About this trial
The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Temple Touch Pro
Devicetemporal artery temperature probe
Treatment groups
Trial 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
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
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
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.
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
Sponsors and contacts
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Medical College of Wisconsin
Lead sponsor
DeRoyal Industries, Inc.
Collaborator
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