Clinical trial NCT00378846: Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever
Official title: A Study Evaluating the Agreement of Devices for Measuring Temperature in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever, Sweats, and Hot Flashes
Keywords: fever, sweats, and hot flashes
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring
measure: Differences in agreement of the various temperature devices
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Thomas J. Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: