Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2022-04-11
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Fever
Elevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher.
Increased Body Temperatures
Collecting data on patients whose body temperatures increase due to fighting an illness.
Healthy
Oral temperature between 36-37.4C Axillary temperature between 36-37.1C
No interventions assigned to this group
Cold
Oral or axillary temperatures below 36C
No interventions assigned to this group
Interventions
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Increased Body Temperatures
Collecting data on patients whose body temperatures increase due to fighting an illness.
Eligibility Criteria
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Inclusion Criteria
* Participant, legal guardian, or healthcare proxy is able to give consent to participate.
* Participant, legal guardian, or healthcare proxy speaks fluent English.
* 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.
ALL
Yes
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Locations
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Baxter
Skaneateles, New York, United States
Countries
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Other Identifiers
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60117201
Identifier Type: -
Identifier Source: org_study_id
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