Validation of a Smart Phone App to Non-invasively Measure the Size of Children

Growth and Development Clinical Trial

Official title:

Validation of a Smart Phone App to Non-invasively Measure the Size of Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805192
• Other study ID #: KEK 2016-271, 94-2015
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: May 2, 2017
• Start date: January 30, 2016
• Est. completion date: June 30, 2016

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth and Development

Intervention

Device:
• Size Measurement by a Smart phone App

Locations

Country	Name	City	State
Switzerland	Universtity Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the size measured by the smart phone app with the child`s size.		immediate, no follow up
Secondary	Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.		immediate, no follow up
Secondary	Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.		immediate, no follow up
Secondary	Comparison of estimations by parents, physicians and nurses with the actual size and weight.		immediate, no follow up