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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283214
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
North Dakota State University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2020
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR

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




Primary Outcome Measures :
  1. Compression depth % [ Time Frame: 2 minutes ]
    percent of time chest is compressed to adequate depth

  2. Compression rate [ Time Frame: 2 minutes ]
    number of compressions per minute

  3. Chest recoil [ Time Frame: 2 minutes ]
    percent of time chest fully recoils

  4. Compression depth [ Time Frame: 2 minutes ]
    average depth of compressions

  5. Compression rate % [ Time Frame: 2 minutes ]
    percent of time compressions are performed at an adequate rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283214


Locations
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United States, North Dakota
North Dakota State University
Fargo, North Dakota, United States, 58108
Sponsors and Collaborators
North Dakota State University
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Responsible Party: North Dakota State University
ClinicalTrials.gov Identifier: NCT04283214    
Other Study ID Numbers: HE20101
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases