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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00850083
First received: February 23, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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
All Children Admitted to the ED
Children With Fever

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Agreament between measurments by Health e pod device and the gold standard reference device. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children in the ED

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eran Kozer, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00850083     History of Changes
Other Study ID Numbers: 152/08
Study First Received: February 23, 2009
Last Updated: February 23, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
Fever
Children

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014