NCT01189188

Brief Summary

The investigators aim to determine if ultrasound guidance results in improved technique when drawing blood via a radial artery puncture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2010

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

August 25, 2010

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Is only one puncture attempt necessary to attain the radial artery? yes/no

    maximum two hours

Secondary Outcomes (6)

  • The number of puncture attempts required to attain the radial artery

    maximum two hous

  • Visual Analog Scale score for pain felt by the patient (0.0 to 10.0)

    Maximum two hours

  • Visual Analog Scale score for patient satisfaction (0.0 to 10.0)

    Maximum two hours

  • Visual Analog Scale score for health professional satisfaction (0.0 to 10.)

    Maximum two hours

  • Presence / absence of a hematoma at the site of puncture

    two hours

  • +1 more secondary outcomes

Study Arms (2)

With ultrasound guidance

EXPERIMENTAL

In this group of patients, ultrasound guidance will be used when drawing blood from the radial artery.

Procedure: Artery puncture with ultrasound guidance

Without ultrasound guidance

ACTIVE COMPARATOR

In this group of patients, no ultrasound guidance will be used when drawing blood from the radial artery.

Procedure: Artery puncture without ultrasound guidance

Interventions

Ultrasound device will be used to locate artery for puncture.

With ultrasound guidance

Blood drawn from radial artery according to conventional procedure, without ultrasound guidance.

Without ultrasound guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has signed consent
  • The subject is affiliated with a social security system
  • Health status necessitates an arterial blood sample for diagnostic, prognostic or therapeutic reasons

You may not qualify if:

  • The subject is participating in another study
  • The subject is under guardianship
  • The subject refuses to sign consent
  • Impossible to correctly inform the patient
  • The patient is pregnant, breastfeeding, or parturient
  • Allergies to one or more of the following: methyl, propylbenzoate, propylene glycol, chlorhexidine gluconate
  • Contraindication for an arterial puncture (at the radial artery)
  • Cardio-respiratory arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

Related Publications (2)

  • Bobbia X, Grandpierre RG, Claret PG, Moreau A, Pommet S, Bonnec JM, Bayard RP, Lefrant JY, Muller L, de La Coussaye JE. Ultrasound guidance for radial arterial puncture: a randomized controlled trial. Am J Emerg Med. 2013 May;31(5):810-5. doi: 10.1016/j.ajem.2013.01.029. Epub 2013 Mar 25.

  • Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

Study Officials

  • Romain Genre-Grandpierre, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

September 25, 2010

Study Completion

September 25, 2010

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations