Clinical trial NCT06556628: Tympanic Thermometer Study
Official title: Disco Thermometer Engineering Study Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Body Temperature Changes
Fever
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects recruited to participate in this study may range in age from normal weight (≥2.5kg), full-term (37 weeks gestation) newborns to geriatric adults. The subject may be anyone who is willing to have their temperature taken who also meets the eligibility criteria. Study subjects may have normal, febrile, or cold temperatures.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Bias
timeFrame: Immediately after the diagnostic test
Secondary outcomes:
measure: Repeatability
timeFrame: Immediately after the diagnostic test
measure: Limits of Agreement
timeFrame: Immediately after the diagnostic test
Other outcomes:
Locations:
city: Skaneateles
country: United States
facility: Baxter
state: New York
Study officials:
References: