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临床试验/CTRI/2021/07/035209
CTRI/2021/07/035209进行中(未招募)不适用

Impact of radial artery cannulation on perfusion index

Shri Guru Ram Rai Institute of Medical Health Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年2月8日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
The primary objective is to determine the impact of radial artery cannulation on delta change in digital perfusion index

研究概览

简要总结

After getting approval frominstitutional ethical committee, written informed consent will be obtained fromall those patients and/or attendants  whowill fulfill the inclusion criteria. Exclusion criteria are age <18 or>90, Peripheral vascular diseases  upper limb surgeries planned radial arteryharvesting recent trans radial intervention, recent acute myocardial infarctionor percutaneous coronary intervention (PCI), active malignancy, autoimmunedisease, bleeding disorders, recent stroke, functional impairment of the non-dominantarm, pregnancy, severe anemia or thrombocytopenia. Radial artery cannulation will be done in the non-dominant hand of thesubject using catheter-over-needle technique - 20-gauge, 1.75-in. (4.45-cm)polyurethane catheter over 22-gauge introducer needle or catheter-over-wiretechnique (modified Seldinger) - 20-gauge peripheral artery catheter kit withintegrated wire and catheter. Perfusion index will be measured using hand heldpulse oximeter placed on the index finger 1 minute before the intervention(baseline) and  at 1, 10 and 30 minutesafter the intervention. The PI ratio will be calculatedas the ratio between the PI at 10 minutes after intervention and the baselinePI. Comparison between the values of PI before and after the intervention will be done and statisticallyassessed. A comparison between the cannulated and non cannulated limb will alsobe performed in every patient.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing surgery and requiring blood pressure monitoring.

排除标准

  • Peripheral vascular diseases upper limb surgeries planned radial artery harvesting recent trans radial intervention, recent acute myocardial infarction or percutaneous coronary intervention (PCI), active malignancy, autoimmune disease, bleeding disorders, recent stroke, functional impairment of the non-dominant arm, pregnancy, severe anemia or thrombocytopenia.

结局指标

主要结局

The primary objective is to determine the impact of radial artery cannulation on delta change in digital perfusion index

时间窗: pre insertion, 1, 10, 30 mins after insertion

次要结局

  • Secondary objectives is to study change in perfusion index with time (pre insertion, 1, 10, 30 mins after insertion) after radial artery cannulation and to compare perfusion index in cannulated and non-cannulated hand as well as in different digits(pre insertion, 1, 10, 30 mins after insertion)

研究者

发起方
Shri Guru Ram Rai Institute of Medical Health Sciences
申办方类型
Private medical college

研究点 (1)

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