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Innovative Probe With Laser on Radial Artery Puncture and Catheterisation in Paediatric

NCT07454005 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2026-07-16

No results posted yet for this study

Summary

During prolonged major surgical procedures in paediatric, significant fluctuations in vital signs occur. To ensure real-time, precise monitoring of haemodynamic parameters such as blood pressure and heart rate for maintaining intraoperative safety, radial artery catheterisation remains the most conventional monitoring method for such operations. Ultrasound-guided radial artery puncture has gained increasing favour among clinicians over traditional palpation and blind techniques due to its visualisation and real-time advantages, with its benefits becoming increasingly evident. Nevertheless, this technique still carries a relatively high failure rate. This study proposes the 'laser-assisted T-shaped three-dimensional ultrasound localisation technique' for paediatric radial artery puncture and catheterisation. This aims to enhance puncture success rates, reduce the need for repeated attempts, lower complication incidence, safeguard the patient's life during surgery, and improve the quality of medical services.

Conditions

  • Radial Artery Catheterization
  • Paediatric
  • Ultrasound Guided

Interventions

DEVICE

T-shaped probe ultrasound guidance

The single-operator laser-assisted T-shaped probe consisted of TuoRen Ultrasonic System(TUR200,shenzhen Tuoren Bio-Medical Electronics Co.,LTD)with a T-shaped probe(L38T7C),a 3D-printed probe-carrying enclosure with a linear laser transmitter( ZLM120AL650-22130BXS,Shenzhen Zhonglai Technology Co.,Ltd)and ultrasonic probe manipulator.

DEVICE

Out-of-plane ultrasound guidance

Ultrasonic(Huasheng Color Ultrasonic Diagnostic System,Navi s,Shenzhen Huasheng Medical Technology Co.,LTD.)

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2026-08-01
Completion
2026-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454005 on ClinicalTrials.gov