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Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment

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ClinicalTrials.gov Identifier: NCT00850083
Recruitment Status : Unknown
Verified February 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2009
Last Update Posted : February 24, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

Objective To evaluate the accuracy of data acquisition by Health e pod device in measurement of body temperature, to compare it to a standard body temperature measure equipment About 400 consecutive patients admitted to PEU in Assaf Harofeh Medical Center will compile the Study Population.

Basic vital signs will be recorded on admission and during hospitalization as per the PEU policy and not in particular for this study.

As a part of routine check-up all admitted patients undergo body temperature measure (oral or rectal - as per the PEU policy and with PEU devices).

Following an explanation and patient agreement, eligible patients (and their legal guardian) will sign informed consent and enter the study. The health e pod device will be applied to measure body temperature, immediately after the standard temperature measure has been performed by the PEU professional.


Condition or disease
All Children Admitted to the ED Children With Fever

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment
Study Start Date : March 2009
Estimated Primary Completion Date : December 2009
Groups and Cohorts

Group/Cohort
Children in the ED


Outcome Measures

Primary Outcome Measures :
  1. Agreament between measurments by Health e pod device and the gold standard reference device. [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children visiting the pediatric emergency unit
Criteria

Inclusion Criteria:

  • Signed an Informed Consent by the patients' legal custodian / guardian (and assent by the patient when applicable).
  • Age 0 to 18 years
  • Clinically stable patients hospitalized in PEU.

Exclusion Criteria:

  • Implanted pacemaker or defibrillator.
  • Patients participating in other clinical trail.
Contacts and Locations

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): NCT00850083


Contacts
Contact: Eran Kozer, MD 97289779916 erank@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Eran Kozer, MD    97289779916    erank@asaf.health.gov.il   
Principal Investigator: Eran Kozer, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information

Responsible Party: Eran Kozer, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00850083     History of Changes
Other Study ID Numbers: 152/08
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Keywords provided by Assaf-Harofeh Medical Center:
Fever
Children