Laser-Guided needle aims to make tiny artery sticks safer for infants
NCT ID NCT07454005
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times
Summary
This study tests a new laser-assisted ultrasound technique to help doctors place a small tube (catheter) into the wrist artery of children under 2 years old during major surgery. The goal is to see if this method improves first-attempt success and reduces complications compared to standard ultrasound. About 360 children will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 408 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 24 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhiwen Li
Changchun, Jilin, 130021, China
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