Tympanic Thermometer Study

Running, not enrolling

Conditions studied: Body Temperature Changes, Fever

In brief

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.

Key facts

Study ID

NCT06556628

Run by

Baxter Healthcare Corporation

People needed

1000

Starts

2022-04-11

Expected to finish

2025-05-31

Last updated by the study team

2024-08-16

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baxter — Skaneateles, New York, United States

Full record on ClinicalTrials.gov

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