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

Обзор

The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.

Подробное описание

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.

Вмешательства

• Устройство Temple Touch Pro
  temporal artery temperature probe

Первичные конечные точки

• Analysis of temperature pairs between TTP and three core locations [Срок оценки: From enrollment to the end of treatment (min. 10 hours)]

Вторичные конечные точки (6)

• Analysis of temperature pairs of bladder and rectal to esophageal temperature recordings [Срок оценки: From enrollment to the end of treatment (min. 10 hours)]
• Analysis of temperature pairs between rectal and bladder [Срок оценки: From enrollment to the end of treatment (min. 10 hours)]
• Analysis of temperature pairs between TTP and three core locations [Срок оценки: From enrollment to 24 hours after targeted temperature management.]
• Analysis of temperature pairs of bladder and rectal to esophageal temperature [Срок оценки: From enrollment to 24 hours after targeted temperature management.]
• Analysis of temperature pairs between rectal and bladder [Срок оценки: From enrollment to 24 hours after targeted temperature management.]
• Difference between the control and experimental (TTP) measurements [Срок оценки: From enrollment to the end of treatment (min. 10 hours)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Wisconsin — Milwaukee

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07507396 · PRO00057443

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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