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

NCT01789801 | Completed

• 2 other identifiers: LOCAL/2012/RGG-012012-A01525-38
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Artery; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Only one attempt at arterial puncture was necessary (yes/no)

  Day 0 - end of procedure

Secondary Outcomes (8)

• 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

• Patient satisfaction

  Day 0 - end of procedure

• Operator satisfaction

  Day 0 - end of procedure

Study Arms (2)

Palpation only

ACTIVE COMPARATOR

Patients randomized to this arm will have radial artery puncture via palpation of arteries. Intervention: RAP palpation only

Procedure: RAP palpation only

Ultrasound guidance

EXPERIMENTAL

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

Interventions

RAP palpation only PROCEDURE

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.

Also known as: Radial artery puncture via palpation of arteries only

Palpation only

RAP with ultrasound guidance PROCEDURE

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.

Also known as: radial artery puncture with ultrasound guidance.

Ultrasound guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Related Publications (2)

• Genre Grandpierre R, Bobbia X, Muller L, Markarian T, Occean BV, Pommet S, Roger C, Lefrant JY, de la Coussaye JE, Claret PG. Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial. PLoS One. 2019 Mar 20;14(3):e0213683. doi: 10.1371/journal.pone.0213683. eCollection 2019.

  PMID: 30893349 RESULT

• 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.

  PMID: 34637140 DERIVED

MeSH Terms

Interventions

LDL-Receptor Related Protein-Associated Protein

Intervention Hierarchy (Ancestors)

Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Heymann Nephritis Antigenic Complex; Autoantigens; Antigens; Biological Factors

Study Officials

• Romain Genre-Grandpierre, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2013
• First Posted: February 12, 2013
• Study Start: February 21, 2014
• Primary Completion: June 8, 2016
• Study Completion: June 8, 2016
• Last Updated: November 19, 2025

Record last verified: 2016-06

Locations

FR (1)