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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03953105
Other study ID # ePER vs BT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2019
Est. completion date February 20, 2019

Study information

Verified date May 2019
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 20, 2019
Est. primary completion date February 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Emergencies
  • Time Until Identification of Defined Parameter

Intervention

Device:
ePER
usind the ePER for weight estimation and suggestion of the defined parameter
BT
usind the BT for weight estimation and suggestion of the defined parameter

Locations

Country Name City State
Switzerland University Childrens Hospital, Department of Anaesthesia and Children's Research Centre Zurich

Sponsors (1)

Lead Sponsor Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to identification Time needed to identify the four defined parameters During simulation, approximately 30 minutes
Secondary Correctness 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
Secondary Percentage deviation 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
See also
  Status Clinical Trial Phase
Completed NCT03650296 - Evaluating Different Pediatric Emergency Rulers in a Manikin Study - How Fast and Correct Are They