Cardiac ArrestNCT04283214
A Comparison of CPR Outcomes Between Traditional and Endomorphic Manikins With and Without Equipment
A study testing Cardiopulmonary Resuscitation in people with Cardiac Arrest, run by North Dakota State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Cardiopulmonary Resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Emergency responders employed through the ambulance stations located in North Dakota and Minnesota
- Current CPR/first-aid certification
- Active clinician, educator, or administrator.
Who cannot join
- Cardiovascular conditions inhibiting CPR performance
- Respiratory conditions inhibiting CPR performance
- Musculoskeletal conditions inhibiting CPR performance
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University
Fargo, North Dakota, 58108
About this study
Official title: 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.
- Conditions
- Cardiac Arrest
- Being tested
- Cardiopulmonary Resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary ResuscitationOther
Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins
| Study group | Role | What they receive |
|---|---|---|
| Traditional manikin | Active comparator | CPR performed on a traditional manikin Receives: Other: Cardiopulmonary Resuscitation |
| Traditional manikin with athletic equipment | Experimental | CPR performed on a traditional manikin wearing athletic equipment Receives: Other: Cardiopulmonary Resuscitation |
| Bariatric manikin | Experimental | CPR performed on a bariatric manikin Receives: Other: Cardiopulmonary Resuscitation |
| Bariatric manikin with athletic equipment | Experimental | CPR performed on a bariatric manikin wearing athletic equipment Receives: Other: Cardiopulmonary Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compression depth %
percent of time chest is compressed to adequate depth
Measured: 2 minutes
Compression rate
number of compressions per minute
Measured: 2 minutes
Chest recoil
percent of time chest fully recoils
Measured: 2 minutes
Compression depth
average depth of compressions
Measured: 2 minutes
Compression rate %
percent of time compressions are performed at an adequate rate
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Feb 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283214
- Sponsor's protocol ID
- HE20101
- Status last verified
- May 2020
- First submitted
- 2 Jan 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cardiopulmonary Resuscitation Outcomes Between Traditional and Endomorphic Manikins
- ClinicalTrials.gov ID
- NCT04283214
- Acronym / sponsor ID
- HE20101
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional manikin | Active comparator | Other: Cardiopulmonary ResuscitationCPR performed on a traditional manikin |
| Traditional manikin with athletic equipment | Experimental | Other: Cardiopulmonary ResuscitationCPR performed on a traditional manikin wearing athletic equipment |
| Bariatric manikin | Experimental | Other: Cardiopulmonary ResuscitationCPR performed on a bariatric manikin |
| Bariatric manikin with athletic equipment | Experimental | Other: Cardiopulmonary ResuscitationCPR performed on a bariatric manikin wearing athletic equipment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency responders employed through the ambulance stations located in North Dakota and Minnesota
- Current CPR/first-aid certification
- Active clinician, educator, or administrator.
Key exclusion criteria (3 listed)
- Cardiovascular conditions inhibiting CPR performance
- Respiratory conditions inhibiting CPR performance
- Musculoskeletal conditions inhibiting CPR performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary ResuscitationCardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins | Other | Bariatric manikin, Bariatric manikin with athletic equipment, Traditional manikin, Traditional manikin with athletic equipment |
Primary outcome
Compression depth %
Time frame: 2 minutes
percent of time chest is compressed to adequate depth
Compression rate
Time frame: 2 minutes
number of compressions per minute
Chest recoil
Time frame: 2 minutes
percent of time chest fully recoils
Compression depth
Time frame: 2 minutes
average depth of compressions
Compression rate %
Time frame: 2 minutes
percent of time compressions are performed at an adequate rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary Resuscitation in people with Cardiac Arrest, run by North Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression depth % (time frame: 2 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.