AR for Pediatric Central Venous Catheterization

Seoul National University Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

120

Conditions

Anesthesia

Interventions

Smart glassDEVICE

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

Eligibility

Sex: ALLMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

1st success rate

Success rate of central venous catheterization in first trial

Time frame: From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.

Secondary Outcomes

Overall success rate

Overall success rate of central venous catheterization

Time frame: From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.

Elapsed time for catheterization

Overall elapsed time of central venous catheterization

Time frame: From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.

Complication

Incidence and characteristics of complication related to central venous catheterization

Time frame: From end of catheterization to 24 hours after catheterization

Satisfaction score

5-points satisfaction score of practitioner (5 - Best / 4 - Good / 3 - Acceptable / 2 - Poor / 1 - Worst)

Time frame: From start of catheterization to end of catheterization. Not to exceed 20 minutes.

Central Contacts

Sang-Hwan Ji, M.D., M.S.

CONTACT

82-2-2072-3661 taepoongshin@gmail.com

Data from ClinicalTrials.gov

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