- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02805192
Validation of a Smart Phone App to Non-invasively Measure the Size of Children
Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of medication if a valid weight or age is entered. During emergency situations, these values are often unknown. An App has been developed to measure the size of a child noninvasively. This App is now to be validated in clinical practice. App measured size is calculated and compared to the real size of a child. Via known percentiles of age/weight of the child is calculated upon the App measured size. This value is compared to the mother's, physician's and nurses estimation of the size and weight.
Depending on the size multiple algorithms exist to estimate weight, age and medical values. ("Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®"). These estimations by the calculations will also be compared to actual weight and age.
Children from 0-12 years of age are included in the emergency Department of the Children's Hospital of the University of Zurich after informed consent obtained by the parents. No therapy decisions from these calculations will be made. The therapy is independent of this study.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Zurich, Sveits, 8091
- Universtity Hospital Zurich
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- male and female patients 0-12 years of age (45 per age group)
- obtained informed consent
- admitted to the emergency department of the Children's Hospital of the University of Zurich
Exclusion Criteria:
- physically or mentally unable for measurement
- denial of informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: one Arm: size measurement by Smart phone App
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Comparison of the size measured by the smart phone app with the child's size.
Tidsramme: immediate, no follow up
|
immediate, no follow up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.
Tidsramme: immediate, no follow up
|
immediate, no follow up
|
|
Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.
Tidsramme: immediate, no follow up
|
immediate, no follow up
|
|
Comparison of estimations by parents, physicians and nurses with the actual size and weight.
Tidsramme: immediate, no follow up
|
immediate, no follow up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Donat R Spahn, M.D., F.R.C.A., University and Universtity Hospital Zurich
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- KEK 2016-271, 94-2015
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. .