Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 2:44 AM
Study NCT ID:
NCT04964232
Status:
UNKNOWN
Last Update Posted:
2021-07-16
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of core-temperature measurements', 'timeFrame': 'Intraoperative period about 1 hour', 'description': 'The accuracy of core-temperature measurements between infrared camera,esophageal probe and skin probe in patients with general anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['core-temperature', 'non-contact temperature measurement'], 'conditions': ['Patients Undergoing General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '7879936', 'type': 'BACKGROUND', 'citation': 'Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.'}, {'pmid': '18931198', 'type': 'BACKGROUND', 'citation': 'Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.'}, {'pmid': '15211129', 'type': 'BACKGROUND', 'citation': 'Wolberg AS, Meng ZH, Monroe DM 3rd, Hoffman M. A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. J Trauma. 2004 Jun;56(6):1221-8. doi: 10.1097/01.ta.0000064328.97941.fc.'}, {'pmid': '140451', 'type': 'BACKGROUND', 'citation': 'Boggan WO, Meyer JS. Effects of serotonergic drugs on methaqualone-induced hypothermia. Res Commun Chem Pathol Pharmacol. 1977 Apr;16(4):629-36.'}, {'pmid': '18431110', 'type': 'BACKGROUND', 'citation': 'Langesaeter E. Is it more informative to focus on cardiac output than blood pressure during spinal anesthesia for cesarean delivery in women with severe preeclampsia? Anesthesiology. 2008 May;108(5):771-2. doi: 10.1097/ALN.0b013e31816bbe04. No abstract available.'}, {'pmid': '18156884', 'type': 'BACKGROUND', 'citation': 'Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.'}, {'pmid': '28198959', 'type': 'BACKGROUND', 'citation': 'Poveda VB, Nascimento AS. Intraoperative body temperature control: esophageal thermometer versus infrared tympanic thermometer. Rev Esc Enferm USP. 2016 Nov-Dec;50(6):946-952. doi: 10.1590/S0080-623420160000700010. English, Portuguese.'}, {'pmid': '12972820', 'type': 'BACKGROUND', 'citation': 'Callanan D. Detecting fever in young infants: reliability of perceived, pacifier, and temporal artery temperatures in infants younger than 3 months of age. Pediatr Emerg Care. 2003 Aug;19(4):240-3. doi: 10.1097/01.pec.0000086231.54586.15.'}, {'pmid': '1739325', 'type': 'BACKGROUND', 'citation': 'Morley CJ, Hewson PH, Thornton AJ, Cole TJ. Axillary and rectal temperature measurements in infants. Arch Dis Child. 1992 Jan;67(1):122-5. doi: 10.1136/adc.67.1.122.'}, {'pmid': '1984726', 'type': 'BACKGROUND', 'citation': 'Muma BK, Treloar DJ, Wurmlinger K, Peterson E, Vitae A. Comparison of rectal, axillary, and tympanic membrane temperatures in infants and young children. Ann Emerg Med. 1991 Jan;20(1):41-4. doi: 10.1016/s0196-0644(05)81116-3.'}, {'pmid': '10735803', 'type': 'BACKGROUND', 'citation': 'Cattaneo CG, Frank SM, Hesel TW, El-Rahmany HK, Kim LJ, Tran KM. The accuracy and precision of body temperature monitoring methods during regional and general anesthesia. Anesth Analg. 2000 Apr;90(4):938-45. doi: 10.1097/00000539-200004000-00030.'}, {'pmid': '12410196', 'type': 'BACKGROUND', 'citation': 'Jean-Mary MB, Dicanzio J, Shaw J, Bernstein HH. Limited accuracy and reliability of infrared axillary and aural thermometers in a pediatric outpatient population. J Pediatr. 2002 Nov;141(5):671-6. doi: 10.1067/mpd.2002.127664.'}, {'pmid': '32294973', 'type': 'BACKGROUND', 'citation': 'Negishi T, Abe S, Matsui T, Liu H, Kurosawa M, Kirimoto T, Sun G. Contactless Vital Signs Measurement System Using RGB-Thermal Image Sensors and Its Clinical Screening Test on Patients with Seasonal Influenza. Sensors (Basel). 2020 Apr 13;20(8):2171. doi: 10.3390/s20082171.'}]}, 'descriptionModule': {'briefSummary': '"A method of monitoring body temperature during surgery is to measure esophageal temperature using a catheter. Although this method is known as a method to accurately measure core temperature, it is not recommended for local anesthesia patients and requires an invasive procedure that can be used to monitor body temperature non-invasive as it may feel uncomfortable during placement and maintenance management. Various methods have been developed to measure body temperature noninvasive, such as in the mouth, armpits, skin surfaces, and aural canals. However, developed methods can also cause discomfort to patients in that they attach sensors to their skin.\n\nIn this study, we use the esophageal temperature measurement method, the skin contact temperature measurement method, and the IR contactless temperature measurement method to simultaneously measure body temperature and to compare the accuracy of body temperature measurement according to each method."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. An adult who underwent endoscopic/laparotomy Hepatectomy of living donor, Pylorus preserving pancreaticoduodenectomy, Renal allograft, Flexible ureterorenoscopic removal of calculus of upper ureter with regular surgery\n\nExclusion Criteria:\n\n1\\. Subjects at risk of bleeding due to esophageal probe, and past cranial, esophageal varicose veins surgery.'}, 'identificationModule': {'nctId': 'NCT04964232', 'briefTitle': 'Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures', 'orgStudyIdInfo': {'id': '1-2020-0083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temperature monitoring group', 'description': 'The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera.', 'interventionNames': ['Device: Infrared Camera', 'Device: Esophageal Temperature Probe', 'Device: Skin temperature probe']}], 'interventions': [{'name': 'Infrared Camera', 'type': 'DEVICE', 'description': 'The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera.', 'armGroupLabels': ['Temperature monitoring group']}, {'name': 'Esophageal Temperature Probe', 'type': 'DEVICE', 'description': 'In patients undergoing general anesthesia, the Esophageal temeperature parameters are measured using an Esophageal probe.', 'armGroupLabels': ['Temperature monitoring group']}, {'name': 'Skin temperature probe', 'type': 'DEVICE', 'description': 'In patients undergoing general anesthesia, the skin spot temeperature parameters are measured using an skin adhesive probe.', 'armGroupLabels': ['Temperature monitoring group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeongmin Kim', 'role': 'CONTACT', 'email': 'ANESJEONGMIN@yuhs.ac', 'phone': '+82 10-8926-2684'}], 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jeongmin Kim', 'role': 'CONTACT', 'email': 'ANESJEONGMIN@yuhs.ac', 'phone': '+82 10-8926-2684'}], 'overallOfficials': [{'name': 'Jeongmin Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital, Yonsei University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}