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

Out-of-plane Versus Real-time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Radial Artery Puncture and Catheterisation in Paediatric: A Randomised Clinical Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ultrasound Guided; Paediatric; Radial Artery Catheterization
• Intervention / Treatment: Device: T-shaped probe ultrasound guidance; Device: Out-of-plane ultrasound guidance

Detailed Description

Following induction of anaesthesia in the paediatric patient, position one arm in slight abduction with a thin rolled bandage placed beneath the wrist to maintain mild dorsal extension. Disinfect the radial artery puncture site with povidone-iodine solution and drape the area. Select the appropriate ultrasound system and probe according to the assigned group (T-shape ultrasound guidance group or out-of-plane ultrasound guidance group).

T-shaped probe ultrasound guidance Group:

Fit the 3D-printed housing, which contains a laser emitter, onto the T-shaped ultrasound probe. The laser emitter is positioned directly above the mark on the short-axis plane of the T-shaped ultrasound probe. Instruct the assistant to apply an appropriate amount of coupling gel evenly to the ultrasound probe. Working in conjunction with the assistant, the operator should cover the entire assembly-comprising the 3D-printed, three-axis adjustable support arm and the ultrasound probe-with a sterile sleeve, expel any air from between the probe and the sleeve, and apply sterile coupling gel evenly to the outer surface of the sleeve where it will come into contact with the child's skin to complete the preparation of the equipment. To begin positioning, the operator uses the support arm to gently place the T-shaped ultrasound probe 0.5 cm below the child's wrist crease, with the short axis at the distal end and the long axis at the proximal end. The support arm and rotation axis are adjusted so that the midline of the short-axis ultrasound image passes through the centre of the radial artery's cross-section. Subsequently, with the short axis as the centre, the long axis is swivelled in a fan-shaped pattern from side to side to achieve optimal visualisation of the radial artery in the long-axis ultrasound image. At this point, the laser beam is directed towards the superficial projection of the target radial artery beneath the ultrasound probe. Once the support arm has been adjusted to ensure the probe rests stably against the skin surface, a stable, fully visualised ultrasound-guided procedure is established that can be performed by a single operator using both hands. The operator holds the ultrasound probe steady with their left hand, whilst holding a 24G arterial puncture cannula in their right hand, ensuring the laser fully covers the needle shaft and inserting the needle at an angle of approximately 30° to the skin (the insertion point is 0.5 cm from the ultrasound probe). Once the needle tip has entered the subcutaneous tissue, if deviation is observed on the short-axis ultrasound image, the angle of insertion may be adjusted, with the number of adjustments recorded. The needle should penetrate the anterior wall directly above the radial artery; whilst the right hand maintains the position of the cannula, the left hand slides the probe towards the proximal end and, using the short-axis image, determines the position of the needle tip prior to cannula insertion according to the 'dynamic needle tip method'. A screenshot is retained for scoring the needle tip position on the first attempt. Upon observing backflow, move the ultrasound probe distally along the course of the artery by approximately 0.5 cm; once the needle is shown to have entered the vessel in the long-axis view, advance the needle at an appropriate angle under ultrasound guidance. When the position is satisfactory, withdraw the needle core; if backflow is unobstructed, insert the introducer sheath. If resistance persists, the operator shall decide, based on clinical experience, whether to employ the penetration technique. If insertion fails, withdraw the needle from the radial artery and apply pressure to the puncture site with sterile gauze. After approximately 3 minutes, when there is no significant bleeding at the puncture site, proceed to the next attempt. During this time, the procedure timer shall not be paused, and the number of times the ultrasound probe is repositioned and the needle tip is adjusted shall be recorded throughout the procedure.

Out-of-plane ultrasound guidance Group:

The assistant applies coupling gel to the surface of the ultrasound probe. Working together, the operator and assistant cover the probe with a sterile sleeve, expel any air from between the probe and the sleeve, and evenly apply sterile coupling gel to the outer surface of the sleeve where it will come into contact with the child's skin, thereby completing the preparation of the equipment. To begin positioning, the operator gently places the ultrasound probe 1 cm below the child's wrist crease, ensuring that the short-axis midline of the ultrasound image passes through the radial artery at the centre of the image. The left hand stabilises the ultrasound probe, and positioning is complete. Adjust the ultrasound probe to form an angle of approximately 90° with the skin. Once the midpoint of the probe's short-axis plane aligns with the marked point, insert the 24G arterial puncture cannula with the right hand at an angle of approximately 30° to the skin. Upon observing blood return, capture a screenshot to score the needle tip position for the first attempt. Use the 'dynamic needle tip method' to guide the advancement of the puncture needle. Once the position is correct, withdraw the needle core; if blood return is unobstructed, insert the cannula. If resistance persists, the operator shall decide, based on their experience, whether to use the penetration technique. If insertion fails, withdraw the needle from the radial artery and apply pressure to the puncture site with sterile gauze. After approximately 3 minutes, when there is no significant bleeding at the puncture site, proceed to the next attempt. During this time, the operation timer shall not be paused, and the number of times the ultrasound probe is repositioned and the number of needle tip adjustments shall be recorded throughout the procedure.

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Zhiwen Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-shaped probe ultrasound guidance Group	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.
Experimental: Out-of-plane ultrasound guidance Group	Device: Out-of-plane ultrasound guidance; Ultrasonic(Huasheng Color Ultrasonic Diagnostic System,Navi s,Shenzhen Huasheng Medical Technology Co.,LTD.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of initial catheterisation attempts without complications	From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt puncture success rate		perioperative
First-attempt catheterisation success rate		perioperative
overall catheterisation success rate		perioperative
first-attempt needle tip positioning score	Divide the cross-section of the internal jugular vein into 12 quadrants, assigning each quadrant a score based on its position within the quadrant, ranging from a minimum of 1 point to a maximum of 5 points.The Higher the score,the closer it is to the midpoint of the cross-section.	perioperative
first-attempt needle tip midline positioning rate		perioperative
number of ultrasound probe repositioning attempts		perioperative
number of needle tip adjustments		perioperative
total puncture attempts		perioperative
first-attempt positioning time		perioperative
overall catheterisation completion time		perioperative
Incidence of complications within 3 days after surgery		From enrollment to 3 days after surgery

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radial artery catheterization; paediatric; ultrasound guided
• Other Study ID Numbers: 2026-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No