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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00378846
First received: September 19, 2006
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Fever, Sweats, and Hot Flashes
 Procedure: infrared thermography

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: A Study Evaluating the Agreement of Devices for Measuring Temperature in Children

Resource links provided by NLM:

MedlinePlus related topics: Fever Sweat
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring [ Designated as safety issue: No ]
  • Differences in agreement of the various temperature devices [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: March 2006
Study Completion Date: November 2009
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

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378846

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas J. Walsh, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00378846     History of Changes
Other Study ID Numbers: 060118, 06-C-0118, NCI-P6842, CDR0000496917
Study First Received: September 19, 2006
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
fever, sweats, and hot flashes

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

ClinicalTrials.gov processed this record on May 23, 2013