Training and Evaluation of Ultrasound-Guided Procedures

June 3, 2023 updated by: Clear Guide Medical
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

38 students enrolled in a course for ultrasound-guided nerve blocks will be participants in a study to evaluate the benefit of learning with ultrasound guidance. The EDU, a computer assisted guide for ultrasound interventions will be used for half the students for each of 5 nerve blocks/interventional procedures. Then the students will switch (crossover study) and perform the same interventions. Data will be recorded by dint of the tiny video cameras on the EDU and anonymized and evaluated.

Study Type

Interventional

Enrollment (Actual)

38

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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: All CRNA students in Dr. Hauglum's class on ultrasound-guided nerve blocks -

Exclusion Criteria: Any CRNA students who drop Dr. Hauglum's class on ultrasound-guided nerve blocks

-

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: learning with the EDU
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
using the EDU to perform the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance to target
Time Frame: Day 1
how close did the student come to the instructor-specified target
Day 1
number of redirects
Time Frame: Day 1
how many times did the student withdraw the needle and start again
Day 1

Collaborators and Investigators

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

Sponsor

Clear Guide Medical

Collaborators

University of Miami

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)

August 16, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

June 3, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UMiami 2021

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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