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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805192
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Philipp Stein, University of Zurich

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.


Condition or disease Intervention/treatment Phase
Growth and Development Device: Size Measurement by a Smart phone App Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 627 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Validation of a Smart Phone App to Non-invasively Measure the Size of Children
Study Start Date : January 30, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Arm Intervention/treatment
one Arm: size measurement by Smart phone App Device: Size Measurement by a Smart phone App



Primary Outcome Measures :
  1. Comparison of the size measured by the smart phone app with the child's size. [ Time Frame: immediate, no follow up ]

Secondary Outcome Measures :
  1. 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 ]
  2. Comparison of estimations by "Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®" with real age and weight. [ Time Frame: immediate, no follow up ]
  3. Comparison of estimations by parents, physicians and nurses with the actual size and weight. [ Time Frame: immediate, no follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805192


Locations
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Switzerland
Universtity Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Donat R Spahn, M.D., F.R.C.A. University and Universtity Hospital Zurich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philipp Stein, Dr. med. Philipp Stein, University of Zurich
ClinicalTrials.gov Identifier: NCT02805192    
Other Study ID Numbers: KEK 2016-271, 94-2015
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Philipp Stein, University of Zurich:
Emergency Department
Estimation of age and weight
Size measurement