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Electronic Pediatric Emergency Ruler vs the Broselow Tape. (ePERvsBT)
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 |
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 : | 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
|
- Time to identification [ Time Frame: During simulation, approximately 30 minutes ]Time needed to identify the four defined parameters
- 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.
- 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
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
| Switzerland | |
| University Childrens Hospital, Department of Anaesthesia and Children's Research Centre | |
| Zurich, Switzerland, 8032 | |
| Principal Investigator: | Alexander R Schmidt, MD | Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 14, 2019 | ||||
| First Posted Date | May 16, 2019 | ||||
| Last Update Posted Date | May 20, 2019 | ||||
| Actual Study Start Date | January 5, 2019 | ||||
| Actual Primary Completion Date | February 8, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Time to identification [ Time Frame: During simulation, approximately 30 minutes ] Time needed to identify the four defined parameters
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Electronic Pediatric Emergency Ruler vs the Broselow Tape. | ||||
| Official Title | Electronic Pediatric Emergency Ruler vs the Broselow Tape in a Simulated Pediatric Emergency Scenario | ||||
| 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. |
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| 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 | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich, Switzerland | ||||
| Condition | Time Until Identification of Defined Parameter | ||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
20 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 20, 2019 | ||||
| Actual Primary Completion Date | February 8, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03953105 | ||||
| Other Study ID Numbers | ePER vs BT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Children's Hospital, Zurich | ||||
| Study Sponsor | University Children's Hospital, Zurich | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Children's Hospital, Zurich | ||||
| Verification Date | May 2019 | ||||
