Ultrasound Guidance for Radial Arterial Blood Sampling

Ultrasonography Clinical Trial

Official title:

Ultrasound Guidance for Radial Arterial Blood Sampling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189188
• Other study ID #: LOCAL/2010/RGG-03
• Secondary ID: 2010-A00714-35
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: March 25, 2015
• Start date: August 2010
• Est. completion date: October 2010

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Radial Artery
• Ultrasonography

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is only one puncture attempt necessary to attain the radial artery? yes/no		maximum two hours	Yes
Secondary	The number of puncture attempts required to attain the radial artery		maximum two hous	Yes
Secondary	Visual Analog Scale score for pain felt by the patient (0.0 to 10.0)		Maximum two hours	No
Secondary	Visual Analog Scale score for patient satisfaction (0.0 to 10.0)		Maximum two hours	No
Secondary	Visual Analog Scale score for health professional satisfaction (0.0 to 10.)		Maximum two hours	No
Secondary	Presence / absence of a hematoma at the site of puncture		two hours	Yes
Secondary	Presence / absence of other complications		Two hours	Yes