Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378846
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2006-09-19
Brief Title:
Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study Evaluating the Agreement of Devices for Measuring Temperature in Children
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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 patients 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
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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000496917 | None | None | None |
| 06-C-0118 | None | None | None |
| NCI-P6842 | None | None | None |