UltrasonographyNCT04878887
DRA vs PRA for US-guided Radial Artery Catheterization in ICU
A study testing IP-DRA vs IP- PRA in people with Ultrasonography, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane distal radial access (IP-DRA) and in-plane proximal radial access (IP-PRA) catheterization. For IP-DRA , a linear transducer is placed in the radial fossa, which is known as the snuff-box. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Ultrasonography
- What is being tested?
- IP-DRA vs IP- PRA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTunisia
- Study dates
- 26 Mar 2021to 15 Dec 2022
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted in intensive care unit requiring a central venous catheter (CVC)
Who cannot join
- Patients with radial AV shunt for hemodialysis
- Patients with Renaud phenomenon or lymphedema
- Congenital or acquired deformity of arms
- Cannulation site infection, hematoma and surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison Between Ultrasound-guided Distal and Proximal Approaches for Radial Artery Catheterization in Intensive Care Unit
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane distal radial access (IP-DRA) and in-plane proximal radial access (IP-PRA) catheterization.
For IP-DRA , a linear transducer is placed in the radial fossa, which is known as the snuff-box. After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .
Read more
For IP-PRA , a linear transducer is placed in the standard conventional forearm radial.
After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .
Read the detailed description
*Ultrasound-guided catheterization of the radial artery, by proximal approach:
- Patient's hand in hyperextension with slight dorsiflexion of the wrist.
- The placement of the ultrasound probe initially linear in order to obtain the "short axis" image of the artery; then a quarter turn until obtaining a longitudinal "long axis" view.
- The operator must identify the artery using the pulsed wave Doppler;
- Insertion of the needle in the middle of the transducer providing an "in plane" orientation. Thus the needle was advanced slowly and its tip was visualized throughout the procedure. *Ultrasound-guided catheterization of the radial artery, by distal approach:
- If the right hand is along the body / if the left hand is on the trunk.
- The ultrasound probe placed at the level of the anatomical snuffbox by placing the transducer in a linear fashion then rotated coronally until a longitudinal image is obtained *In the 2 groups: - The longitudinal "in plane" approach is used - After visualization of the penetration of the bevel of the needle into the lumen of the artery and the jet of arterial blood into the syringe on aspiration, a flexible metal guide was introduced into the artery through the trocar according to the Seldinger's method. - The correct positioning of the guide in the artery was then confirmed by ultrasound. Any obstacle preventing insertion of the guide system always led to a new puncture.
- Conditions
- Ultrasonography
- Being tested
- IP-DRA vs IP- PRA
- Keywords
- Catheter, radial artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP-DRA vs IP- PRAProcedure or surgery
Catetherization approach in plane : distal radial artery VS proximal radial artery
| Study group | Role | What they receive |
|---|---|---|
| IP-DRA | Other | In plane distal radial artery catherterization Receives: Procedure: IP-DRA vs IP- PRA |
| IP-PRA | Other | In plane proximal radial artery catherterization Receives: Procedure: IP-DRA vs IP- PRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall access time
Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire .
Measured: During the cannulation procedure
Secondary outcomes (4)
2. Puncture Attempts
Which is the number of puncture attempts from first one until the successful one
Measured: During the procedure
3. The guidewire time
Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire
Measured: during the procedure
4. The access time
time between the first skin puncture and the jet of arterial blood
Measured: during the procedure
5. Rare complications
Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation.
Measured: After 01 weeks of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Mar 2021
- Primary completion20 Oct 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trabelsi Becem, University Tunis El Manar
- Investigators
- Mechaal Ben Ali, Professor, Study chair, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878887
- Sponsor's protocol ID
- DRA UTRAC
- Status last verified
- Jun 2023
- First submitted
- 5 May 2021
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deepika K, Palaniappan D, Fuhrman T, Saltzmanm B. Anatomic snuffbox radial artery cannulation. Anesth Analg. 2010 Oct;111(4):1078-9. doi: 10.1213/ANE.0b013e3181ef343a. No abstract available.
PubMed 20870991Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3.
PubMed 24588456Kucuk A, Yuce HH, Yalcin F, Boyaci FN, Yildiz S, Yalcin S. Forty-five degree wrist angulation is optimal for ultrasound guided long axis radial artery cannulation in patients over 60 years old: a randomized study. J Clin Monit Comput. 2014 Dec;28(6):567-72. doi: 10.1007/s10877-014-9552-z. Epub 2014 Jan 11.
PubMed 24414382Sethi S, Maitra S, Saini V, Samra T, Malhotra SK. Comparison of short-axis out-of-plane versus long-axis in-plane ultrasound-guided radial arterial cannulation in adult patients: a randomized controlled trial. J Anesth. 2017 Feb;31(1):89-94. doi: 10.1007/s00540-016-2270-6. Epub 2016 Oct 19.
