Use of Smart Glasses for Ultrasound Guided Peripheral Venous Access

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565419
• Other study ID #: 2018-04-013
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: July 21, 2018

Study information

• Verified date: July 2018
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 21, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Catheterization
• Ultrasonography

Intervention

Device:
• Smart glasses
Participants confirm the real-time ultrasound image displayed on the viewer of smart glasses.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for successful blood aspiration	duration from application of probe to successful aspiration	up to 1 month
Secondary	first time success rate	chance for successful aspiration within 90 seconds	up to 1 month
Secondary	number of skin puncture	number of skin puncture during ultrasound guided venous access	up to 1 month
Secondary	number of needle redirection	number of needle redirection during ultrasound guided venous access	up to 1 month
Secondary	number of head movement	number of participant's head movement during ultrasound guided venous access	up to 1 month
Secondary	subjective difficulty of procedure	measuring subjective difficulty with the 100mm VAS (0: easy, 100: difficult)	up to 1 month