Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

25. august 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

33

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Resusci Baby
Resusci Baby brukes til det simulerte nødscenarioet
see detailed description of methods
Ambu® Junior
Ambu® Junior brukt for det simulerte nødscenarioet
see detailed description of methods
MegaCode-Kid
MegaCode-Kid used for the simulated emergency scenario
see detailed description of methods

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tid til identifikasjon
Tidsramme: Under simulering, ca. 30 minutter
Tid som trengs for å identifisere de fire definerte parameterne
Under simulering, ca. 30 minutter

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Korrekthet
Tidsramme: Under simulering, ca. 30 minutter
Riktigheten til den identifiserte parameteren. Den identifiserte verdien fra deltakeren sammenlignes med per-verdien definert korrekt basert på dukkestørrelsen.
Under simulering, ca. 30 minutter
Prosentvis avvik
Tidsramme: Under simulering, ca. 30 minutter
Hvis parameteren ble identifisert feil, vil et prosentvis avvik fra den identifiserte verdien fra den riktige verdien bli beregnet
Under simulering, ca. 30 minutter

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. april 2018

Primær fullføring (Faktiske)

5. juni 2018

Studiet fullført (Faktiske)

28. juni 2018

Datoer for studieregistrering

Først innsendt

8. juli 2018

Først innsendt som oppfylte QC-kriteriene

25. august 2018

Først lagt ut (Faktiske)

28. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ePER vs PS vs PNL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på ePER vs PS vs PaedER

3
Abonnere