- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04283214
A Comparison of CPR Outcomes Between Traditional and Endomorphic Manikins With and Without Equipment
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58108
- North Dakota State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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