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临床试验/NCT01789801
NCT01789801已完成不适用

A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2014年2月21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
发起方
入组人数
74
试验地点
2
主要终点
Only one attempt at arterial puncture was necessary (yes/no)

研究概览

简要总结

Previous studies have demonstrated that an experienced ultrasound operator is able to efficiently perform radial arterial puncture on patients where an initial operator failed to puncture arteries via simple palpation.

The objective of this study is to compare "difficult-to-puncture" patients randomized into two groups: one group where ultrasound is used to aid artery localisation, and one group where only palpation is used.

详细描述

test

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient's health status necessitates an arterial blood sample AND his/her radial arteries are deemed unpalpable OR two previous attempts at radial arterial puncture by a nurse resulted in failure

排除标准

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, or any kind of guardianship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Arterial puncture is required on femoral, humeral or axillary arteries
  • The patient is in cardiac arrest
  • The patient has known circulatory problems, ischemia, local infection
  • The patient has a severe bleeding or hemostasis disorder (hemophilia, hypoprothrombinemia, platelets <50,000)
  • The patient is an upper limb amputee, or his/her arm is in a cast
  • The patient has known allergies to methyl or propylbenzoate, propylene glycol or chlorexhidine gluconate

研究组 & 干预措施

Palpation only

Active Comparator

Patients randomized to this arm will have radial artery puncture via palpation of arteries.

Intervention: RAP palpation only

干预措施: RAP palpation only (Procedure)

Ultrasound guidance

Experimental

Patients randomized to this arm will have radial artery puncture with ultrasound guidance for artery localisation.

Intervention: RAP with ultrasound guidance

干预措施: RAP with ultrasound guidance (Procedure)

结局指标

主要结局

Only one attempt at arterial puncture was necessary (yes/no)

时间窗: Day 0 - end of procedure

次要结局

  • Length of time necessary for the procedure(Day 0 - end of procedure)
  • Presence/absence of complications(Day 0 - end of procedure)
  • The number of catheters used(Day 0 - end of procedure)
  • Was additional assistance necessary? yes/no(Day 0 - end of procedure)
  • Number of skin punctures(Day 0 - end of procedure)
  • Patient satisfaction(Day 0 - end of procedure)
  • Operator satisfaction(Day 0 - end of procedure)
  • Patient pain evaluation(Day 0 - end of procedure)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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