Evaluating Different Pediatric Emergency Rulers in a Manikin Study - How Fast and Correct Are They

August 25, 2018 updated by: University Children's Hospital, Zurich

Comparison of three 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

Completed

Intervention / Treatment

Detailed Description

Medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich 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) is based on the Continuous Length-based Algorithm for Weight & Age Rating (CLAWAR). This digital algorithm is based on gender-specific Swiss length-weight and Swiss length-age growth charts and uses the 50th percentile to estimate the patient's body weight and age. CLAWAR was recently published and showed a higher accuracy compared to a conventional emergency tape. A smartphone application (APP) was programmed based on CLAWAR and is utilized in the ePER. CLAWAR, the APP and ePER were developed by the department of Anaesthesia at the University Children's Hospital Zurich.

The "Paulino System" (PS; Paulino-System & Altonaer Werbewerkstatt, Hamburg, Germany) utilizes a ruler with 27 length-based weight categories for a body length from 44 to 151 cm. Separate from this ruler weight estimation ruler drug dosing, sizes of medical equipment, and vital parameters for each of the 27 weight categories can be found in a color-coded booklet.

The "Paediatric Emergency Ruler" (PaedER; Alpha 1 Werbedesign e.K., Falkenberg, Germany) is a paediatric emergency tape certified for clinical use in Europe and applicable for patients with a body length between 44 and 140 cm. PaedER is grouped in 11 length based weight categories to assist estimation of patients' body weight, to suggest drug dosing (mg and ml) for the most common emergency drugs and to recommend adequate sizes of medical equipment and norm-values for vital signs. The basic idea is identical to the of the Broselow Luten tape.

All participants were instructed for the use of the three 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 three different manikins:

  • Resusci Baby, Laerdal/Dräger Medical Switzerland AG, Liebefeld, Switzerland
  • MegaCode-Kid, 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 three pediatric emergency rulers and all three 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

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zürich, Switzerland, 8032
        • Department of Anaesthesia and Children's Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich

Description

Inclusion Criteria:

  • Medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich
  • Written informed consent

Exclusion Criteria:

  • Having worked with one of the pediatric emergency rulers and knowing where to find the defined parameters

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Resusci Baby
Resusci Baby used for the simulated emergency scenario
see detailed description of methods
Ambu® Junior
Ambu® Junior used for the simulated emergency scenario
see detailed description of methods
MegaCode-Kid
MegaCode-Kid used for the simulated emergency scenario
see detailed description of methods

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander R Schmidt, MD, Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

June 28, 2018

Study Registration Dates

First Submitted

July 8, 2018

First Submitted That Met QC Criteria

August 25, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 25, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ePER vs PS vs PNL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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