Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study

Not Applicable

Active, not recruiting

• Conditions: Coronary Arteriography; Distal Radial Artery; Percutaneous Coronary Intervention; Ultrasonography, Doppler
• Interventions: Procedure: Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique; Procedure: Palpation guided puncture

• Registration Number: NCT06196749
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-11-30
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Status Verified: 2024-01
• Study First Posted: 2024-01-09
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified ultrasound-guided dynamic needle tip positioning technique group	Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique	Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique
Palpation group	Palpation guided puncture	Perform radial arterial cannulation under palpation guidance

Primary Outcome Measures

Name	Time	Method
First Needle Puncture Success Rate	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	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	Immediately after the puncture procedure	The proportion of participants who achieve successful puncture of the radial artery on their attempt

Secondary Outcome Measures

Name	Time	Method
Distal Radial Hematoma Rate	Immediately after the puncture and again within 24 hours	The proportion of participants who develop a hematoma at the puncture site on the distal radial artery.
Number of Punctures	Immediately after the puncture procedure	The total number of puncture attempts required to successfully cannulate the radial artery.
Puncture Success Time	Immediately after the puncture procedure	The duration of time elapsed from the initiation of the puncture attempt until the successful completion of the puncture.
24-Hour Proximal Radial Occlusion Rate	24 hours after the procedure	The proportion of participants who experience radial artery occlusion at the proximal site within 24 hours after the procedure.
24-Hour Distal Radial Occlusion Rate	24 hours after the procedure	The proportion of participants who experience radial artery occlusion at the distal site within 24 hours after the procedure.

Trial Locations

Locations (1)

Yupeng Liang; 🇨🇳 Zhuhai, Guangdong, China