Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06196749
• Other study ID #: B2021044
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: January 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Procedure:
• Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique
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 puncture
Perform distal radial arterial cannulation under palpation guidance

Locations

Country	Name	City	State
China	Yupeng Liang	Zhuhai	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine	Health and Family Planning Commission of Guangdong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Needle Puncture Success Rate	The proportion of participants who successfully achieve a first puncture into the radial artery on their first attempt.	Immediately after the puncture procedure
Primary	Puncture success rate	The proportion of participants who achieve successful puncture of the radial artery on their attempt	Immediately after the puncture procedure
Primary	Cannulation Success Rate	The proportion of participants who successfully achieve cannulation of the radial artery after a puncture attempt.	Immediately after the cannulation procedure is completed
Secondary	Number of Punctures	The total number of puncture attempts required to successfully cannulate the radial artery.	Immediately after the puncture procedure
Secondary	Puncture Success Time	The duration of time elapsed from the initiation of the puncture attempt until the successful completion of the puncture.	Immediately after the puncture procedure
Secondary	Distal Radial Hematoma Rate	The proportion of participants who develop a hematoma at the puncture site on the distal radial artery.	Immediately after the puncture and again within 24 hours
Secondary	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.	24 hours after the procedure
Secondary	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.	24 hours after the procedure