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NCT Number: NCT07507396

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

The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Wisconsin

Milwaukee, Wisconsin, 53222-3840, United States

Location contact

Kayla Duvall, MD

PRINCIPAL_INVESTIGATOR

Melissa McEachern, MA

CONTACT

[email protected]

414-266-3642

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Temple Touch Pro

Device

temporal artery temperature probe

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Duvall, MD

CONTACT

[email protected]

414-266-3360

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • DeRoyal Industries, Inc.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

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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