NCT06196749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

December 25, 2023

Last Update Submit

January 19, 2024

Conditions

Coronary ArteriographyDistal Radial ArteryPercutaneous Coronary InterventionUltrasonography, Doppler

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Number of Punctures

    Immediately after the puncture procedure

  • Puncture Success Time

    Immediately after the puncture procedure

  • Distal Radial Hematoma Rate

    Immediately after the puncture and again within 24 hours

  • 24-Hour Proximal Radial Occlusion Rate

    24 hours after the procedure

  • 24-Hour Distal Radial Occlusion Rate

    24 hours after the procedure

Study Arms (2)

Modified ultrasound-guided dynamic needle tip positioning technique group

EXPERIMENTAL

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

Palpation group

ACTIVE COMPARATOR

Perform radial arterial cannulation under palpation guidance

Procedure: Palpation guided puncture

Interventions

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

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.

Modified ultrasound-guided dynamic needle tip positioning technique group
Palpation guided puncturePROCEDURE

Perform distal radial arterial cannulation under palpation guidance

Palpation group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 and 85 who agree to undergo coronaroangiography

You may not qualify if:

  • Absence of radial artery pulsatility.
  • Abnormal Allen test.
  • Hemodynamic instability.
  • Preoperative ultrasound showing a distal radial artery diameter less than 1.8mm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yupeng Liang

Zhuhai, Guangdong, 519000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 9, 2024

Study Start

July 1, 2022

Primary Completion

November 30, 2023

Study Completion

January 30, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)