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Clinical Trials/NCT01789801
NCT01789801
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country74 target enrollmentFebruary 21, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radial Artery
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
74
Locations
1
Primary Endpoint
Only one attempt at arterial puncture was necessary (yes/no)
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

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.

Detailed Description

test

Registry
clinicaltrials.gov
Start Date
February 21, 2014
End Date
June 8, 2016
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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

Time Frame: Day 0 - end of procedure

Secondary Outcomes

  • 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)

Study Sites (1)

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