Febrile Illness Clinical Trial
Official title:
TIMMY3 80601-2-56:2017 + A1 2018 Clinical Accuracy Study
Verified date | May 2024 |
Source | Baxter Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
Status | Enrolling by invitation |
Enrollment | 420 |
Est. completion date | December 15, 2024 |
Est. primary completion date | November 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 99 Years |
Eligibility | Inclusion Criteria: - Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study: - Subjects that are between 7 and 17 years of age must provide assent to participate in the study. - Subjects must be able to provide an informed consent or have legally authorized representative consent to participate. - Subject must be willing and able to comply with the study procedures. - Age: normal weight (full-term) newborn to adult - The study subject is in ambient temperature for at least 20 minutes prior to participating. - The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site. - The study subject is not physically or emotionally agitated/uncooperative. - The study subject or legal guardian speaks/understands fluent English. Exclusion Criteria: - Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced. - The study subject has anatomical abnormalities that would affect temperature. - The study subject has any known contraindication to oral, axillary, or rectal temperature measurements. - The study subject or their legally authorized representative (LAR) refuses to allow the study subject to participate for any reason. - The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken. - The study subject 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 study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.). - Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes. - Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations). - Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria. Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time. |
Country | Name | City | State |
---|---|---|---|
United States | John R. Oishei Children's Hospital | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Forest Lane Pediatrics | Dallas | Texas |
United States | First Georgia Physicians Group | Fayetteville | Georgia |
United States | Mankato Clinic | Mankato | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validate the Clinical Accuracy of the Timmy3 thermometer algorithm | All age groups in the oral, adult and pediatric axillary, and rectal temperature modes. Clinical accuracy will include measurement of clinical bias, with its limits of agreement, and clinical repeatability as defined by the ISO 80601-2-56:2017 + A1:2018. | Up to 2 years |
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