Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever

Fever, Sweats, and Hot Flashes Clinical Trial

Official title:

A Study Evaluating the Agreement of Devices for Measuring Temperature in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378846
• Other study ID #: 060118
• Secondary ID: 06-C-0118NCI-P68
• Status: Completed
• Phase: N/A
• First received: September 19, 2006
• Last updated: March 14, 2012
• Start date: March 2006
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Comparing results of three different thermometers used to measure body temperature may help doctors find the most accurate thermometer to detect fever and plan the best treatment.

PURPOSE: This clinical trial is studying three different types of thermometers to measure temperature in young patients with fever and without fever.

Description:

OBJECTIVES:

Primary

• Determine agreement between three different types of temperature-measuring instruments:

the temporal artery scanner, the digital oral thermometer, and the infrared tympanic thermometer calibrated to an oral setting, in pediatric patients who are febrile and afebrile.

Secondary

• Determine similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring in these pediatric patients.

• Determine differences in agreement of the various temperature devices in non-neutropenic pediatric patients versus neutropenic pediatric patients.

OUTLINE: This is a prospective study.

During an afebrile episode, the patient's temperature is measured twice using the following 3 devices: a temporal artery scanner, a digital oral thermometer, and an infrared tympanic thermometer calibrated to an oral setting (total of 6 temperature measurements per afebrile episode).

During a febrile episode, the patient's temperature is measured twice using all 3 devices as above, and then at 2 and 4 hours after administration of an antipyretic medication (total of 18 temperatures per febrile episode).

Patients' temperatures are recorded for a maximum of 3 afebrile or febrile episodes.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

DISEASE CHARACTERISTICS:

• Febrile or afebrile

• Patient at the Mark O. Harfield Clinical Research Center

• Previously enrolled in an IRB-approved Clinical Center protocol

PATIENT CHARACTERISTICS:

• Able to hold an oral thermometer in mouth

• No acute life-threatening infection

• No ear, nose, or throat (aural) abnormalities

• No severe mucositis

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No concurrent enrollment on a behavioral research study

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fever
• Fever, Sweats, and Hot Flashes
• Hot Flashes

Intervention

Procedure:
• infrared thermography

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between the temporal artery scanner, digital oral thermometer, and infrared tympanic thermometer calibrated to an oral setting in pediatric patients who are febrile and afebrile			No
Secondary	Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring			No
Secondary	Differences in agreement of the various temperature devices			No