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

Ultrasonography Clinical Trial

— ECHO-PARDIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789801
• Other study ID #: LOCAL/2012/RGG-01
• Secondary ID: 2012-A01525-38
• Status: Completed
• Phase: N/A
• First received: February 9, 2013
• Last updated: February 7, 2018
• Start date: February 21, 2014
• Est. completion date: June 8, 2016

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

test

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 8, 2016
• Est. primary completion date: June 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radial Artery
• Ultrasonography

Intervention

Procedure:
• RAP palpation only
Skin disinfection by local antiseptic. Identification of the radial artery by palpation. Insertion of the needle positioned at 70 ° with regard to the artery palpated. Check the rise of arterial blood in the syringe.
• RAP with ultrasound guidance
Skin disinfection by local antiseptic. Application of sterile gel. Identification of the artery via ultrasound vascular probe. Center the artery at the center of the screen. Introduction of the syringe at 70 ° with respect to the probe, in center of visualized zone. Check the rise of arterial blood in the syringe.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

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