NCT05889923

Brief Summary

38 certified registered nurse anesthetist (CRNA) students will learn 5 different ultrasound-guided regional anesthesia blocks both with and without a novel device, the EDU which gives the student help finding the right needle path.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

May 24, 2023

Last Update Submit

June 3, 2023

Conditions

Learning Anesthesia Procedures

Outcome Measures

Primary Outcomes (2)

  • Distance to target

    how close did the student come to the instructor-specified target

    Day 1

  • number of redirects

    how many times did the student withdraw the needle and start again

    Day 1

Study Arms (1)

learning with the EDU

EXPERIMENTAL

Students will perform 5 ultrasound-guided regional anesthesia procedures on a phantom using the EDU which shows the student how to hold the needle and probe to hit the target.

Device: With EDU

Interventions

With EDUDEVICE

using the EDU to perform the procedure

learning with the EDU

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

August 16, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)