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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiopulmonary Resuscitation
Sponsored by
North Dakota State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North Dakota State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Traditional manikin

Traditional manikin with athletic equipment

Bariatric manikin

Bariatric manikin with athletic equipment

Arm Description

CPR performed on a traditional manikin

CPR performed on a traditional manikin wearing athletic equipment

CPR performed on a bariatric manikin

CPR performed on a bariatric manikin wearing athletic equipment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 2, 2020
Last Updated
May 21, 2020
Sponsor
North Dakota State University
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1. Study Identification

Unique Protocol Identification Number
NCT04283214
Brief Title
A Comparison of CPR Outcomes Between Traditional and Endomorphic Manikins With and Without Equipment
Official Title
A Comparison of Cardiopulmonary Resuscitation Outcomes Between Traditional and Endomorphic Manikins
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Dakota State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional manikin
Arm Type
Active Comparator
Arm Description
CPR performed on a traditional manikin
Arm Title
Traditional manikin with athletic equipment
Arm Type
Experimental
Arm Description
CPR performed on a traditional manikin wearing athletic equipment
Arm Title
Bariatric manikin
Arm Type
Experimental
Arm Description
CPR performed on a bariatric manikin
Arm Title
Bariatric manikin with athletic equipment
Arm Type
Experimental
Arm Description
CPR performed on a bariatric manikin wearing athletic equipment
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary Resuscitation
Intervention Description
Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins
Primary Outcome Measure Information:
Title
Compression depth %
Description
percent of time chest is compressed to adequate depth
Time Frame
2 minutes
Title
Compression rate
Description
number of compressions per minute
Time Frame
2 minutes
Title
Chest recoil
Description
percent of time chest fully recoils
Time Frame
2 minutes
Title
Compression depth
Description
average depth of compressions
Time Frame
2 minutes
Title
Compression rate %
Description
percent of time compressions are performed at an adequate rate
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
North Dakota State University
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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