NCT02805192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
627

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

June 10, 2016

Last Update Submit

May 2, 2017

Conditions

Keywords

Emergency DepartmentEstimation of age and weightSize measurement

Outcome Measures

Primary Outcomes (1)

  • Comparison of the size measured by the smart phone app with the child's size.

    immediate, no follow up

Secondary Outcomes (3)

  • Comparison of the estimations calculated upon the smart phone measured size (via known percentiles) with the real age and weight.

    immediate, no follow up

  • Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight.

    immediate, no follow up

  • Comparison of estimations by parents, physicians and nurses with the actual size and weight.

    immediate, no follow up

Study Arms (1)

one Arm: size measurement by Smart phone App

OTHER
Device: Size Measurement by a Smart phone App

Interventions

one Arm: size measurement by Smart phone App

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • physically or mentally unable for measurement
  • denial of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universtity Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

EmergenciesBody Weight

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Donat R Spahn, M.D., F.R.C.A.

    University and Universtity Hospital Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Philipp Stein

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 17, 2016

Study Start

January 30, 2016

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations