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Enrolling By Invitation
NCT07454005
Innovative Probe With Laser on Radial Artery Puncture and Catheterisation in Paediatric
Conditions: Radial Artery Catheterization, Paediatric, Ultrasound Guided
Sex: All
Ages: 1 Day – 24 Months
Healthy volunteers: No
Phase: NA
Enrollment: 408
Sponsor: The First Hospital of Jilin University
Location: Zhiwen Li Changchun Jilin
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07454005). StuddyBuddy aggregates publicly available trial information.