Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Percutaneous Coronary Intervention; Distal Radial Artery; Ultrasonography, Doppler; Coronary Arteriography
• Intervention / Treatment: Procedure: Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique; Procedure: Palpation guided puncture

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Yupeng Liang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified ultrasound-guided dynamic needle tip positioning technique group; Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique	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.
Active Comparator: Palpation group; Perform radial arterial cannulation under palpation guidance	Procedure: Palpation guided puncture; Perform distal radial arterial cannulation under palpation guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Puncture success rate	The proportion of participants who achieve successful puncture of the radial artery on their attempt	Immediately after the puncture procedure
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Punctures	The total number of puncture attempts required to successfully cannulate the radial artery.	Immediately after the puncture procedure
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
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
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
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Collaborators: Health and Family Planning Commission of Guangdong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: B2021044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No