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临床试验/NCT05127668
NCT05127668已完成不适用

Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)

Glasgow Caledonian University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年3月29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
34
试验地点
2
主要终点
Name of Measurement: Change in measurement of vein diameter by ultrasound

研究概览

简要总结

To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

详细描述

Failure to cannulate to gain intra-venous access is a common occurrence in patients undergoing chemotherapy, obese patients, intravenous drug users and those with chronic medical problems leading to peripheral venous collapse. Difficulty in gaining IV-access is a serious medical consequence since important life-saving drugs, fluids, blood transfusions, and other medication are usually given via the intravenous route. Most chemotherapy units in the UK rely on venous dilation by immersing the forearm of patients with "difficult to cannulate veins" (DTCV) into a bucket of warm water. There are however, limitations in this method such as controlling water temperature and ensuring proper sterility.

A new device Airglove™ has been developed which directs warm air over the forearm in a polythene sleeve causing venodilation. Preliminary studies in chemotherapy patients suggest that the Airglove™ causes venodilation to the extent of the warm water immersion technique, however further evidence is required with testing on normal healthy volunteers.

Aims and Objectives:

To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigator and reviewer were masked to the results

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

  • Participants > 18 years old
  • Able to give written informed consent
  • Able to understand and complete questionnaire forms independently

排除标准

  • Participants < 18 years old
  • Participants with cancer and/or undergoing chemotherapy
  • Participants with difficult to cannulate veins (DTCV)
  • Participants with lymphoedema in either hand
  • Participants with pre-existing Raynaud's disease
  • Participants with Diabetes (Type 1 & 2)
  • Participants with generalised anxiety disorder
  • Participants with diagnosis of hypertension
  • Participants with any cardiovascular disease, previous stroke, episodes of DVT, recent treatment for venous thromboembolism (VTE), recently administered heparin, participants on warfarin or any anticoagulant treatment (including NOACs).
  • Participants not able to give written informed consent
  • Participants not able to comprehend or complete questionnaire forms independently

结局指标

主要结局

Name of Measurement: Change in measurement of vein diameter by ultrasound

时间窗: Change from baseline measurements taken within 2 minutes of the intervention

MEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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