PubMed 27761661Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
PubMed 28506941Pyles ST, Scher KS, Vega ET, Harrah JD, Rubis LJ. Cannulation of the dorsal radial artery: a new technique. Anesth Analg. 1982 Oct;61(10):876-8. No abstract available.
PubMed 7125255
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison Between Ultrasound-guided Distal and Proximal Approaches for Radial Artery Catheterization in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04878887
- Acronym / sponsor ID
- DRA UTRAC
- Conditions
- Ultrasonography
- Keywords
- Catheter, radial artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 10 May 2021 (actual)
- 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.
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane distal radial access (IP-DRA) and in-plane proximal radial access (IP-PRA) catheterization.
For IP-DRA , a linear transducer is placed in the radial fossa, which is known as the snuff-box. After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .
For IP-PRA , a linear transducer is placed in the standard conventional forearm radial.
After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .
Detailed description
*Ultrasound-guided catheterization of the radial artery, by proximal approach:
- Patient's hand in hyperextension with slight dorsiflexion of the wrist.
- The placement of the ultrasound probe initially linear in order to obtain the "short axis" image of the artery; then a quarter turn until obtaining a longitudinal "long axis" view.
- The operator must identify the artery using the pulsed wave Doppler;
- Insertion of the needle in the middle of the transducer providing an "in plane" orientation. Thus the needle was advanced slowly and its tip was visualized throughout the procedure. *Ultrasound-guided catheterization of the radial artery, by distal approach:
- If the right hand is along the body / if the left hand is on the trunk.
- The ultrasound probe placed at the level of the anatomical snuffbox by placing the transducer in a linear fashion then rotated coronally until a longitudinal image is obtained *In the 2 groups: - The longitudinal "in plane" approach is used - After visualization of the penetration of the bevel of the needle into the lumen of the artery and the jet of arterial blood into the syringe on aspiration, a flexible metal guide was introduced into the artery through the trocar according to the Seldinger's method. - The correct positioning of the guide in the artery was then confirmed by ultrasound. Any obstacle preventing insertion of the guide system always led to a new puncture.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP-DRA | Other | Procedure: IP-DRA vs IP- PRAIn plane distal radial artery catherterization |
| IP-PRA | Other | Procedure: IP-DRA vs IP- PRAIn plane proximal radial artery catherterization |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted in intensive care unit requiring a central venous catheter (CVC)
Key exclusion criteria (4 listed)
- Patients with radial AV shunt for hemodialysis
- Patients with Renaud phenomenon or lymphedema
- Congenital or acquired deformity of arms
- Cannulation site infection, hematoma and surgery
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 |
|---|---|---|
| IP-DRA vs IP- PRACatetherization approach in plane : distal radial artery VS proximal radial artery | Procedure or surgery | IP-DRA, IP-PRA |
Primary outcome
The overall access time
Time frame: During the cannulation procedure
Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire .
4 secondary outcomes
2. Puncture Attempts
Time frame: During the procedure
3. The guidewire time
Time frame: during the procedure
4. The access time
Time frame: during the procedure
5. Rare complications
Time frame: After 01 weeks of the 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 6 Jun 2023.
- Background: PubMed 20870991Deepika K, Palaniappan D, Fuhrman T, Saltzmanm B. Anatomic snuffbox radial artery cannulation. Anesth Analg. 2010 Oct;111(4):1078-9. doi: 10.1213/ANE.0b013e3181ef343a. No abstract available.
- Background: PubMed 24588456Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3.
- Background: PubMed 24414382Kucuk A, Yuce HH, Yalcin F, Boyaci FN, Yildiz S, Yalcin S. Forty-five degree wrist angulation is optimal for ultrasound guided long axis radial artery cannulation in patients over 60 years old: a randomized study. J Clin Monit Comput. 2014 Dec;28(6):567-72. doi: 10.1007/s10877-014-9552-z. Epub 2014 Jan 11.
- Background: PubMed 27761661Sethi S, Maitra S, Saini V, Samra T, Malhotra SK. Comparison of short-axis out-of-plane versus long-axis in-plane ultrasound-guided radial arterial cannulation in adult patients: a randomized controlled trial. J Anesth. 2017 Feb;31(1):89-94. doi: 10.1007/s00540-016-2270-6. Epub 2016 Oct 19.
- Background: PubMed 28506941Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
- Results publication: PubMed 7125255Pyles ST, Scher KS, Vega ET, Harrah JD, Rubis LJ. Cannulation of the dorsal radial artery: a new technique. Anesth Analg. 1982 Oct;61(10):876-8. No abstract available.
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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.
Mechaal Ben Ali, Professor study chair
University Tunis El Manar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP-DRA vs IP- PRA in people with Ultrasonography, run by University Tunis El Manar at 1 site in Tunisia.
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 1 inclusion and 4 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 6 Jun 2023. 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 Tunisia. 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?
The overall access time (time frame: During the cannulation 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 NCT04878887, which also lists 6 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 6 Jun 2023.