Radial Artery InjuryNCT06424145
Effect of Local Anesthesia Position of Lidocaine Injection on the Success Rate of Radial Artery Puncture Tube
A study testing Superior radial artery and Right side of radial artery in people with Radial Artery Injury, run by Ting Xu at 1 site in China.
Trial summary
Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radial Artery Injury
- What is being tested?
- Superior radial artery and Right side of radial artery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 1 Jan 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Class I-III, patients aged 18-80 years
- Planned surgery with radial artery catheterization
- Allen test negative
- Sign the informed consent form and voluntarily participate in this trial
Who cannot join
- Inflamed skin at puncture site
- Extremely nervous and unable to cooperate
- Ultrasonographic assessment of aberrant radial artery
- Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
- The patient had undergone radial artery catheterization in the same arm in the past week
- History of hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized and Controlled Clinical Research Projects
Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.
Read the detailed description
Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.
- Conditions
- Radial Artery Injury
- Being tested
- Superior radial artery, Right side of radial artery
- Keywords
- Puncture site of radial artery, Lidocaine injection, Success ratio, Invasive blood pressure measurement, Radial artery puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior radial arteryDiagnostic test
Upper radial artery, 1 ml of lidocaine
Right side of radial arteryDiagnostic test
Right side of the radial artery,1ml of lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Superior group of radial artery | Experimental | Injection of 1% lidocaine 1 ml above the artery Receives: Diagnostic Test: Superior radial artery |
| Right radial artery group | Experimental | Injection of 1% lidocaine 1 ml to the right side of the artery Receives: Diagnostic Test: Right side of radial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success ratio of first radial artery puncture
What is the probability of success the first time?
Measured: Day 1
Secondary outcomes (1)
Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes
In millimeters, Increase or decrease
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery InjuryStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ting Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting Xu, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424145
- Sponsor's protocol ID
- 19981228
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 6 Jun 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized and Controlled Clinical Research Projects
- ClinicalTrials.gov ID
- NCT06424145
- Acronym / sponsor ID
- 19981228
- Conditions
- Radial Artery Injury
- Keywords
- Puncture site of radial artery, Lidocaine injection, Success ratio, Invasive blood pressure measurement, Radial artery puncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Ting XuUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 May 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.
Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.
Detailed description
Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior group of radial artery | Experimental | Diagnostic Test: Superior radial arteryInjection of 1% lidocaine 1 ml above the artery |
| Right radial artery group | Experimental | Diagnostic Test: Right side of radial arteryInjection of 1% lidocaine 1 ml to the right side of the artery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA Class I-III, patients aged 18-80 years
- Planned surgery with radial artery catheterization
- Allen test negative
- Sign the informed consent form and voluntarily participate in this trial
Key exclusion criteria (6 listed)
- Inflamed skin at puncture site
- Extremely nervous and unable to cooperate
- Ultrasonographic assessment of aberrant radial artery
- Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
- The patient had undergone radial artery catheterization in the same arm in the past week
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 |
|---|---|---|
| Superior radial arteryUpper radial artery, 1 ml of lidocaine | Diagnostic test | Superior group of radial artery |
| Right side of radial arteryRight side of the radial artery,1ml of lidocaine | Diagnostic test | Right radial artery group |
Primary outcome
Success ratio of first radial artery puncture
Time frame: Day 1
What is the probability of success the first time?
1 secondary outcome
Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Radial Artery Injury
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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 Superior radial artery and Right side of radial artery in people with Radial Artery Injury, run by Ting Xu 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 4 inclusion and 6 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 6 Jun 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?
Success ratio of first radial artery puncture (time frame: Day 1). 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 6 Jun 2024.