Coronary ArteriographyNCT06196749
Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study
A study testing Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique and Palpation guided puncture in people with Coronary Arteriography and Distal Radial Artery, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The research project is focused on examining the clinical effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Arteriography, Distal Radial Artery, Percutaneous Coronary Intervention
- What is being tested?
- Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique and Palpation guided puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jan 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 85 who agree to undergo coronaroangiography
Who cannot join
- Absence of radial artery pulsatility.
- Abnormal Allen test.
- Hemodynamic instability.
- Preoperative ultrasound showing a distal radial artery diameter less than 1.8mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of the Application of Modified Ultrasound-Guided Dynamic Needle Tip Positioning Technique in Percutaneous Distal Radial Artery Catheterization
The research project is focused on examining the clinical effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization. Anticipated results suggest that the improved ultrasound dynamic needle tip positioning method will surpass tactile guidance in terms of the success rate of the first puncture attempt, as well as overall puncture and catheterization success rates.
Read the detailed description
The distal radial artery access route has several advantages; however, it comes with drawbacks like tortuous anatomy and a smaller lumen diameter. Compared to the wrist radial artery approach, it is more prone to spasm and has a lower success rate for puncture and catheterization. This clinical study aims to explore the effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization.
In this prospective, randomized, single-center study, we will enroll 112 patients scheduled for percutaneous coronary angiography. They will be randomly assigned to either the control group (56 cases) or the study group (56 cases) using digital odd-even randomization. The control group will undergo conventional tactile guidance, while the study group will be guided by the improved ultrasound dynamic needle tip positioning method.
Parameters to be compared between the two groups include the success rate of the first puncture attempt, overall puncture success rate, number of puncture attempts, success rate of catheterization, time to successful catheterization, proportion of sheath sizes used, incidence of hematoma, and incidence of radial artery occlusion 24 hours post-procedure. The anticipated outcome is that the improved ultrasound dynamic needle tip positioning method will enhance the success rate of the first puncture attempt, overall puncture success rate, and catheterization success rate, while reducing the number of puncture attempts and operation time.
- Conditions
- Coronary Arteriography, Distal Radial Artery, Percutaneous Coronary Intervention, Ultrasonography, Doppler
- Being tested
- Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique, Palpation guided puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning techniqueProcedure or surgery
This study employs a modified ultrasound-guided dynamic needle tip positioning technique for distal radial arterial cannulation. The technique uses an ultrasound probe with two wires to create an acoustic shadow, improving needle tip visibility. Real-time dynamic tracking assists in precise needle placement within the distal radial artery through the nose-horn region. This method is used for coronary angiography and potential percutaneous coronary interventions, aiming to increase success rates and reduce complications like hematoma, nerve injury, and arterial spasm, thus enhancing safety and efficiency.
Palpation guided punctureProcedure or surgery
Perform distal radial arterial cannulation under palpation guidance
| Study group | Role | What they receive |
|---|---|---|
| Modified ultrasound-guided dynamic needle tip positioning technique group | Experimental | Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique Receives: Procedure: Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique |
| Palpation group | Active comparator | Perform radial arterial cannulation under palpation guidance Receives: Procedure: Palpation guided puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Needle Puncture Success Rate
The proportion of participants who successfully achieve a first puncture into the radial artery on their first attempt.
Measured: Immediately after the puncture procedure
Puncture success rate
The proportion of participants who achieve successful puncture of the radial artery on their attempt
Measured: Immediately after the puncture procedure
Cannulation Success Rate
The proportion of participants who successfully achieve cannulation of the radial artery after a puncture attempt.
Measured: Immediately after the cannulation procedure is completed
Secondary outcomes (5)
Number of Punctures
The total number of puncture attempts required to successfully cannulate the radial artery.
Measured: Immediately after the puncture procedure
Puncture Success Time
The duration of time elapsed from the initiation of the puncture attempt until the successful completion of the puncture.
Measured: Immediately after the puncture procedure
Distal Radial Hematoma Rate
The proportion of participants who develop a hematoma at the puncture site on the distal radial artery.
Measured: Immediately after the puncture and again within 24 hours
24-Hour Proximal Radial Occlusion Rate
The proportion of participants who experience radial artery occlusion at the proximal site within 24 hours after the procedure.
Measured: 24 hours after the procedure
24-Hour Distal Radial Occlusion Rate
The proportion of participants who experience radial artery occlusion at the distal site within 24 hours after the procedure.
