Time Until Identification of Defined ParameterNCT03650296
Evaluating Different Pediatric Emergency Rulers in a Manikin Study - How Fast and Correct Are They
An observational study of Time Until Identification of Defined Parameter, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Until Identification of Defined Parameter
- What is being tested?
- ePER vs PS vs PaedER
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Apr 2018to 28 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich
Who may be able to join
- Medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich
- Written informed consent
Who cannot join
- Having worked with one of the pediatric emergency rulers and knowing where to find the defined parameters
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesia and Children's Research Centre
Zurich, 8032
About this study
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.
Read the 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.
- Being tested
- ePER vs PS vs PaedER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePER vs PS vs PaedERDevice
see detailed description of methods
| Study group | Role | What they receive |
|---|---|---|
| Resusci Baby | Resusci Baby used for the simulated emergency scenario Receives: Device: ePER vs PS vs PaedER | |
| MegaCode-Kid | MegaCode-Kid used for the simulated emergency scenario Receives: Device: ePER vs PS vs PaedER | |
| Ambu® Junior | Ambu® Junior used for the simulated emergency scenario Receives: Device: ePER vs PS vs PaedER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to identification
Time needed to identify the four defined parameters
Measured: During simulation, approximately 30 minutes
Secondary outcomes (2)
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.
Measured: During simulation, approximately 30 minutes
Percentage deviation
If the Parameter was identified incorrectly, a percentage deviation of the identified value from the correct value will be calculated
Measured: During simulation, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start2 Apr 2018
- Primary completion5 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Until Identification of Defined ParameterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander R Schmidt, MD, Principal investigator, Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650296
- Sponsor's protocol ID
- ePER vs PS vs PNL
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2018
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Different Pediatric Emergency Rulers in a Manikin Study - How Fast and Correct Are They
- ClinicalTrials.gov ID
- NCT03650296
- Acronym / sponsor ID
- ePER vs PS vs PNL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resusci Baby | – | Device: ePER vs PS vs PaedERResusci Baby used for the simulated emergency scenario |
| MegaCode-Kid | – | Device: ePER vs PS vs PaedERMegaCode-Kid used for the simulated emergency scenario |
| Ambu® Junior | – | Device: ePER vs PS vs PaedERAmbu® Junior used for the simulated emergency scenario |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich
Key inclusion criteria (2 listed)
- Medical team members (consultants, residents and nurses) of the department of Anaesthesia at the University Children's Hospital Zurich
- Written informed consent
Key exclusion criteria (1 listed)
- Having worked with one of the pediatric emergency rulers and knowing where to find the defined parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePER vs PS vs PaedERsee detailed description of methods | Device | Ambu® Junior, MegaCode-Kid, Resusci Baby |
Primary outcome
Time to identification
Time frame: During simulation, approximately 30 minutes
Time needed to identify the four defined parameters
2 secondary outcomes
Correctness
Time frame: During simulation, approximately 30 minutes
Percentage deviation
Time frame: During simulation, approximately 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander R Schmidt, MD principal investigator
Department of Anaesthesia and Children's Research Centre, University Children's Hospital, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Time Until Identification of Defined Parameter, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to identification (time frame: During simulation, approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.