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AR for Pediatric Central Venous Catheterization

The Usefulness of Smart-glasses During Ultrasound-guided Central Venous Catheterization in Pediatric Patients: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04378166
Enrollment
120
Registered
2020-05-07
Start date
2020-05-12
Completion date
2023-04-30
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.

Detailed description

After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study. Patients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group. Success rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared.

Interventions

DEVICESmart glass

Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

Compares central venous catheterization using smart-glasses and conventional method

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are planned to undergo surgery under general anesthesia * Patients in need for central venous catheterization during anesthesia

Exclusion criteria

* Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein * Patients with unstable vital sign prior to anesthetic induction * Patients who are not eligible for catheterization at right internal jugular vein * Refusal of legal guardian of patient

Design outcomes

Primary

MeasureTime frameDescription
1st success rateFrom start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.Success rate of central venous catheterization in first trial

Secondary

MeasureTime frameDescription
Overall success rateFrom start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.Overall success rate of central venous catheterization
Elapsed time for catheterizationFrom start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.Overall elapsed time of central venous catheterization
ComplicationFrom end of catheterization to 24 hours after catheterizationIncidence and characteristics of complication related to central venous catheterization
Satisfaction scoreFrom start of catheterization to end of catheterization. Not to exceed 20 minutes.5-points satisfaction score of practitioner (5 - Best / 4 - Good / 3 - Acceptable / 2 - Poor / 1 - Worst)

Countries

South Korea

Contacts

Primary ContactSang-Hwan Ji, M.D., M.S.
taepoongshin@gmail.com82-2-2072-3661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026