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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorMedical College of Wisconsin

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Temple Touch Pro

    Device

    temporal artery temperature probe

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Temple Touch ProActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

DeRoyal Industries, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: