Temperature Monitoring
Conditions
Keywords
temperature monitoring, Temple Touch Pro, esophageal, rectum, bladder, temporal artery
Brief summary
The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.
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.
Interventions
DEVICETemple Touch Pro
temporal artery temperature probe
Sponsors
Medical College of Wisconsin
DeRoyal Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of temperature pairs between TTP and three core locations | 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
| Measure | Time frame | Description |
|---|---|---|
| Analysis of temperature pairs of bladder and rectal to esophageal temperature recordings | 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 |
| Analysis of temperature pairs between rectal and bladder | 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 |
| Analysis of temperature pairs between TTP and three core locations | 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. |
| Analysis of temperature pairs of bladder and rectal to esophageal temperature | 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 |
| Difference between the control and experimental (TTP) measurements | 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. |
Countries
United States
Contacts
CONTACTKayla Duvall, MD
Outcome results
None listed