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临床试验/NCT05294718
NCT05294718已完成不适用

External Shunt Versus Internal Shunt for Off Pump Glenn (Original Article)

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Mean SVC Pressure

研究概览

简要总结

A prospective, randomized comparative study where investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.

详细描述

The bidirectional Glenn shunt (BDG) is performed for cyanotic congenital heart defects, with single-ventricle pathology . The BDG is usually performed with cardiopulmonary bypass (CPB) with its associated complications. The conduct of this operation without CPB can be associated with elevation of superior vena caval (SVC) pressure that may lead to neurological damage.

However, the safety of performing BDG without CPB reported by many authors but with some decompression techniques of the SVC at the time of clamping

Objective: investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.

Design A prospective, randomized comparative study Setting: Single tertiary care cardiac center Participants 30 patients with functional single ventricle who will go off pump bidirectional Glenn.

Interventions: The patients will be randomly assigned into two groups: Group I (n = 15), where it will be done with a veno-atrial shunt(internal), and Group II (n = 15), where it will be done with an external shunt. All patients will go a complete neurological examination both preoperatively as well as postoperatively Intraoperative data will be collected and analyzed at the following time points: pre-clamping (post induction), during clamping and after de-clamping of SVC. variables such as arterial oxygen saturation (SaO2), systolic blood pressure (SBP), mean arterial blood pressure (MAP), diastolic blood pressure (DBP), and hematocrit, CVP, SVC pressure, cerebral perfusion pressure (CPP= MAP-CVP), PaO2, PaCO2 and ScvO2 will be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

concealed in opaque closed envelops

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • single-ventricle lesions,
  • good sized branch pulmonary arteries (Magoon's index > 1.5),
  • PA pressures < 20 mmHg,
  • So2 < 80%,
  • age range from (6 months-5years)
  • weight range from (6-21) kg, -All these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.-

排除标准

  • previous cardiac operation,
  • known intracranial pathology,
  • neurologic disease
  • craniofacial anomalies.

结局指标

主要结局

Mean SVC Pressure

时间窗: during SVC clamping procedure

Measurment of superior vena cava pressure during off pumb Glenn

次要结局

  • Mean SVC clamp time(during SVC clamping procedure)
  • mean ABP("baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention)
  • cerebral perfusion pressure("baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Mohamed Elhaddad

Lecturer of Anesthesia, ICU and Pain managment

Kasr El Aini Hospital

研究点 (1)

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