NCT06424145

Brief Summary

Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

May 1, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

May 1, 2024

Last Update Submit

June 5, 2024

Conditions

Radial Artery Injury

Keywords

Puncture site of radial arteryLidocaine injectionSuccess ratioInvasive blood pressure measurementRadial artery puncture

Outcome Measures

Primary Outcomes (1)

  • Success ratio of first radial artery puncture

    What is the probability of success the first time?

    Day 1

Secondary Outcomes (1)

  • Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes

    Day 1

Study Arms (2)

Superior group of radial artery

EXPERIMENTAL

Injection of 1% lidocaine 1 ml above the artery

Diagnostic Test: Superior radial artery

Right radial artery group

EXPERIMENTAL

Injection of 1% lidocaine 1 ml to the right side of the artery

Diagnostic Test: Right side of radial artery

Interventions

Superior radial arteryDIAGNOSTIC_TEST

Upper radial artery, 1 ml of lidocaine

Superior group of radial artery
Right side of radial arteryDIAGNOSTIC_TEST

Right side of the radial artery,1ml of lidocaine

Right radial artery group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Class I-III, patients aged 18-80 years
  • Planned surgery with radial artery catheterization
  • Allen test negative
  • Sign the informed consent form and voluntarily participate in this trial

You may not qualify if:

  • Inflamed skin at puncture site
  • Extremely nervous and unable to cooperate
  • Ultrasonographic assessment of aberrant radial artery
  • Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
  • The patient had undergone radial artery catheterization in the same arm in the past week
  • History of hypersensitivity to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan provincial Peopel'Hospital

Chengdu, Sichuan, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 21, 2024

Study Start

June 30, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

June 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)