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Radial ArteryECHO-PARDIFNCT01789801

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

A study testing RAP palpation only and RAP with ultrasound guidance in people with Radial Artery and Ultrasonography, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Radial Artery, Ultrasonography
What is being tested?
RAP palpation only and RAP with ultrasound guidance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteFrance
Study dates
21 Feb 2014to 8 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard, 30029

Other trials in France

About this study

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.

Read the detailed description

test

Being tested
RAP palpation only, RAP with ultrasound guidance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAP palpation onlyProcedure or surgery

    Also called Radial artery puncture via palpation of arteries 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 guidanceProcedure or surgery

    Also called radial artery puncture 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.

Study groups in NCT01789801
Study groupRoleWhat they receive
Palpation onlyActive comparatorPatients randomized to this arm will have radial artery puncture via palpation of arteries. Intervention: RAP palpation only
Receives: Procedure: RAP palpation only
Ultrasound guidanceExperimentalPatients randomized to this arm will have radial artery puncture with ultrasound guidance for artery localisation. Intervention: RAP with ultrasound guidance
Receives: Procedure: RAP with ultrasound guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 0 - end of procedure

Secondary outcomes (8)
  1. Number of skin punctures

    Measured: Day 0 - end of procedure

  2. Length of time necessary for the procedure

    Measured: Day 0 - end of procedure

  3. Presence/absence of complications

    Presence/absence of complications including hematoma, nerve injury, vagal reaction, pseudo-aneurysm.

    Measured: Day 0 - end of procedure

  4. Patient satisfaction

    Patient satisfaction is evaluated using a visual analog scale.

    Measured: Day 0 - end of procedure

  5. Operator satisfaction

    Operator satisfaction is estimated using a visual analog scale.

    Measured: Day 0 - end of procedure

  6. Patient pain evaluation

    Patients are asked to evaluate the experienced pain level using a visual analog scale.

    Measured: Day 0 - end of procedure

  7. The number of catheters used

    Measured: Day 0 - end of procedure

  8. Was additional assistance necessary? yes/no

    Measured: Day 0 - end of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study start21 Feb 2014
  3. Primary completion8 Jun 2016
  4. Study completion8 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789801
Sponsor's protocol ID
LOCAL/2012/RGG-01
Other IDs
2012-A01525-38
Acronym
ECHO-PARDIF
Status last verified
Jun 2016
First submitted
9 Feb 2013
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30893349
  • 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.

    PubMed 34637140

Questions about this trial

What is this clinical trial studying?

A study testing RAP palpation only and RAP with ultrasound guidance in people with Radial Artery and Ultrasonography, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Only one attempt at arterial puncture was necessary (yes/no) (time frame: Day 0 - end of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789801, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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