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临床试验/NCT04969692
NCT04969692已完成不适用

Local Warming Technique for Arterial Cannulation in Adult Patients Under Heart Surgery-A Randomized Controlled Trial

Pusan National University Yangsan Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年7月5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
160
试验地点
1
主要终点
changes of the cross-sectional area of the artery

研究概览

简要总结

Based on the fact that arterial vasodilation can be advantageous for endovascular catheterization and that an increase in body temperature can cause vasodilation by activating the cholinergic active vasodilator system, this study was planned to observe whether there was a significant change in the diameter of artery through ultrasound and to confirm the effectiveness of heating in the traditional palpation technique and the US-guided technique after local warming of the insertion site of arterial catheter in adult patients undergoing cardiac surgery.

详细描述

Arterial cannulation is one of the important clinical techniques commonly used for real-time monitoring of blood pressure changes or when repeated blood tests are required. However, complications such as bleeding, hematoma, and vascular occlusion may occur if the operator has little or no experience in the procedure, or if arterial cannulation is not easy due to the patient's underlying disease and systemic factors. This situation prolongs the anesthesia induction time and may cause great harm to the patient in cases with a high bleeding tendency, such as in cardiac surgery. Various studies have reported various arterial cannulation techniques so far, and there have been many advances in arterial cannulation techniques due to the general use of ultrasound (hereafter US). However, there is still a risk of complications due to inexperience in the use of US or poor vascular status of the patient.

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, Investigator, Outcomes Assessor)

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

  • •Adult patients over 18 years of age undergoing cardiac surgery under general anesthesia

排除标准

  • •If the patient already has an arterial catheter and does not need additional arterial cannulation.
  • •When arterial cannulation is performed on an artery other than the radial artery due to the surgical technique or the patient's condition.
  • •When the patient's condition is urgent, such as emergency surgery, and there is no time to proceed with the research.

研究组 & 干预措施

non-warming group

No Intervention

non-warming of local skin (puncture site)

warming group

Active Comparator

warming to increase local skin (puncture site) temperature

干预措施: warming to increase local skin (puncture site) temperature (Procedure)

结局指标

主要结局

changes of the cross-sectional area of the artery

时间窗: from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)

Investigator measures where there is a significant increase in the cross-sectional area of the artery due to warming using US.

Success rate of first trial for arterial cannulation

时间窗: from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)

Investigator measures success rate of first trial for arterial cannulation.

changes of the diameter of the artery

时间窗: from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour)

Investigator measures where there is a significant increase in the diameter of the artery due to warming using US.

次要结局

  • Complications related with arterial cannulation(from time point of warming to success of arterial cannulation (the day of surgery, up to 1hour))

研究者

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

Kim Hee Young

Clinical associate professor

Pusan National University Yangsan Hospital

研究点 (1)

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