Measured: 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jul 2022
- Primary completion30 Nov 2023
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriographyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Family Planning Commission of Guangdong
- Responsible party
- Principal investigator, Yupeng Liang, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196749
- Sponsor's protocol ID
- B2021044
- Status last verified
- Jan 2024
- First submitted
- 25 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Application of Modified Ultrasound-Guided Dynamic Needle Tip Positioning Technique in Percutaneous Distal Radial Artery Catheterization
- ClinicalTrials.gov ID
- NCT06196749
- Acronym / sponsor ID
- B2021044
- Conditions
- Coronary Arteriography, Distal Radial Artery, Percutaneous Coronary Intervention, Ultrasonography, Doppler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Health and Family Planning Commission of Guangdong
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 9 Jan 2024 (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.
The research project is focused on examining the clinical effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization. Anticipated results suggest that the improved ultrasound dynamic needle tip positioning method will surpass tactile guidance in terms of the success rate of the first puncture attempt, as well as overall puncture and catheterization success rates.
Detailed description
The distal radial artery access route has several advantages; however, it comes with drawbacks like tortuous anatomy and a smaller lumen diameter. Compared to the wrist radial artery approach, it is more prone to spasm and has a lower success rate for puncture and catheterization. This clinical study aims to explore the effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization.
In this prospective, randomized, single-center study, we will enroll 112 patients scheduled for percutaneous coronary angiography. They will be randomly assigned to either the control group (56 cases) or the study group (56 cases) using digital odd-even randomization. The control group will undergo conventional tactile guidance, while the study group will be guided by the improved ultrasound dynamic needle tip positioning method.
Parameters to be compared between the two groups include the success rate of the first puncture attempt, overall puncture success rate, number of puncture attempts, success rate of catheterization, time to successful catheterization, proportion of sheath sizes used, incidence of hematoma, and incidence of radial artery occlusion 24 hours post-procedure. The anticipated outcome is that the improved ultrasound dynamic needle tip positioning method will enhance the success rate of the first puncture attempt, overall puncture success rate, and catheterization success rate, while reducing the number of puncture attempts and operation time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ultrasound-guided dynamic needle tip positioning technique group | Experimental | Procedure: Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning techniquePerform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique |
| Palpation group | Active comparator | Procedure: Palpation guided puncturePerform radial arterial cannulation under palpation guidance |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18 and 85 who agree to undergo coronaroangiography
Key exclusion criteria (4 listed)
- Absence of radial artery pulsatility.
- Abnormal Allen test.
- Hemodynamic instability.
- Preoperative ultrasound showing a distal radial artery diameter less than 1.8mm.
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 |
|---|---|---|
| Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning techniqueThis study employs a modified ultrasound-guided dynamic needle tip positioning technique for distal radial arterial cannulation. The technique uses an ultrasound probe with two wires to create an acoustic shadow, improving needle tip visibility. Real-time dynamic tracking assists in precise needle placement within the distal radial artery through the nose-horn region. This method is used for coronary angiography and potential percutaneous coronary interventions, aiming to increase success rates and reduce complications like hematoma, nerve injury, and arterial spasm, thus enhancing safety and efficiency. | Procedure or surgery | Modified ultrasound-guided dynamic needle tip positioning technique group |
| Palpation guided puncturePerform distal radial arterial cannulation under palpation guidance | Procedure or surgery | Palpation group |
Primary outcome
First Needle Puncture Success Rate
Time frame: Immediately after the puncture procedure
The proportion of participants who successfully achieve a first puncture into the radial artery on their first attempt.
Puncture success rate
Time frame: Immediately after the puncture procedure
The proportion of participants who achieve successful puncture of the radial artery on their attempt
Cannulation Success Rate
Time frame: Immediately after the cannulation procedure is completed
The proportion of participants who successfully achieve cannulation of the radial artery after a puncture attempt.
5 secondary outcomes
Number of Punctures
Time frame: Immediately after the puncture procedure
Puncture Success Time
Time frame: Immediately after the puncture procedure
Distal Radial Hematoma Rate
Time frame: Immediately after the puncture and again within 24 hours
24-Hour Proximal Radial Occlusion Rate
Time frame: 24 hours after the procedure
24-Hour Distal Radial Occlusion Rate
Time frame: 24 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique and Palpation guided puncture in people with Coronary Arteriography and Distal Radial Artery, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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 China. 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?
Results are not available in the source record.
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?
First Needle Puncture Success Rate (time frame: Immediately after the puncture procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.