Clinical trial NCT06196749: Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study
Official title: Clinical Study of the Application of Modified Ultrasound-Guided Dynamic Needle Tip Positioning Technique in Percutaneous Distal Radial Artery Catheterization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Arteriography
Distal Radial Artery
Percutaneous Coronary Intervention
Ultrasonography, Doppler
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Health and Family Planning Commission of Guangdong
First posted: 2024-01-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Patients between the ages of 18 and 85 who agree to undergo coronaroangiography

Exclusion Criteria:

1. Absence of radial artery pulsatility.
2. Abnormal Allen test.
3. Hemodynamic instability.
4. Preoperative ultrasound showing a distal radial artery diameter less than 1.8mm.

Primary outcomes:
measure: First Needle Puncture Success Rate
timeFrame: Immediately after the puncture procedure
measure: Puncture success rate
timeFrame: Immediately after the puncture procedure
measure: Cannulation Success Rate
timeFrame: Immediately after the cannulation procedure is completed
Secondary outcomes:
measure: Number of Punctures
timeFrame: Immediately after the puncture procedure
measure: Puncture Success Time
timeFrame: Immediately after the puncture procedure
measure: Distal Radial Hematoma Rate
timeFrame: Immediately after the puncture and again within 24 hours
measure: 24-Hour Proximal Radial Occlusion Rate
timeFrame: 24 hours after the procedure
measure: 24-Hour Distal Radial Occlusion Rate
timeFrame: 24 hours after the procedure
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Yupeng Liang
state: Guangdong
Study officials:
References: