Use of Smart Glasses for Ultrasound Guided Peripheral Venous Access

July 20, 2018 updated by: Joon Min Park, Inje University

Application of Smart Glasses During Ultrasound Guided Peripheral Venous Access: a Randomized Controlled Crossover Pilot Study

Investigators aimed to explore the feasibility of smart glasses connected to a wireless ultrasound transducer for the peripheral venous access. Residents who have basic skills of ultrasound guided procedure participate in the simulation. Each participant plays the following two roles for ultrasound guided peripheral venous access; ultrasound guided peripheral venous access with and without wearing smart glasses. The order of performing two roles is determined by a randomized process and the gap between two roles are five days. The primary outcome is the time of successful blood aspiration, and secondary outcomes are first time success rate, the number of skin puncture, the number of needle redirection, the number of head movement, and subjective difficulty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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
      • Goyang-si, Korea, Republic of, 10380
        • Inje University Ilsan Paik 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Doctors who have basic skill for the ultrasound guided procedures and agree to participate the simulation

Exclusion Criteria:

  • Doctors who do not agree to participate the simulation
  • Doctors who do not have basic skill for the ultrasound guided procedures

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants conduct the ultrasound-guided peripheral cannulation while they confirm real-time images displayed on the viewer next to the phantom.
Experimental: Intervention
Participants conduct the ultrasound-guided peripheral cannulation wearing smart glasses. They confirm real-time images displayed on the viewer of smart glasses.
Device: Smart glasses
Participants confirm the real-time ultrasound image displayed on the viewer of smart glasses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time for successful blood aspiration
Time Frame: up to 1 month
duration from application of probe to successful aspiration
up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first time success rate
Time Frame: up to 1 month
chance for successful aspiration within 90 seconds
up to 1 month
number of skin puncture
Time Frame: up to 1 month
number of skin puncture during ultrasound guided venous access
up to 1 month
number of needle redirection
Time Frame: up to 1 month
number of needle redirection during ultrasound guided venous access
up to 1 month
number of head movement
Time Frame: up to 1 month
number of participant's head movement during ultrasound guided venous access
up to 1 month
subjective difficulty of procedure
Time Frame: up to 1 month
measuring subjective difficulty with the 100mm VAS (0: easy, 100: difficult)
up to 1 month

Collaborators and Investigators

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

Sponsor

Inje University

Collaborators

National Research Foundation of Korea

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)

June 20, 2018

Primary Completion (Actual)

July 19, 2018

Study Completion (Actual)

July 21, 2018

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-04-013

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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