A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples

Not Applicable

Completed

• Conditions: Ultrasonography; Radial Artery
• Interventions: Procedure: RAP with ultrasound guidance; Procedure: RAP palpation only

• Registration Number: NCT01789801
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Previous studies have demonstrated that an experienced ultrasound operator is able to efficiently perform radial arterial puncture on patients where an initial operator failed to puncture arteries via simple palpation.

The objective of this study is to compare "difficult-to-puncture" patients randomized into two groups: one group where ultrasound is used to aid artery localisation, and one group where only palpation is used.

Detailed Description

test

Study Timeline

• Study First Submitted: 2013-02-09
• Study First Submitted QC: 2013-02-09
• Study First Posted: 2013-02-12
• Study Start: 2014-02-21
• Status Verified: 2016-06
• Primary Completion: 2016-06-08
• Study Completion: 2016-06-08
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient's health status necessitates an arterial blood sample AND his/her radial arteries are deemed unpalpable OR two previous attempts at radial arterial puncture by a nurse resulted in failure

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, or any kind of guardianship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• Arterial puncture is required on femoral, humeral or axillary arteries
• The patient is in cardiac arrest
• The patient has known circulatory problems, ischemia, local infection
• The patient has a severe bleeding or hemostasis disorder (hemophilia, hypoprothrombinemia, platelets <50,000)
• The patient is an upper limb amputee, or his/her arm is in a cast
• The patient has known allergies to methyl or propylbenzoate, propylene glycol or chlorexhidine gluconate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guidance	RAP with ultrasound guidance	Patients randomized to this arm will have radial artery puncture with ultrasound guidance for artery localisation. Intervention: RAP with ultrasound guidance
Palpation only	RAP palpation only	Patients randomized to this arm will have radial artery puncture via palpation of arteries. Intervention: RAP palpation only

Primary Outcome Measures

Name	Time	Method
Only one attempt at arterial puncture was necessary (yes/no)	Day 0 - end of procedure

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	Day 0 - end of procedure	Patient satisfaction is evaluated using a visual analog scale.
Number of skin punctures	Day 0 - end of procedure
Length of time necessary for the procedure	Day 0 - end of procedure
Presence/absence of complications	Day 0 - end of procedure	Presence/absence of complications including hematoma, nerve injury, vagal reaction, pseudo-aneurysm.
The number of catheters used	Day 0 - end of procedure
Was additional assistance necessary? yes/no	Day 0 - end of procedure
Operator satisfaction	Day 0 - end of procedure	Operator satisfaction is estimated using a visual analog scale.
Patient pain evaluation	Day 0 - end of procedure	Patients are asked to evaluate the experienced pain level using a visual analog scale.

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France