NCT04283214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

January 2, 2020

Last Update Submit

May 21, 2020

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (5)

  • Compression depth %

    percent of time chest is compressed to adequate depth

    2 minutes

  • Compression rate

    number of compressions per minute

    2 minutes

  • Chest recoil

    percent of time chest fully recoils

    2 minutes

  • Compression depth

    average depth of compressions

    2 minutes

  • Compression rate %

    percent of time compressions are performed at an adequate rate

    2 minutes

Study Arms (4)

Traditional manikin

ACTIVE COMPARATOR

CPR performed on a traditional manikin

Other: Cardiopulmonary Resuscitation

Traditional manikin with athletic equipment

EXPERIMENTAL

CPR performed on a traditional manikin wearing athletic equipment

Other: Cardiopulmonary Resuscitation

Bariatric manikin

EXPERIMENTAL

CPR performed on a bariatric manikin

Other: Cardiopulmonary Resuscitation

Bariatric manikin with athletic equipment

EXPERIMENTAL

CPR performed on a bariatric manikin wearing athletic equipment

Other: Cardiopulmonary Resuscitation

Interventions

Cardiopulmonary ResuscitationOTHER

Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins

Bariatric manikinBariatric manikin with athletic equipmentTraditional manikinTraditional manikin with athletic equipment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58108, United States

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

February 25, 2020

Study Start

February 1, 2020

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)