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Electronic Pediatric Emergency Ruler vs the Broselow Tape. (ePERvsBT)

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ClinicalTrials.gov Identifier: NCT03953105
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief 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.


Condition or disease Intervention/treatment
Time Until Identification of Defined Parameter Device: ePER Device: BT

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Electronic Pediatric Emergency Ruler vs the Broselow Tape in a Simulated Pediatric Emergency Scenario
Actual Study Start Date : January 5, 2019
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 20, 2019

Group/Cohort Intervention/treatment
Resusci Baby
Resusci Baby used for the simulated emergency scenario
Device: ePER
usind the ePER for weight estimation and suggestion of the defined parameter

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

Ambu® Junior
Ambu® Junior used for the simulated emergency scenario
Device: ePER
usind the ePER for weight estimation and suggestion of the defined parameter

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




Primary Outcome Measures :
  1. Time to identification [ Time Frame: During simulation, approximately 30 minutes ]
    Time needed to identify the four defined parameters


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich, Switzerland
Criteria

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

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): NCT03953105


Locations
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Switzerland
University Childrens Hospital, Department of Anaesthesia and Children's Research Centre
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Alexander R Schmidt, MD Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland

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Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03953105     History of Changes
Other Study ID Numbers: ePER vs BT
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Children's Hospital, Zurich:
Weight estimation
Patient safety

Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes