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NCT Number: NCT06556628

Tympanic Thermometer Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Baxter

Skaneateles, New York, 13153, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Increased Body Temperatures

Device

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

Primary outcomes

  1. Clinical Bias

    Time frame: Immediately after the diagnostic test

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

Secondary outcomes

  1. Repeatability

    Time frame: Immediately after the diagnostic test

    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

  2. Limits of Agreement

    Time frame: Immediately after the diagnostic test

    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.

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

Disco Thermometer Engineering Study Protocol

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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