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Clinical Trials/NCT06196749
NCT06196749
Active, not recruiting
Not Applicable

Clinical Study of the Application of Modified Ultrasound-Guided Dynamic Needle Tip Positioning Technique in Percutaneous Distal Radial Artery Catheterization

Guangdong Provincial Hospital of Traditional Chinese Medicine1 site in 1 country112 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Arteriography
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Enrollment
112
Locations
1
Primary Endpoint
First Needle Puncture Success Rate
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
January 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Responsible Party
Principal Investigator
Principal Investigator

Yupeng Liang

Director

Guangdong Provincial Hospital of Traditional Chinese Medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

Secondary Outcomes

  • Distal Radial Hematoma Rate(Immediately after the puncture and again within 24 hours)
  • Number of Punctures(Immediately after the puncture procedure)
  • Puncture Success Time(Immediately after the puncture procedure)
  • 24-Hour Proximal Radial Occlusion Rate(24 hours after the procedure)
  • 24-Hour Distal Radial Occlusion Rate(24 hours after the procedure)

Study Sites (1)

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