AR for Pediatric Central Venous Catheterization

May 4, 2022 updated by: Jin-Tae Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Smart glasses
Application of smart glasses for ultrasound-guided central venous catheterization
Device: Smart glass
Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization
NO_INTERVENTION: Control
Conventional ultrasound-guided central venous catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1st success rate
Time Frame: 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
From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall success rate
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.
Overall success rate of central venous catheterization
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
Time Frame: 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
From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.
Complication
Time Frame: From end of catheterization to 24 hours after catheterization
Incidence and characteristics of complication related to central venous catheterization
From end of catheterization to 24 hours after catheterization
Satisfaction score
Time Frame: 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)
From start of catheterization to end of catheterization. Not to exceed 20 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 12, 2020

Primary Completion (ANTICIPATED)

February 28, 2023

Study Completion (ANTICIPATED)

April 30, 2023

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (ACTUAL)

May 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2003-018-1106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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