Tympanic Thermometer Study

NCT06556628 | Active Not Recruiting FDA Device

• 1 other identifier: 60117201
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature Changes; Fever

Outcome Measures

Primary Outcomes (1)

• Clinical Bias

  The mean difference between output temperatures of the clinical thermometer under test

  Immediately after the diagnostic test

Secondary Outcomes (2)

• Repeatability

  Immediately after the diagnostic test

• Limits of Agreement

  Immediately after the diagnostic test

Study Arms (3)

Fever

Elevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher.

Device: Increased Body Temperatures

Healthy

Oral temperature between 36-37.4C Axillary temperature between 36-37.1C

Cold

Oral or axillary temperatures below 36C

Interventions

Increased Body Temperatures DEVICE

Collecting data on patients whose body temperatures increase due to fighting an illness.

Fever

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Baxter

Skaneateles, New York, 13153, United States

Location

MeSH Terms

Conditions

Body Temperature Changes; Fever

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 16, 2024
• Study Start: April 11, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)