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临床试验/NCT03620383
NCT03620383已完成1 期

Radial Artery Vasodilation With Distal Topical Heat Study

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年8月3日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
45
试验地点
2
主要终点
Radial Artery Cross Sectional Area

研究概览

简要总结

The purpose of this study is to collect data about the efficacy of utilizing distal topical heat application for dilatation of the radial artery. Transradial arterial access is widely accepted as the standard of care for cardiac catheterization procedures due to its increased patient comfort and significantly decreased risk of major vascular complications, and has been recently utilized in increasing volume by the interventional radiology community throughout the world. Due to the small size of the radial artery, catheterization may sometimes be technically difficult. Pre-procedure dilatation can make catheterization significantly easier, and studies have demonstrated the successful ability to dilate the radial artery with the use of topical nitroglycerin and lidocaine. However, the investigators hypothesize that utilizing topical heat applied distally can create a physiologic vasodilatation similar to that created with nitroglycerin and lidocaine, but at a significantly lower cost and with less risk due to no need for application of a medication which has a systemic effect with known side effects. The purpose of this study is to test the efficacy of radial artery vasodilatation with distal topical heat application.

详细描述

The study will be designed to detect a significant increase in the radial artery diameter of healthy volunteers after the application of a warm heat pack in the palmar aspect of the hand compared to a control group without heat applied to the hand. Employees and students at OHSU will be considered for enrollment as volunteers for this minimal risk study. Informed consent will be obtained from healthy volunteers prior to enrollment. After enrollment, the healthy volunteers will be randomly assigned in a 2:1 ratio to the heat group (Group 1) or the control group (Group 2), respectively. A brief medical history will be obtained from all volunteers, including age, sex, medications, prior interventions, prior surgeries, previous medical diagnoses, allergies, and any history of prior transradial procedures. For protection of confidential health information, brief medical history will be obtained in a private area. The volunteers will then be seated and the left hand placed supinated in a comfortable position on a table. A limited ultrasound of the left radial artery will be performed using grayscale ultrasound. A skin mark will be made with a marker to identify the measurement site. All volunteers will then be given a commercially available warm heat pack and asked to hold gently in their left hand. For the control group (Group 2), the warm heat pack will not be activated. For the heat group (Group 1), the warm heat back will be activated prior to placing in the volunteer's hand. Two investigators will be present. One investigator will be measuring radial artery diameter and will not be aware if the heat pack is activated. The second investigator will be aware of the volunteer's randomly assigned group and will activate the heat pack for the volunteer if they are assigned to Group 1. Over a period of 20 minutes, repeat ultrasound of the left radial artery will be performed in 5 minute intervals.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers who are 18-99 years old

排除标准

  • Prior left transradial access for procedure

研究组 & 干预措施

Heat

Experimental

Distal topical heat application

干预措施: Topical Heat (Procedure)

No Heat

No Intervention

Inactive heat pack to blind the investigator.

结局指标

主要结局

Radial Artery Cross Sectional Area

时间窗: 20 minutes after application of topical heat

Radial artery cross sectional area after 20 minutes with or without heat application

次要结局

未报告次要终点

研究者

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

Ramsey Al-Hakim

Assistant Professor

Oregon Health and Science University

研究点 (2)

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