NCT03565419

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

29 days

First QC Date

May 4, 2018

Last Update Submit

July 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • time for successful blood aspiration

    duration from application of probe to successful aspiration

    up to 1 month

Secondary Outcomes (5)

  • first time success rate

    up to 1 month

  • number of skin puncture

    up to 1 month

  • number of needle redirection

    up to 1 month

  • number of head movement

    up to 1 month

  • subjective difficulty of procedure

    up to 1 month

Study Arms (2)

Control

NO INTERVENTION

Participants conduct the ultrasound-guided peripheral cannulation while they confirm real-time images displayed on the viewer next to the phantom.

Intervention

EXPERIMENTAL

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

Interventions

Participants confirm the real-time ultrasound image displayed on the viewer of smart glasses.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Ilsan Paik Hospital

Goyang-si, 10380, South Korea

Location

MeSH Terms

Interventions

Smart Glasses

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of Emergency Medicine

Study Record Dates

First Submitted

May 4, 2018

First Posted

June 21, 2018

Study Start

June 20, 2018

Primary Completion

July 19, 2018

Study Completion

July 21, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations