[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07507396":3,"trial-entities:NCT07507396":139,"trial-summary:NCT07507396":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":38,"secondary_outcomes":43,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":68,"locations":70,"central_contacts":89,"overall_officials":93,"references":94,"see_also_links":135},"NCT07507396","PRO00057443","Non-invasive Temperature Monitoring in Pediatric Intensive Care Patients Requiring Targeted Temperature Management: Evaluation of Temple Touch Pro","NOT_YET_RECRUITING","2027-05","2026-03","2026-04-02","2026-05","Medical College of Wisconsin","OTHER",false,"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\u002For rectum.\n\nBoth 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.",[18],"Temperature Monitoring",[20,21,22,23,24,25],"temperature monitoring","Temple Touch Pro","esophageal","rectum","bladder","temporal artery","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},20,"ESTIMATED",[34],{"type":35,"name":21,"description":36,"armGroupLabels":37},"DEVICE","temporal artery temperature probe",[21],[39],{"measure":40,"description":41,"timeFrame":42},"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)",[44,47,50,53,56,58],{"measure":45,"description":46,"timeFrame":42},"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",{"measure":48,"description":49,"timeFrame":42},"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",{"measure":40,"description":51,"timeFrame":52},"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.",{"measure":54,"description":55,"timeFrame":52},"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",{"measure":48,"description":57,"timeFrame":52},"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",{"measure":59,"description":60,"timeFrame":42},"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.","ALL","0 Years","17 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Age 0 to less than 18 years of age\n2. PICU Diagnosis requiring targeted temperature management. For example traumatic brain injury, cardiac arrest, or anoxic brain injury\n3. Requires continuous temperature monitoring with a foley catheter (bladder) or a general purpose probe placed in the esophagus.\n4. Enrolled within 24 hours of start of continuous temperature monitoring.\n5. Patient has adequate forehead space to accommodate the TTP sensor\n6. Temporal artery perfusion not compromised by injury or other pathology\n7. No surgical procedure planned for 72 hours\n8. Targeted temperature management expected for at least 24 hours at time of consent\n\nExclusion Criteria:\n\n1. Already enrolled in another trial addressing temperature management\n2. Allergy to medical grade acrylic adhesive\n3. Patient does not tolerate placement of TTP sensor on forehead\n4. Contraindication to the placement of two or more of Foley, esophageal, and rectal temperature probes.\n5. A history of skin irritation, skin sensitivity, or skin disease, including psoriasis, eczema, atopic dermatitis, and skin cancer.\n6. Pregnant or lactating female",[69],"CHILD",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":86},"Children's Wisconsin","Milwaukee","Wisconsin","53222-3840","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Melissa McEachern, MA","CONTACT","414-266-3642","mmceachern@mcw.edu",{"name":84,"role":85},"Kayla Duvall, MD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},43.0389,-87.90647,[90],{"name":84,"role":80,"phone":91,"email":92},"414-266-3360","kduvall@mcw.edu",[],[95,99,102,105,108,111,114,117,120,123,126,129,132],{"pmid":96,"type":97,"citation":98},"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\u002FCJ.a2018.0115. Epub 2018 Sep 24.",{"pmid":100,"type":97,"citation":101},"23306812","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\u002Fj.resuscitation.2012.12.023. Epub 2013 Jan 7.",{"pmid":103,"type":97,"citation":104},"36621856","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\u002FEJA.0000000000001796. Epub 2023 Jan 9.",{"pmid":106,"type":97,"citation":107},"30984604","Nair B. Clinical Trial Designs. Indian Dermatol Online J. 2019 Mar-Apr;10(2):193-201. doi: 10.4103\u002Fidoj.IDOJ_475_18. No abstract available.",{"pmid":109,"type":97,"citation":110},"12577157","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\u002Fs00134-002-1619-5. Epub 2003 Feb 8.",{"pmid":112,"type":97,"citation":113},"21906572","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\u002Fj.resuscitation.2011.09.001. Epub 2011 Sep 8.",{"pmid":115,"type":97,"citation":116},"34682351","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\u002Fijerph182010606.",{"pmid":118,"type":97,"citation":119},"26110027","Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613\u002FBM.2015.015. eCollection 2015.",{"pmid":121,"type":97,"citation":122},"39256231","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\u002Fs00540-024-03404-7. Epub 2024 Sep 11.",{"pmid":124,"type":97,"citation":125},"28617697","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\u002FANE.0000000000001695.",{"pmid":127,"type":97,"citation":128},"33156823","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\u002Fjournal.pone.0241846. eCollection 2020.",{"pmid":130,"type":97,"citation":131},"35377051","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\u002Fs10877-022-00851-z. Epub 2022 Apr 4.",{"pmid":133,"type":97,"citation":134},"41428104","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\u002Fs00701-025-06724-z.",[136],{"label":137,"url":138},"K150160. (2015, October 20)","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fcdrh_docs\u002Fpdf15\u002FK150160.pdf",{"nct_id":4,"conditions":140,"biomarkers":144},[141,142,143],"Anoxic encephalopathy","Cardiac Arrest","Traumatic Encephalopathy",[],{"nct_id":4,"found":146,"summary":147,"prompt_version":157},true,{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is an interventional study evaluating a device in about 20 participants. It compares the Temple Touch Pro to existing temperature monitoring methods.","completed","Evaluating Temple Touch Pro for Temperature Monitoring in Pediatric ICU Patients","This study is looking at a new way to measure temperature in children in the intensive care unit (PICU) who need their body temperature carefully controlled. It's testing a device called Temple Touch Pro (TTP), which measures temperature from the skin on the forehead. Currently, these children often need tubes placed in their bladder or esophagus for continuous temperature monitoring, which can have risks. This study will add the Temple Touch Pro as a third way to measure temperature alongside these existing methods. The goal is to see how well the Temple Touch Pro's readings match the temperatures from the bladder or esophagus. Children aged 0 to 17 years who are in the PICU and need continuous temperature monitoring for conditions like brain injury or cardiac arrest can join. The study aims to enroll 20 patients, but its current recruitment status is unclear.","Temperature readings will be collected from enrollment to the end of treatment, for a minimum of 10 hours.",143,"You would have the Temple Touch Pro device added as a third temperature monitoring method. This monitoring would continue from enrollment until the end of treatment, for a minimum of 10 hours.","Not stated in the trial record.",[21],"v2"]