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

N/ANot Yet RecruitingNCT07507396

Medical College of Wisconsin20 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Temperature Monitoring

Interventions

Temple Touch ProDEVICE

temporal artery temperature probe

Eligibility

Sex: ALLMin age: 0 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Analysis of temperature pairs between TTP and three core locations

Bland-Altman analysis of temperature pairs between TTP and three core locations to determine bias and 95% limits of agreement during targeted temperature management

Time frame: From enrollment to the end of treatment (min. 10 hours)

Secondary Outcomes

Analysis of temperature pairs of bladder and rectal to esophageal temperature recordings

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

Time frame: From enrollment to the end of treatment (min. 10 hours)

Analysis of temperature pairs between rectal and bladder

Bland Altman analysis of temperature pairs between rectal and bladder to determine bias and 95% limits of agreement during targeted temperature management

Time frame: From enrollment to the end of treatment (min. 10 hours)

Analysis of temperature pairs between TTP and three core locations

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.

Time frame: From enrollment to 24 hours after targeted temperature management.

Analysis of temperature pairs of bladder and rectal to esophageal temperature

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

Time frame: From enrollment to 24 hours after targeted temperature management.

Analysis of temperature pairs between rectal and bladder

Central Contacts

Kayla Duvall, MD

CONTACT

414-266-3360 kduvall@mcw.edu

Data from ClinicalTrials.gov

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