AR for Pediatric Central Venous Catheterization

Not Applicable

• Conditions: Anesthesia
• Interventions: Device: Smart glass

• Registration Number: NCT04378166
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Study Start: 2020-05-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-02-28
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart glasses	Smart glass	Application of smart glasses for ultrasound-guided central venous catheterization

Primary Outcome Measures

Name	Time	Method
1st success rate	From 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 Outcome Measures

Name	Time	Method
Elapsed time for catheterization	From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.	Overall elapsed time of central venous catheterization
Overall success rate	From 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
Complication	From end of catheterization to 24 hours after catheterization	Incidence and characteristics of complication related to central venous catheterization
Satisfaction score	From 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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of