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 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Radial Artery
Ultrasonography
Procedure: Artery puncture with ultrasound guidance
Procedure: Artery puncture without ultrasound guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ultrasound Guidance for Radial Arterial Blood Sampling

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 74
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With ultrasound guidance
In this group of patients, ultrasound guidance will be used when drawing blood from the radial artery.
Procedure: Artery puncture with ultrasound guidance
Ultrasound device will be used to locate artery for puncture.
Active Comparator: Without ultrasound guidance
In this group of patients, no ultrasound guidance will be used when drawing blood from the radial artery.
Procedure: Artery puncture without ultrasound guidance
Blood drawn from radial artery according to conventional procedure, without ultrasound guidance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189188

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Romain Genre-Grandpierre, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01189188     History of Changes
Other Study ID Numbers: LOCAL/2010/RGG-03, 2010-A00714-35
Study First Received: August 25, 2010
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on April 17, 2014