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| Name | Class |
|---|---|
| DeRoyal Industries, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temple Touch Pro | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temple Touch Pro | Device | temporal artery temperature probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment (min. 10 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Duvall, MD | Contact | 414-266-3360 | kduvall@mcw.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Wisconsin | Milwaukee | Wisconsin | 53222-3840 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30246234 | Background | 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. | |
| 23306812 |
| Label | URL |
|---|---|
| K150160. (2015, October 20) | View source |
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| 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 |
| 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. | 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 | 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 | 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. | From enrollment to the end of treatment (min. 10 hours) |
| 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. |
| 36621856 | 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. |
| 30984604 | 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. |
| 12577157 | 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. |
| 21906572 | 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. |
| 34682351 | 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. |
| 26110027 | 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. |
| 39256231 | 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. |
| 28617697 | 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. |
| 33156823 | 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. |
| 35377051 | 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. |
| 41428104 | 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. |