Radial Artery CatheterizationNCT07454005
Innovative Probe With Laser on Radial Artery Puncture and Catheterisation in Paediatric
A study testing T-shaped probe ultrasound guidance and Out-of-plane ultrasound guidance in people with Radial Artery Catheterization and Paediatric, run by The First Hospital of Jilin University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Radial Artery Catheterization, Paediatric, Ultrasound Guided
- What is being tested?
- T-shaped probe ultrasound guidance and Out-of-plane ultrasound guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radial Artery Catheterization, Paediatric, Ultrasound Guided
- Being tested
- T-shaped probe ultrasound guidance, Out-of-plane ultrasound guidance
- Keywords
- paediatric, radial artery catheterization, ultrasound guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-shaped probe ultrasound guidanceDevice
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 guidanceDevice
Ultrasonic(Huasheng Color Ultrasonic Diagnostic System,Navi s,Shenzhen Huasheng Medical Technology Co.,LTD.)
| Study group | Role | What they receive |
|---|---|---|
| T-shaped probe ultrasound guidance Group | Experimental | Not described Receives: Device: T-shaped probe ultrasound guidance |
| Out-of-plane ultrasound guidance Group | Experimental | Not described Receives: Device: Out-of-plane ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of initial catheterisation attempts without complications
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (11)
First-attempt puncture success rate
Measured: perioperative
First-attempt catheterisation success rate
Measured: perioperative
overall catheterisation success rate
Measured: 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.
Measured: perioperative
first-attempt needle tip midline positioning rate
Measured: perioperative
number of ultrasound probe repositioning attempts
Measured: perioperative
number of needle tip adjustments
Measured: perioperative
total puncture attempts
Measured: perioperative
first-attempt positioning time
Measured: perioperative
overall catheterisation completion time
Measured: perioperative
Incidence of complications within 3 days after surgery
Measured: From enrollment to 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start11 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery CatheterizationStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiwen Li, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454005
- Sponsor's protocol ID
- 2026-024
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07454005
- Acronym / sponsor ID
- 2026-024
- Conditions
- Radial Artery Catheterization, Paediatric, Ultrasound Guided
- Keywords
- paediatric, radial artery catheterization, ultrasound guided
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-shaped probe ultrasound guidance Group | Experimental | Device: T-shaped probe ultrasound guidance |
| Out-of-plane ultrasound guidance Group | Experimental | Device: Out-of-plane ultrasound guidance |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-shaped probe ultrasound guidanceThe 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 | T-shaped probe ultrasound guidance Group |
| Out-of-plane ultrasound guidanceUltrasonic(Huasheng Color Ultrasonic Diagnostic System,Navi s,Shenzhen Huasheng Medical Technology Co.,LTD.) | Device | Out-of-plane ultrasound guidance Group |
Primary outcome
Success rate of initial catheterisation attempts without complications
Time frame: From enrollment to the end of treatment at 2 weeks
11 secondary outcomes
First-attempt puncture success rate
Time frame: perioperative
First-attempt catheterisation success rate
Time frame: perioperative
overall catheterisation success rate
Time frame: perioperative
first-attempt needle tip positioning score
Time frame: perioperative
first-attempt needle tip midline positioning rate
Time frame: perioperative
number of ultrasound probe repositioning attempts
Time frame: perioperative
number of needle tip adjustments
Time frame: perioperative
total puncture attempts
Time frame: perioperative
first-attempt positioning time
Time frame: perioperative
overall catheterisation completion time
Time frame: perioperative
Incidence of complications within 3 days after surgery
Time frame: From enrollment to 3 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-shaped probe ultrasound guidance and Out-of-plane ultrasound guidance in people with Radial Artery Catheterization and Paediatric, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of initial catheterisation attempts without complications (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.