Temperature MonitoringNCT07507396
Non-invasive Temperature Monitoring in Pediatric Intensive Care Patients Requiring Targeted Temperature Management: Evaluation of Temple Touch Pro
A study testing Temple Touch Pro in people with Temperature Monitoring, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Temperature Monitoring
- What is being tested?
- Temple Touch Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Wisconsin
Milwaukee, Wisconsin, 53222-3840
Melissa McEachern, MA, 414-266-3642, mmceachern@mcw.edu
Kayla Duvall, MD
About this study
The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.
Read the 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.
- Conditions
- Temperature Monitoring
- Being tested
- Temple Touch Pro
- Keywords
- temperature monitoring, Temple Touch Pro, esophageal, rectum, bladder, temporal artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temple Touch ProDevice
temporal artery temperature probe
| Study group | Role | What they receive |
|---|---|---|
| Temple Touch Pro | Active comparator | Not described Receives: Device: Temple Touch Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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.
Measured: 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
Measured: From enrollment to 24 hours after 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 24 hours after targeted temperature management
Measured: From enrollment to 24 hours after targeted temperature management.
Difference between the control and experimental (TTP) measurements
Error grid analysis to determine if difference between the control and experimental measurements would lead to incorrect temperature management.
Measured: From enrollment to the end of treatment (min. 10 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Temperature MonitoringStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- DeRoyal Industries, Inc.
- Responsible party
- Principal investigator, Kayla Duvall, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507396
- Sponsor's protocol ID
- PRO00057443
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30246234Shin 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.
PubMed 23306812Nemeth 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.
PubMed 36621856Nair 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.
PubMed 30984604Lefrant 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.
PubMed 12577157Knapik 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.
PubMed 21906572Hymczak 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.
PubMed 34682351Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015.
PubMed 26110027Fujii 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.
PubMed 39256231Evron 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.
PubMed 28617697Cox 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.
PubMed 33156823Brauer 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.
PubMed 35377051Andreasen 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.
PubMed 41428104
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Temperature Monitoring in Pediatric Intensive Care Patients Requiring Targeted Temperature Management: Evaluation of Temple Touch Pro
- ClinicalTrials.gov ID
- NCT07507396
- Acronym / sponsor ID
- PRO00057443
- Conditions
- Temperature Monitoring
- Keywords
- temperature monitoring, Temple Touch Pro, esophageal, rectum, bladder, temporal artery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- DeRoyal Industries, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temple Touch Pro | Active comparator | Device: Temple Touch Pro |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temple Touch Protemporal artery temperature probe | Device | Temple Touch Pro |
Primary outcome
Analysis of temperature pairs between TTP and three core locations
Time frame: 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
6 secondary outcomes
Analysis of temperature pairs of bladder and rectal to esophageal temperature recordings
Time frame: From enrollment to the end of treatment (min. 10 hours)
Analysis of temperature pairs between rectal and bladder
Time frame: From enrollment to the end of treatment (min. 10 hours)
Analysis of temperature pairs between TTP and three core locations
Time frame: From enrollment to 24 hours after targeted temperature management.
Analysis of temperature pairs of bladder and rectal to esophageal temperature
Time frame: From enrollment to 24 hours after targeted temperature management.
Analysis of temperature pairs between rectal and bladder
Time frame: From enrollment to 24 hours after targeted temperature management.
Difference between the control and experimental (TTP) measurements
Time frame: From enrollment to the end of treatment (min. 10 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 30246234Uminska 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.
- Background: PubMed 23306812Shin 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.
- Background: PubMed 36621856Nemeth 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.
- Background: PubMed 30984604Nair 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.
- Background: PubMed 12577157Lefrant 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.
- Background: PubMed 21906572Knapik 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.
- Background: PubMed 34682351Hymczak 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.
- Background: PubMed 26110027Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015.
- Background: PubMed 39256231Fujii 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.
- Background: PubMed 28617697Evron 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.
- Background: PubMed 33156823Cox 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.
- Background: PubMed 35377051Brauer 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.
- K150160. (2015, October 20)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Temperature Monitoring
Not yet recruiting
Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy
Myeloma
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Not yet recruiting
Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever
Fever, Temperature Monitoring
Recruiting
Moni-Patch Temperature Data Collection for Algorithm Development During Surgery
Body Temperature Monitoring
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temple Touch Pro in people with Temperature Monitoring, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Duvall, MD (414-266-3360, kduvall@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of temperature pairs between TTP and three core locations (time frame: From enrollment to the end of treatment (min. 10 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07507396, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.