients with congenital cyanotic heart defects. Parents refusal.

结局指标

主要结局

partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.

时间窗: 5 minutes after weaning from CPB

measuring PaO2/FIO2 ratio in arterial blood gas sample

次要结局

  • PaO2/FIO2 ratio(1 hour after arrival to ICU)
  • Chest x-ray(1 hour after arrival to ICU)
  • oxygenation index(1 hour after arrival to ICU)

研究者

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

Mohamed sabry abdelsalam

Principal Investigator

Cairo University

研究点 (2)

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