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

May 2, 2017 updated by: Philipp Stein, University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

627

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Universtity Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: one Arm: size measurement by Smart phone App
Device: Size Measurement by a Smart phone App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the size measured by the smart phone app with the child's size.
Time Frame: immediate, no follow up
immediate, no follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.
Time Frame: immediate, no follow up
immediate, no follow up
Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.
Time Frame: immediate, no follow up
immediate, no follow up
Comparison of estimations by parents, physicians and nurses with the actual size and weight.
Time Frame: immediate, no follow up
immediate, no follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Chair: Donat R Spahn, M.D., F.R.C.A., University and Universtity Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 30, 2016

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KEK 2016-271, 94-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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