Tympanic Thermometer Study

Disco Thermometer Engineering Study Protocol

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fever; Body Temperature Changes
• Intervention / Treatment: Device: Increased Body Temperatures

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • Skaneateles, New York, United States, 13153
      • Baxter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fever; Elevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher.	Device: 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
Cold; Oral or axillary temperatures below 36C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Bias	The mean difference between output temperatures of the clinical thermometer under test	Immediately after the diagnostic test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability	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	Immediately after the diagnostic test
Limits of Agreement	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.	Immediately after the diagnostic test

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 60117201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No