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

NCT07507396 | Not Yet Recruiting FDA Device

• 1 other identifier: PRO00057443
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Monitoring

Keywords

temperature monitoring; Temple Touch Pro; esophageal; rectum; bladder; temporal artery

Outcome Measures

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

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

Secondary Outcomes (6)

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

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

• Analysis of temperature pairs between rectal and bladder

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

• Analysis of temperature pairs between TTP and three core locations

  From enrollment to 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.

• Analysis of temperature pairs between rectal and bladder

  From enrollment to 24 hours after targeted temperature management.

Study Arms (1)

Temple Touch Pro

ACTIVE COMPARATOR

Device: Temple Touch Pro

Interventions

Temple Touch Pro DEVICE

temporal artery temperature probe

Temple Touch Pro

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• DeRoyal Industries, Inc.: collaborator

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53222-3840, United States

Location

Related Publications (13)

• Uminska JM, Buszko K, Ratajczak J, Lach P, Pstragowski K, Dabrowska A, Adamski P, Skonieczny G, Manitius J, Kubica J. Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia. Cardiol J. 2020;27(6):735-741. doi: 10.5603/CJ.a2018.0115. Epub 2018 Sep 24.

  PMID: 30246234 BACKGROUND

• Shin J, Kim J, Song K, Kwak Y. Core temperature measurement in therapeutic hypothermia according to different phases: comparison of bladder, rectal, and tympanic versus pulmonary artery methods. Resuscitation. 2013 Jun;84(6):810-7. doi: 10.1016/j.resuscitation.2012.12.023. Epub 2013 Jan 7.

  PMID: 23306812 BACKGROUND

• Nemeth M, Klose K, Asendorf T, Pancaro C, Mielke B, Fazliu A, Saager L, Brauer A, Miller C. Evaluation of the non-invasive Temple Touch Pro temperature monitoring system compared with oesophageal temperature in paediatric anaesthesia (PETER PAN): A prospective observational study. Eur J Anaesthesiol. 2023 Mar 1;40(3):198-207. doi: 10.1097/EJA.0000000000001796. Epub 2023 Jan 9.

  PMID: 36621856 BACKGROUND

• Nair B. Clinical Trial Designs. Indian Dermatol Online J. 2019 Mar-Apr;10(2):193-201. doi: 10.4103/idoj.IDOJ_475_18. No abstract available.

  PMID: 30984604 BACKGROUND

• Lefrant JY, Muller L, de La Coussaye JE, Benbabaali M, Lebris C, Zeitoun N, Mari C, Saissi G, Ripart J, Eledjam JJ. Temperature measurement in intensive care patients: comparison of urinary bladder, oesophageal, rectal, axillary, and inguinal methods versus pulmonary artery core method. Intensive Care Med. 2003 Mar;29(3):414-8. doi: 10.1007/s00134-002-1619-5. Epub 2003 Feb 8.

  PMID: 12577157 BACKGROUND

• Knapik P, Rychlik W, Duda D, Golyszny R, Borowik D, Ciesla D. Relationship between blood, nasopharyngeal and urinary bladder temperature during intravascular cooling for therapeutic hypothermia after cardiac arrest. Resuscitation. 2012 Feb;83(2):208-12. doi: 10.1016/j.resuscitation.2011.09.001. Epub 2011 Sep 8.

  PMID: 21906572 BACKGROUND

• Hymczak H, Golab A, Mendrala K, Plicner D, Darocha T, Podsiadlo P, Hudziak D, Gocol R, Kosinski S. Core Temperature Measurement-Principles of Correct Measurement, Problems, and Complications. Int J Environ Res Public Health. 2021 Oct 10;18(20):10606. doi: 10.3390/ijerph182010606.

  PMID: 34682351 BACKGROUND

• Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015.

  PMID: 26110027 BACKGROUND

• Fujii T, Takakura M, Taniguchi T, Nishiwaki K. Accuracy of non-invasive core temperature monitoring in infant and toddler patients: a prospective observational study. J Anesth. 2024 Dec;38(6):848-854. doi: 10.1007/s00540-024-03404-7. Epub 2024 Sep 11.

  PMID: 39256231 BACKGROUND

• Evron S, Weissman A, Toivis V, Shahaf DB, You J, Sessler DI, Ezri T. Evaluation of the Temple Touch Pro, a Novel Noninvasive Core-Temperature Monitoring System. Anesth Analg. 2017 Jul;125(1):103-109. doi: 10.1213/ANE.0000000000001695.

  PMID: 28617697 BACKGROUND

• Cox EGM, Dieperink W, Wiersema R, Doesburg F, van der Meulen IC, Paans W. Temporal artery temperature measurements versus bladder temperature in critically ill patients, a prospective observational study. PLoS One. 2020 Nov 6;15(11):e0241846. doi: 10.1371/journal.pone.0241846. eCollection 2020.

  PMID: 33156823 BACKGROUND

• Brauer A, Fazliu A, Brandes IF, Vollnhals F, Grote R, Menzel M. Evaluation of the Temple Touch Pro noninvasive core-temperature monitoring system in 100 adults under general anesthesia: a prospective comparison with esophageal temperature. J Clin Monit Comput. 2023 Feb;37(1):29-36. doi: 10.1007/s10877-022-00851-z. Epub 2022 Apr 4.

  PMID: 35377051 BACKGROUND

• Andreasen TH, Riberholt CG, Fenger AW, Lund A, Vassilieva A, Olsen MH, Moller K. Adverse events registration in clinical trial participants with severe acute brain injury: a Delphi consensus study. Acta Neurochir (Wien). 2025 Dec 22;167(1):332. doi: 10.1007/s00701-025-06724-z.

  PMID: 41428104 BACKGROUND

Related Links

• K150160. (2015, October 20)

Central Study Contacts

Kayla Duvall, MD

CONTACT

414-266-3360; kduvall@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)