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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Radial Artery
• Intervention / Treatment: Procedure: RAP palpation only; Procedure: RAP with ultrasound guidance

Detailed Description

test

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Palpation only; Patients randomized to this arm will have radial artery puncture via palpation of arteries. Intervention: RAP palpation only	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.; Other Names: Radial artery puncture via palpation of arteries only
EXPERIMENTAL: Ultrasound guidance; Patients randomized to this arm will have radial artery puncture with ultrasound guidance for artery localisation. Intervention: RAP with ultrasound guidance	Procedure: 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.; Other Names: radial artery puncture with ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Romain Genre-Grandpierre, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2014
• Primary Completion (ACTUAL): June 8, 2016
• Study Completion (ACTUAL): June 8, 2016

Study Registration Dates

• First Submitted: February 9, 2013
• First Submitted That Met QC Criteria: February 9, 2013
• First Posted (ESTIMATE): February 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2012/RGG-01; 2012-A01525-38 (OTHER: RCB number)