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

NCT07454005 · tracked via the Priya Life Science China tracker

Sponsor

The First Hospital of Jilin University

Phase

Not applicable

Started

2026-02-11

Last updated

2026-09-21

Condition(s) studied

Radial Artery CatheterizationPaediatricUltrasound Guided

Investigational drug(s) / intervention(s)

T-shaped probe ultrasound guidanceOut-of-plane ultrasound guidance

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.

Out-of-plane ultrasound guidance: Ultrasonic(Huasheng Color Ultrasonic Diagnostic System,Navi s,Shenzhen Huasheng Medical Technology Co.,LTD.)

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.

Eligibility

Sex

ALL

Min age

1 Day

Max age

24 Months

Healthy volunteers

Inclusion Criteria: * The paediatric patient's family fully understands and voluntarily participates in this study, having signed the informed consent form. * Paediatric patients undergoing critical surgery requiring radial artery puncture and catheterisation for continuous blood pressure monitoring are selected. * ASA physical status classification of I-IV. * Age ≤ 24 months, gender not restricted. Exclusion Criteria: * Paediatric patients who have undergone radial artery puncture within the past month. * Paediatric patients with abnormal development of the radial or ulnar arteries, peripheral vascular disease at the radial puncture site, congenital heart disease, or haemorrhagic or cardiogenic shock. * Paediatric patients with wounds, infections, or haematomas near the radial puncture site. * Ultrasound imaging demonstrating inadequate collateral circulation or a negative Allen test. * Cases where the paediatric patient's guardian refuses to sign the informed consent form for study participation. * Other circumstances deemed unsuitable for trial participation by the investigator.

Primary outcome measure(s)

Success rate of initial catheterisation attempts without complications — From enrollment to the end of treatment at 2 weeks

Trial sites (1)

Facility	City	Region	Status
Zhiwen Li	Changchun	Jilin

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07454005 on ClinicalTrials.gov ↗ ← All trials in China