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Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study

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Guangdong Provincial Hospital of Traditional Chinese Medicine

Status

Active, not recruiting

Conditions

Distal Radial Artery
Coronary Arteriography
Ultrasonography, Doppler
Percutaneous Coronary Intervention

Treatments

Procedure: Palpation guided puncture
Procedure: Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique

Study type

Interventional

Funder types

Other

Identifiers

NCT06196749
B2021044

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Modified ultrasound-guided dynamic needle tip positioning technique group
Experimental group
Description:
Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique
Treatment:
Procedure: Perform distal radial arterial cannulation using modified ultrasound-guided dynamic needle tip positioning technique
Palpation group
Active Comparator group
Description:
Perform radial arterial cannulation under palpation guidance
Treatment:
Procedure: Palpation guided puncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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