- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03953105
Electronic Pediatric Emergency Ruler vs the Broselow Tape. (ePERvsBT)
Electronic Pediatric Emergency Ruler vs the Broselow Tape in a Simulated Pediatric Emergency Scenario
Comparison of two different pediatric emergency rulers for length-based body weight estimation in pediatric emergencies.
Primary outcome is the time needed to identify four defined parameters from the pediatric emergency rulers during a low-fidelity pediatric emergency scenario (cardiac arrest). Secondary outcome is the correctness of the identified parameters and the percentage deviation from the correct value.
Study Overview
Status
Intervention / Treatment
Detailed Description
Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich Switzerland were asked to participate in this study. If they were not familiar with one of the three devices written informed consent was obtained and the participant included in this study. This exclusion criteria was necessary to prevent a bias by already knowing where to find the information of interest.
The pediatric emergency rulers investigated were the electronic Pediatric Emergency Ruler (ePER) and the Broselow Tape (BT)
All participants were instructed for the use of the two pediatric emergency rulers and were given time to practice with each device using one training manikin (Sim-Baby)
After they felt comfortable using the devices the participants were randomly assigned to use each device only once with one of two different manikins:
Resusci Baby, Laerdal/Dräger Medical Switzerland AG, Liebefeld, Switzerland Ambu® Junior, Ambu® GmbH, Bad Nauheim, Germany
Each manikin was only used once for the same participant. This guaranteed that the participants were blinded for the manikins.
The low-fidelity pediatric emergency scenario simulated was a cardiac arrest and the participants were asked to identify the following information from the pediatric emergency rulers:
Estimated body weight Joule suggested for defibrillation Recommended epinephrine dose Suggested endotracheal tube size
Participants stood aside from the manikin with a pediatric emergency ruler in their hand. After they stated they were ready, the facilitator started a countdown from three and gave the command to start. This setting was identical for all two pediatric emergency rulers and all two manikins. The time until each parameter was identified and the value of the parameter were recorded.
Primary outcome was the time needed to identify the four above defined parameters. Secondary outcome was the correctness of the identified parameters and the percentage deviation from the correct value.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8032
- University Childrens Hospital, Department of Anaesthesia and Children's Research Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich, Switzerland
- Written informed consent
Exclusion Criteria:
- Having worked with one of the pediatric emergency rulers and knowing where to find the defined parameters
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Resusci Baby
Resusci Baby used for the simulated emergency scenario
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usind the ePER for weight estimation and suggestion of the defined parameter
usind the BT for weight estimation and suggestion of the defined parameter
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Ambu® Junior
Ambu® Junior used for the simulated emergency scenario
|
usind the ePER for weight estimation and suggestion of the defined parameter
usind the BT for weight estimation and suggestion of the defined parameter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to identification
Time Frame: During simulation, approximately 30 minutes
|
Time needed to identify the four defined parameters
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During simulation, approximately 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correctness
Time Frame: During simulation, approximately 30 minutes
|
Correctness of the identified Parameter.
The from the participant identified value is compared with the per value defined correctly based on the manikin size.
|
During simulation, approximately 30 minutes
|
Percentage deviation
Time Frame: During simulation, approximately 30 minutes
|
If the Parameter was identified incorrectly, a percentage deviation of the identified value from the correct value will be calculated
|
During simulation, approximately 30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexander R Schmidt, MD, Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ePER vs BT
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.
Clinical Trials on Time Until Identification of Defined Parameter
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Clinical Trials on ePER
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University Children's Hospital, ZurichCompletedTime Until Identification of Defined ParameterSwitzerland