Tympanic Thermometer Study

Active, not recruiting

• Conditions: Body Temperature Changes; Fever
• Interventions: Device: Increased Body Temperatures

• Registration Number: NCT06556628
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age: normal weight (≥2.5kg), full-term (37 weeks gestation) newborn to geriatric adult.
• Participant, legal guardian, or healthcare proxy is able to give consent to participate.
• Participant, legal guardian, or healthcare proxy speaks fluent English.

Exclusion Criteria

• The subject does not meet the inclusion criteria.
• The subject has anatomical abnormalities that would affect temperature.
• The subject has blood or drainage in the external ear canal.
• The subject has had something in their ear for a prolonged period, such as a hearing aid or headphones. The subject may be included if the hearing aid or headphones are removed at least 30 minutes prior to taking ear temperature.
• The subject has been lying on ear within 30 minutes of data collection. The subject may be included if they wait 30 minutes prior to having an ear temperature measurement taken.
• The subject exhibits symptoms of an acute or chronic inflammatory condition of the external ear canal. An example would be swimmer's ear. The subject may be included if the acute or chronic inflammatory condition is isolated to one ear, then the other ear may be used for data collection.
• The subject has an ear obstruction or excess cerumen build-up.
• The subject is in acute distress, i.e., severe pain, severe emotional distress or agitation that would inhibit them from participating in a tympanic ear temperature study.
• The subject has any known contraindication to oral, ear, or axillary temperature measurements.
• The subject has used ear drops in the last 8 hours. The subject may be included if the other ear was not medicated with ear drops in the last 8 hours.
• The subject (age 5+) has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
• The subject has taken an antipyretic (ex: Tylenol, Motrin, Aspirin) in the last 120 minutes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fever	Increased Body Temperatures	Elevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher.

Primary Outcome Measures

Name	Time	Method
Clinical Bias	Immediately after the diagnostic test	The mean difference between output temperatures of the clinical thermometer under test

Secondary Outcome Measures

Name	Time	Method
Limits of Agreement	Immediately after the diagnostic test	The magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperature differences when used on the same human subject.
Repeatability	Immediately after the diagnostic test	Pooled standard deviation (over a selected group of subjects) of changes in multiple output temperatures taken from the same subject at the same measuring site with the same clinical thermometer by the same operator within a relatively short time

Trial Locations

Locations (1)

Baxter; 🇺🇸 Skaneateles, New York, United States