Ultrasound Guidance for Radial Arterial Blood Sampling

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01189188

First received: August 25, 2010

Last updated: March 20, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 25, 2010

Last Updated Date

March 20, 2013

Start Date ^ICMJE

August 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Is only one puncture attempt necessary to attain the radial artery? yes/no [ Time Frame: maximum two hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01189188 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The number of puncture attempts required to attain the radial artery [ Time Frame: maximum two hous ] [ Designated as safety issue: Yes ]
Visual Analog Scale score for pain felt by the patient (0.0 to 10.0) [ Time Frame: Maximum two hours ] [ Designated as safety issue: No ]
Visual Analog Scale score for patient satisfaction (0.0 to 10.0) [ Time Frame: Maximum two hours ] [ Designated as safety issue: No ]
Visual Analog Scale score for health professional satisfaction (0.0 to 10.) [ Time Frame: Maximum two hours ] [ Designated as safety issue: No ]
Presence / absence of a hematoma at the site of puncture [ Time Frame: two hours ] [ Designated as safety issue: Yes ]
Presence / absence of other complications [ Time Frame: Two hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ultrasound Guidance for Radial Arterial Blood Sampling

Official Title ^ICMJE

Ultrasound Guidance for Radial Arterial Blood Sampling

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Radial Artery
Ultrasonography

Intervention ^ICMJE

Procedure: Artery puncture with ultrasound guidance
Ultrasound device will be used to locate artery for puncture.
Procedure: Artery puncture without ultrasound guidance
Blood drawn from radial artery according to conventional procedure, without ultrasound guidance.

Study Arm (s)

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

Intervention: Procedure: Artery puncture with ultrasound guidance
Active Comparator: Without ultrasound guidance
In this group of patients, no ultrasound guidance will be used when drawing blood from the radial artery.

Intervention: Procedure: Artery puncture without ultrasound guidance

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

The subject is participating in another study
The subject is in a study exclusion period determined by a previous 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01189188

Other Study ID Numbers ^ICMJE

LOCAL/2010/RGG-03, 2010-A00714-35

Has Data Monitoring Committee

Responsible Party

Centre Hospitalier Universitaire de Nīmes

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Nīmes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Romain Genre-Grandpierre, MD

Centre Hospitalier Universitaire de Nîmes

Information Provided By

Centre Hospitalier Universitaire de Nīmes

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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