A Comparison of CPR Outcomes Between Traditional and Endomorphic Manikins With and Without Equipment

May 21, 2020 updated by: North Dakota State University

A Comparison of Cardiopulmonary Resuscitation Outcomes Between Traditional and Endomorphic Manikins

The study's research design is a randomized experiment. 50 emergency responders (emergency medical responders, emergency medical technicians, advanced emergency medical technicians, and paramedics) will be recruited for this research. All data collection will take place in Lab 14 of the Benson Bunker Fieldhouse or a professional, confidential location of the participant's choosing.

Prior to CPR performance, participants will be given an informed consent form to sign. The form will be explained in detail by the researcher collecting data. After obtaining informed consent, participants will be asked to fill out a demographic questionnaire to collect information such as age, gender, years of emergency responder experience/employment, and years of CPR certification. Demographic information provided by participants will be utilized in data analysis. The demographics form should take approximately five minutes to complete. Participants will be randomly assigned to the four trials they will partake in and instructed via oral script (one for over and one for under football shoulder pads) to perform four-trials total of three-minute single-rescuer CPR on both a traditional CPR manikin and "Fat Old Fred" (bariatric) CPR manikin. CPR must be performed in accordance with the American Heart Association's 2015 CPR Guidelines and participants will use a CPRmeter 2 device to collect data to determine the quality of CPR components (chest compression depth/recoil, compression rate, CPR compression duration, mean depth, mean rate, and total number of compressions). The entire study session should take 25 to 30 minutes to complete.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

50

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

    • North Dakota
      • Fargo, North Dakota, United States, 58108
        • North Dakota State University

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergency responders employed through the ambulance stations located in North Dakota and Minnesota
  • Current CPR/first-aid certification
  • Active clinician, educator, or administrator.

Exclusion Criteria:

  • Cardiovascular conditions inhibiting CPR performance
  • Respiratory conditions inhibiting CPR performance
  • Musculoskeletal conditions inhibiting CPR performance

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional manikin
CPR performed on a traditional manikin
Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins
Experimental: Traditional manikin with athletic equipment
CPR performed on a traditional manikin wearing athletic equipment
Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins
Experimental: Bariatric manikin
CPR performed on a bariatric manikin
Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins
Experimental: Bariatric manikin with athletic equipment
CPR performed on a bariatric manikin wearing athletic equipment
Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compression depth %
Time Frame: 2 minutes
percent of time chest is compressed to adequate depth
2 minutes
Compression rate
Time Frame: 2 minutes
number of compressions per minute
2 minutes
Chest recoil
Time Frame: 2 minutes
percent of time chest fully recoils
2 minutes
Compression depth
Time Frame: 2 minutes
average depth of compressions
2 minutes
Compression rate %
Time Frame: 2 minutes
percent of time compressions are performed at an adequate rate
2 minutes

Collaborators and Investigators

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

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)

February 1, 2020

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

March 16, 2020

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE20101

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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