Use of Smart Glasses for Ultrasound Guided Peripheral Venous Access

Sponsor

Inje University (Other)

Overall Status

Completed

CT.gov ID

NCT03565419

Collaborator

National Research Foundation of Korea (Other)

Enrollment

Location

Arms

Actual Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasonography Catheterization	Device: Smart glasses	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Jun 20, 2018

Actual Primary Completion Date :

Jul 19, 2018

Actual Study Completion Date :

Jul 21, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

time for successful blood aspiration [up to 1 month]
duration from application of probe to successful aspiration

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Ilsan Paik Hospital	Goyang-si		Korea, Republic of	10380

Sponsors and Collaborators

Inje University
National Research Foundation of Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joon Min Park, Associate professor, Department of Emergency Medicine, Inje University

ClinicalTrials.gov Identifier:

NCT03565419

Other Study ID Numbers:

2018-04-013

First Posted:

Jun 21, 2018

Last Update Posted:

Jul 24, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 24, 2018