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

Sponsor

North Dakota State University (Other)

Overall Status

Completed

CT.gov ID

NCT04283214

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

34.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: Cardiopulmonary Resuscitation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Comparison of Cardiopulmonary Resuscitation Outcomes Between Traditional and Endomorphic Manikins

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Mar 16, 2020

Actual Study Completion Date :

Mar 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional manikin CPR performed on a traditional manikin	Other: Cardiopulmonary Resuscitation 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	Other: Cardiopulmonary Resuscitation 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	Other: Cardiopulmonary Resuscitation 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	Other: Cardiopulmonary Resuscitation Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins

Outcome Measures

Primary Outcome Measures

Compression depth % [2 minutes]
percent of time chest is compressed to adequate depth
Compression rate [2 minutes]
number of compressions per minute
Chest recoil [2 minutes]
percent of time chest fully recoils
Compression depth [2 minutes]
average depth of compressions
Compression rate % [2 minutes]
percent of time compressions are performed at an adequate rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Dakota State University	Fargo	North Dakota	United States	58108

Sponsors and Collaborators

North Dakota State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

North Dakota State University

ClinicalTrials.gov Identifier:

NCT04283214

Other Study ID Numbers:

HE20101

First Posted:

Feb 25, 2020

Last Update Posted:

May 22, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Arrest

Study Results

No Results Posted as of May 22, 2020