Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Trainees

March 5, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital

The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Less Experienced Trainees: a Randomized Controlled Trial

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients by less experienced trainees. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia by less experienced trainees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

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

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 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General anesthesia
  • Arterial cannulation for hemodynamic monitoring, multiple blood sample

Exclusion Criteria:

  • Unstable vital signs, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at theradial artery

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smart Glasses
The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
Device: Smart glasses
The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
Active Comparator: Control
The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
Device: Control
The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First attempt success rate
Time Frame: During radial artery cannulation (up to 1 hour)
Success at the first skin puncture
During radial artery cannulation (up to 1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depth of radial artery
Time Frame: During radial artery cannulation (up to 1 hour)
depth of radial artery from the skin
During radial artery cannulation (up to 1 hour)
Overall attempt
Time Frame: During radial artery cannulation (up to 1 hour)
Number of attempt of radial artery cannulation
During radial artery cannulation (up to 1 hour)
Overall success rate
Time Frame: During radial artery cannulation (up to 1 hour)
Success within 2 skin puncture and within 10 minutes at the chosen radial artery
During radial artery cannulation (up to 1 hour)
Malfunction of radial artery catheter
Time Frame: After radial artery cannulation assessed during anesthesia (up to 24 hour)
Malfunction of Invasive blood pressure monitoring, Sampling
After radial artery cannulation assessed during anesthesia (up to 24 hour)
Complication rate
Time Frame: After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour)
Hematoma, Distal ischemia, Spasm accessed by ultrasound
After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour)
Operator's satisfaction
Time Frame: During radial artery cannulation (up to 1 hour)
Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)
During radial artery cannulation (up to 1 hour)
Size of radial artery
Time Frame: During radial artery cannulation (up to 1 hour)
Internal diameter of radial artery
During radial artery cannulation (up to 1 hour)
Ultrasound image time
Time Frame: During radial artery cannulation (up to 1 hour)
From ultrasound probe application, to get radial artery image on the ultrasound screen
During radial artery cannulation (up to 1 hour)
Arterial cannulation time
Time Frame: During radial artery cannulation (up to 1 hour)
From needle puncture, to Arterial waveform
During radial artery cannulation (up to 1 hour)
Overall Procedure time
Time Frame: During radial artery cannulation (up to 1 hour)
From ultrasound probe application, to Arterial waveform
During radial artery cannulation (up to 1 hour)
Operator's experience
Time Frame: During radial artery cannulation (up to 1 hour)
The prior experience of the operator's in ultrasound-guided vascular cannulation (5-10 cannulations, 10-30 cannulations, 30-50 cannulations, 50-100 cannulations)
During radial artery cannulation (up to 1 hour)

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)

September 17, 2021

Primary Completion (Actual)

February 7, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Smart Glass A-line Less Exp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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