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

NCT ID: NCT02805192

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

627 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Growth and Development

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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one Arm: size measurement by Smart phone App

Group Type OTHER

Size Measurement by a Smart phone App

Intervention Type DEVICE

Interventions

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Size Measurement by a Smart phone App

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Philipp Stein

Dr. med. Philipp Stein

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donat R Spahn, M.D., F.R.C.A.

Role: STUDY_CHAIR

University and Universtity Hospital Zurich

Locations

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Universtity Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 28660564 (View on PubMed)

Other Identifiers

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KEK 2016-271, 94-2015

Identifier Type: -

Identifier Source: org_study_id

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