Clinical trial NCT02805192: Validation of a Smart Phone App to Non-invasively Measure the Size of Children
Official title: Validation of a Smart Phone App to Non-invasively Measure the Size of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Keywords: Emergency Department
Estimation of age and weight
Size measurement
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 627
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the size measured by the smart phone app with the child's size.
timeFrame: immediate, no follow up
Secondary outcomes:
measure: Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.
timeFrame: immediate, no follow up
measure: Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.
timeFrame: immediate, no follow up
measure: Comparison of estimations by parents, physicians and nurses with the actual size and weight.
timeFrame: immediate, no follow up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Universtity Hospital Zurich
Study officials:
affiliation: University and Universtity Hospital Zurich
name: Donat R Spahn, M.D., F.R.C.A.
role: STUDY_CHAIR
References:
citation: Wetzel O, Schmidt AR, Seiler M, Scaramuzza D, Seifert B, Spahn DR, Stein P. A smartphone application to determine body length for body weight estimation in children: a prospective clinical trial. J Clin Monit Comput. 2018 Jun;32(3):571-578. doi: 10.1007/s10877-017-0041-z. Epub 2017 Jun 28.