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临床试验/NCT03810729
NCT03810729已完成不适用

Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2019年5月15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
236
试验地点
2
主要终点
Number of participants with use of the radial artery as a conduit for CABG

研究概览

简要总结

Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before the surgery, the surgeon needs to choose which vessel will be used for the bypass, including potentially the radial artery in the wrist. Smartphones have been shown in a previous study to be a better way to assess the arteries in the hand than the traditional physical examination, as it is less subjective than simply watching the flushing of the hand. In this study, the investigators will assess the utility of a smartphone application in determining whether there is enough blood flow in the hand prior to using the radial artery for CABG surgery.

详细描述

Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before the surgery, the surgeon needs to choose which vessel will be used for the bypass, including potentially the radial artery in the wrist. Before using this artery, it is important to ensure that there is enough blood flow to the hand to prevent complications. The best way to do this involves the use of ultrasound, but this takes a long time and its availability can be limited. Therefore, the assessment is usually done at the bedside by examining the hand, which relies on the doctor watching the flushing of the hand during compression and release of the artery. Currently, smartphones with cameras are able to assess blood flow by passing light through the skin and observing differences in brightness. This has been shown in a previous study to be a better way to assess the arteries in the hand than the traditional examination, as it is less subjective than simply watching the flushing of the hand. In this study, the investigators will assess the utility of a smartphone application in determining whether there is enough blood flow in the hand prior to using the radial artery for CABG surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Care Provider, 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

入选标准

  • Age greater than or equal to 18 years old
  • Scheduled to undergo coronary artery bypass graft for which the surgeon is considering the use of a radial artery conduit
  • Able and willing to provide written informed consent

排除标准

  • Hemodynamic instability
  • Need for emergent cardiac surgery
  • Known previous removal of the radial or ulnar arteries

结局指标

主要结局

Number of participants with use of the radial artery as a conduit for CABG

时间窗: In-hospital (average of 7 days)

The primary outcome of this study is the use of the radial artery as a conduit in CABG surgery, which will only occur if the ulnar artery is deemed patent by the corresponding test to which the participant has been randomized to receive (i.e. modified Allen's test or smartphone assessment).

次要结局

  • Number of participants with early graft failure(In-hospital (average of 7 days))
  • Number of participants with stroke(In-hospital (average of 7 days))
  • Number of participants with myocardial infarction(In-hospital (average of 7 days))
  • Number of participants with post-operative hand ischemia(In-hospital (average of 7 days))
  • Number of participants with cardiovascular death(In-hospital (average of 7 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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