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临床试验/NCT05349773
NCT05349773已完成不适用

The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?

Mansoura University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年5月19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
32
试验地点
1
主要终点
heart rate

研究概览

简要总结

This study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP).

详细描述

Coronary artery bypass graft surgery (CABG) is the most common cardiac surgical procedure. Radial artery of the non-dominant hand with better ulnar collaterals is preferred over the saphenous vein because of long term patency of the radial artery. Radial artery is the preferred second or third arterial conduits for vessels with sub occlusive stenosis.

There are two techniques of radial artery harvesting; open and endoscopic techniques. Endoscopic radial artery harvesting (ERAH) is increasing and it is possible but the evidence regarding its safety is scarce. ERAH is cosmetically better than the open technique.

ERAH technique is performed after applying a tourniquet over the distal arm proximally to the elbow. Allen test will be done first and if the hand has a good blood supply through the ulnar artery, the tourniquet pressure is increased 75-100 mmHg over the systolic pressure and the tourniquet time is kept under one hour and the left radial artery will be endoscopically harvested.

During the time of tourniquet inflation, there is ischemia of the forearm with subsequent cellular ischemic changes like; cellular acidosis, cellular edema, and activation of cellular apoptosis. On deflating the tourniquet, there is reperfusion of the limb and development of ischemic / reperfusion injury with a subsequent increase of inflammatory mediators and reactive oxygen species (ROS). These changes may be associated with some hemodynamic instability that might be dangerous, especially in patients with ischemic heart disease (IHD).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Listed for CABG surgery with the use of ERAH technique.

排除标准

  • Emergency CABG surgery.
  • CABG plus any other cardiac surgery.
  • The use of inopressor drugs before ERAH

结局指标

主要结局

heart rate

时间窗: the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

HR will be recorded at inflating the tourniquet and every five minutes for thirty minutes. HR will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.

systolic blood pressure

时间窗: the changes in SBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

SBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. SBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.

diastolic blood pressure

时间窗: the changes in DBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

DBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. DBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.

次要结局

  • Phenylephrine use(The phenylephrine use ( for SBP less than 100 mmHg) will be recorded for one hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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