Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

TIMMY3 80601-2-56:2017 + A1 2018 Clinical Accuracy Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Febrile Illness
• Intervention / Treatment: Device: Connex CSVM with Timmy3 module

Detailed Description

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.

This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina King, M.S.; Phone Number: 812-931-0374; Email: kristina_king@baxter.com
• Study Contact Backup: Name: Ashley Wagoner, Ph.D.; Phone Number: 336-391-1829; Email: Ashley_Wagoner@baxter.com

Study Locations

• United States
  • Georgia
    • Fayetteville, Georgia, United States, 30214
      • First Georgia Physicians Group
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Mankato Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75230
      • Forest Lane Pediatrics

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Temperature Measurement; Oral temperature measurements for subjects age Group C as 5 years or older. Both febrile and non-febrile subjects included in this arm.	Device: Connex CSVM with Timmy3 module; Connex Vital Signs Monitor with the Timmy3 Investigational module
Experimental: Axillary Temperature Measurement; Adult Axillary temperature measurement supports age Group C where C contains 18 years and older subjects. Pediatric Axillary temperature measurement supports newborn to 5 years and less than 18 years old. Both febrile and non-febrile subjects included in this arm.	Device: Connex CSVM with Timmy3 module; Connex Vital Signs Monitor with the Timmy3 Investigational module
Experimental: Rectal Temperature Measurement; Rectal temperature measurements for all age groups (newborn to subjects older than 18 years of age) with no restrictions. Both febrile and non-febrile subjects included in this arm.	Device: Connex CSVM with Timmy3 module; Connex Vital Signs Monitor with the Timmy3 Investigational module

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Eric Fernandez, M.D., Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 60128116

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: No
• product manufactured in and exported from the U.S.: No