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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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- 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.
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
- Conditions
- Radial Artery, Ultrasonography
- 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 group | Role | What they receive |
|---|---|---|
| Palpation only | Active comparator | Patients randomized to this arm will have radial artery puncture via palpation of arteries.
Intervention: RAP palpation only Receives: 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 Receives: Procedure: RAP with ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Only one attempt at arterial puncture was necessary (yes/no)
Measured: Day 0 - end of procedure
Secondary outcomes (8)
Number of skin punctures
Measured: Day 0 - end of procedure
Length of time necessary for the procedure
Measured: Day 0 - end of procedure
Presence/absence of complications
Presence/absence of complications including hematoma, nerve injury, vagal reaction, pseudo-aneurysm.
Measured: Day 0 - end of procedure
Patient satisfaction
Patient satisfaction is evaluated using a visual analog scale.
Measured: Day 0 - end of procedure
Operator satisfaction
Operator satisfaction is estimated using a visual analog scale.
Measured: Day 0 - end of procedure
Patient pain evaluation
Patients are asked to evaluate the experienced pain level using a visual analog scale.
Measured: Day 0 - end of procedure
The number of catheters used
Measured: Day 0 - end of procedure
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.
- First posted12 Feb 2013 (estimated)
- Study start21 Feb 2014
- Primary completion8 Jun 2016
- Study completion8 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radial ArteryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Genre-Grandpierre, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
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 30893349Flumignan 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples
- ClinicalTrials.gov ID
- NCT01789801
- Acronym / sponsor ID
- ECHO-PARDIF / LOCAL/2012/RGG-01
- Conditions
- Radial Artery, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Feb 2014 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 8 Jun 2016 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation only | Active comparator | Procedure: RAP palpation onlyPatients randomized to this arm will have radial artery puncture via palpation of arteries. Intervention: RAP palpation only |
| Ultrasound guidance | Experimental | Procedure: RAP with ultrasound guidancePatients randomized to this arm will have radial artery puncture with ultrasound guidance for artery localisation. Intervention: RAP with ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAP palpation onlyAlso: Radial artery puncture via palpation of arteries onlySkin 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. | Procedure or surgery | Palpation only |
| RAP with ultrasound guidanceAlso: 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. | Procedure or surgery | Ultrasound guidance |
Primary outcome
Only one attempt at arterial puncture was necessary (yes/no)
Time frame: Day 0 - end of procedure
8 secondary outcomes
Number of skin punctures
Time frame: Day 0 - end of procedure
Length of time necessary for the procedure
Time frame: Day 0 - end of procedure
Presence/absence of complications
Time frame: Day 0 - end of procedure
Patient satisfaction
Time frame: Day 0 - end of procedure
Operator satisfaction
Time frame: Day 0 - end of procedure
Patient pain evaluation
Time frame: Day 0 - end of procedure
The number of catheters used
Time frame: Day 0 - end of procedure
Was additional assistance necessary? yes/no
Time frame: Day 0 - end of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 30893349Genre 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.
- Derived from this study: PubMed 34637140Flumignan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Genre-Grandpierre, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
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.