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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014