Non-invasive Temperature Monitoring in Pediatric Intensive Care Patients Requiring Targeted Temperature Management: Evaluation of Temple Touch Pro

March 27, 2026 updated by: Kayla Duvall, MD, Medical College of Wisconsin
The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study evaluates the use of Temple Touch Pro (TTP), a noninvasive method of measuring core temperature, in critical care pediatric patients that require targeted temperature management. These patients currently require two probes placed in the following locations to appropriately control the temperature therapy: esophageal, bladder, and/or rectum.

Both the bladder and rectum locations have limitations and risks that Temple Touch Pro could address. Following patient screening and consent, Temple Touch Pro (TTP) will be added as a third temperature monitoring modality.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53222-3840
        • Children's Wisconsin
        • Contact:
        • Principal Investigator:
          • Kayla Duvall, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 0 to less than 18 years of age
  2. PICU Diagnosis requiring targeted temperature management. For example traumatic brain injury, cardiac arrest, or anoxic brain injury
  3. Requires continuous temperature monitoring with a foley catheter (bladder) or a general purpose probe placed in the esophagus.
  4. Enrolled within 24 hours of start of continuous temperature monitoring.
  5. Patient has adequate forehead space to accommodate the TTP sensor
  6. Temporal artery perfusion not compromised by injury or other pathology
  7. No surgical procedure planned for 72 hours
  8. Targeted temperature management expected for at least 24 hours at time of consent

Exclusion Criteria:

  1. Already enrolled in another trial addressing temperature management
  2. Allergy to medical grade acrylic adhesive
  3. Patient does not tolerate placement of TTP sensor on forehead
  4. Contraindication to the placement of two or more of Foley, esophageal, and rectal temperature probes.
  5. A history of skin irritation, skin sensitivity, or skin disease, including psoriasis, eczema, atopic dermatitis, and skin cancer.
  6. Pregnant or lactating female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Temple Touch Pro
Device: Temple Touch Pro
temporal artery temperature probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of temperature pairs between TTP and three core locations
Time Frame: From enrollment to the end of treatment (min. 10 hours)
Bland-Altman analysis of temperature pairs between TTP and three core locations to determine bias and 95% limits of agreement during targeted temperature management
From enrollment to the end of treatment (min. 10 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of temperature pairs of bladder and rectal to esophageal temperature recordings
Time Frame: From enrollment to the end of treatment (min. 10 hours)
Bland Altman analysis of temperature pairs of bladder and rectal to esophageal temperature recordings to determine bias and 95% limits of agreement during targeted temperature management
From enrollment to the end of treatment (min. 10 hours)
Analysis of temperature pairs between rectal and bladder
Time Frame: From enrollment to the end of treatment (min. 10 hours)
Bland Altman analysis of temperature pairs between rectal and bladder to determine bias and 95% limits of agreement during targeted temperature management
From enrollment to the end of treatment (min. 10 hours)
Analysis of temperature pairs between TTP and three core locations
Time Frame: From enrollment to 24 hours after targeted temperature management.
Bland-Altman analysis of temperature pairs between TTP and three core locations to determine bias and 95% limits of agreement during the 24 hours after targeted temperature management.
From enrollment to 24 hours after targeted temperature management.
Analysis of temperature pairs of bladder and rectal to esophageal temperature
Time Frame: From enrollment to 24 hours after targeted temperature management.
Bland Altman analysis of temperature pairs of bladder and rectal to esophageal temperature recordings to determine bias and 95% limits of agreement during 24 hours after targeted temperature management
From enrollment to 24 hours after targeted temperature management.
Analysis of temperature pairs between rectal and bladder
Time Frame: From enrollment to 24 hours after targeted temperature management.
Bland Altman analysis of temperature pairs between rectal and bladder to determine bias and 95% limits of agreement during 24 hours after targeted temperature management
From enrollment to 24 hours after targeted temperature management.
Difference between the control and experimental (TTP) measurements
Time Frame: From enrollment to the end of treatment (min. 10 hours)
Error grid analysis to determine if difference between the control and experimental measurements would lead to incorrect temperature management.
From enrollment to the end of treatment (min. 10 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

DeRoyal Industries, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO00057443

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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