Tympanic Thermometer Study | NCT06556628

Studies
Tympanic Thermometer Study

NCT06556628

Sponsor

Baxter Healthcare Corporation

Status

Active, not recruiting

Last Update Posted

Aug 16, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Body Temperature Changes
Fever

Interventions

Increased Body Temperatures

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2022Actual

Primary Completion Date

May 31, 2025Estimated

Completion Date

May 31, 2025Estimated

First Submitted Date

Aug 12, 2024

First Submission Date that Met QC Criteria

Aug 14, 2024

First Posted Date

Aug 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2024

Last Update Posted Date

Aug 16, 2024Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Increased Body Temperatures	Device	Collecting data on patients whose body temperatures increase due to fighting an illness.	Fever

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001832	Body Temperature Changes
D005334	Fever