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Ultrasound Guidance for Radial Arterial Blood Sampling

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189188
First Posted: August 26, 2010
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • The number of puncture attempts required to attain the radial artery [ Time Frame: maximum two hous ]
  • Visual Analog Scale score for pain felt by the patient (0.0 to 10.0) [ Time Frame: Maximum two hours ]
  • Visual Analog Scale score for patient satisfaction (0.0 to 10.0) [ Time Frame: Maximum two hours ]
  • Visual Analog Scale score for health professional satisfaction (0.0 to 10.) [ Time Frame: Maximum two hours ]
  • Presence / absence of a hematoma at the site of puncture [ Time Frame: two hours ]
  • Presence / absence of other complications [ Time Frame: Two hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: N° ICB )
First Submitted: August 25, 2010
First Posted: August 26, 2010
Last Update Posted: March 26, 2015
Last Verified: March 2015