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

All Children Admitted to the ED Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00850083
• Other study ID #: 152/08
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2009
• Last updated: February 23, 2009
• Start date: March 2009

Study information

• Verified date: February 2009
• Source: Assaf-Harofeh Medical Center
• Contact: Eran Kozer, MD
• Phone: 97289779916
• Email: erank[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• All Children Admitted to the ED
• Children With Fever

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreament between measurments by Health e pod device and the gold standard reference device.		one year	No