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临床试验/NCT05265481
NCT05265481已完成不适用

The Effect of Tapping in the Venous Dilatation for Peripheral IV Access

University of Florida1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年11月7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
24
试验地点
1
主要终点
Change in standardized tapping with a device for PIVC

研究概览

简要总结

Peripheral intravenous cannulation (PIVC) is one of the most common interventions in medical practice. Venous dilatation is helpful for successful PIV placement. Several techniques include hot pack application, tourniquet, massaging, and tapping over the vein to increase vein caliber described in the literature. However, none of them has been rigorously studied. Therefore, there is still no 'best practice' on how to effect vein dilation in a standard way.

This study aims to investigate the effect of standardized tapping on venous dilatation with a massage device compared to manual non-standardized tapping and define a standard tapping technique using a device.

In this study, the investigators also aim to investigate the effect of tourniquet application with and without vein tapping effect on peripheral vein caliber as determined by ultrasound measurement.

详细描述

PIVC is one of the most common medical interventions in daily practice. Even though it seems like it should be an easy procedure, PIVC can be challenging.

Venous dilatation optimizes conditions for successful vein cannulation. Several techniques are described to affect venodilation, but none of them are standardized because they are done manually, and there will be individual variations among clinicians.

Tapping over the vein has been reported as an effective method. It has been hypothesized that tapping affects vein vaso-nervorum activation and local histamine release. Tapping or massage over the cannulation site is readily applied in busy medical practice, with a third of nurses using tapping or massage to promote venodilation. Tapping and massage are effective methods of vasodilatation to make the vein more prominent for venipuncture, with tapping more effective than massage (Ichimura et al.) There are limited data concerning the effect of tapping in PIVC and its standardization. In the current literature, there is no standard technique on how tapping should be performed.

Specific Aims:

  • H0: Standardized tapping with a massage device is not an effective technique to dilate the peripheral veins for PIVC compared to manual tapping.
  • H1: Standardized tapping with a device is a more effective technique to dilate peripheral veins for PIVC compared to manual tapping.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •>18 years old,
  • •Giving informed consent,
  • •COVID-19 vaccinated (proof of vaccination must be shown)

排除标准

  • •COVID-19 unvaccinated,
  • •Having unexplained COVID symptom(s) (This will be assessed by asking the ONE.UF screening questions):
  • •Fever or chills
  • •Muscle or body aches
  • •New loss of taste or smell
  • •Sore throat
  • •Congestion or runny nose
  • •Nausea or vomiting
  • •Close contact with a COVID-19 patient in 14 days

研究组 & 干预措施

Baseline

No Intervention

In this phase, the investigators will not apply any venodilation method.

Tourniquet applied

Active Comparator

The investigators will apply a blood pressure cuff tourniquet inflated to 60 mmHg pressure.

干预措施: Tourniquet (Device)

Tourniquet plus manual tapping

Active Comparator

The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein manually.

干预措施: Tourniquet (Device)

Tourniquet plus manual tapping

Active Comparator

The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein manually.

干预措施: Manual Tapping (Device)

Tourniquet plus device tapping

Experimental

The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein with a massage device.

干预措施: Tourniquet (Device)

Tourniquet plus device tapping

Experimental

The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein with a massage device.

干预措施: Device tapping (Device)

结局指标

主要结局

Change in standardized tapping with a device for PIVC

时间窗: 2 hours

The primary outcome is to measure the vein diameters after manual and device tapping and detect the change from baseline in vein diameters.

次要结局

  • Change in the effect of tourniquet application(2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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