Evaluation of a Training Model for the Proficient Use of the Belmont Rapid Infuser

March 19, 2018 updated by: Children's Hospital Medical Center, Cincinnati

The Belmont Rapid Infuser is a device currently approved to replace larger volumes of necessary fluids such as blood in a fast and safe manner. The purpose of the study is to evaluate proficiency and the retention of knowledge of how to use the device based on current methods of training compared to revised training methods.

Hypotheses:

  1. The use of the traditional method of training is not effective, predicting less then half of staff will pass on the first attempt.
  2. Restructured test with hands-on training as opposed to oral presentation only with a written test will result in a pass rate of > 80%.
  3. Staff members who work in pairs will perform better than working alone when setting up the Belmont Rapid Infuser (BRI).
  4. Retention at 3 months will be higher with the restructured training method than with the traditional training method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be recruited to complete a test after undergoing either the traditional or the restructured training method. This training will be completed on one day and takes about 1 hour.

All participants who pass via either method of training are evaluated again to test retention 3-4 months later .

Study Type

Interventional

Enrollment (Actual)

56

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
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants will be recruited from the faculty, Certified Registered Nurse Anesthetists, and fellows from the Department of Anesthesia at Cincinnati Children's Hospital Medical Center.
  • They may have had educational exposure or use of the Belmont Rapid Infuser without independent assembly.

Exclusion Criteria:

  • None

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single
Staff will work alone to assemble the Belmont Rapid Infuser
Procedure: Hands on Assembly of Belmont Rapid Infuser
Participants will work individually or in pairs to assemble the Belmont Rapid Infuser in addition to completing the traditional training methods.
Experimental: Pair
Staff will work in pairs to assemble the Belmont Rapid Infuser
Procedure: Hands on Assembly of Belmont Rapid Infuser
Participants will work individually or in pairs to assemble the Belmont Rapid Infuser in addition to completing the traditional training methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proficiency
Time Frame: Measured after the training session (approximately 1 hour).
The composite score of "pass-pass" on BRI assembly and on knowledge test .
Measured after the training session (approximately 1 hour).

Secondary Outcome Measures

Outcome Measure
Time Frame
Retention of proficiency
Time Frame: 3 -4 months after delivery of the effective teaching model.
3 -4 months after delivery of the effective teaching model.

Collaborators and Investigators

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

Sponsor

Children's Hospital Medical Center, Cincinnati

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

June 1, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-1844

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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