Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study

NCT ID: NCT06196749

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-01-30

Brief Summary

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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

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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.

Conditions

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Coronary Arteriography Distal Radial Artery Percutaneous Coronary Intervention Ultrasonography, Doppler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Modified ultrasound-guided dynamic needle tip positioning technique group

Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique

Group Type EXPERIMENTAL

Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique

Intervention Type PROCEDURE

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 group

Perform radial arterial cannulation under palpation guidance

Group Type ACTIVE_COMPARATOR

Palpation guided puncture

Intervention Type PROCEDURE

Perform distal radial arterial cannulation under palpation guidance

Interventions

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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.

Intervention Type PROCEDURE

Palpation guided puncture

Perform distal radial arterial cannulation under palpation guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health and Family Planning Commission of Guangdong

OTHER_GOV

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yupeng Liang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yupeng Liang

Zhuhai, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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B2021044

Identifier Type: -

Identifier Source: org_study_id

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