Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-29 @ 3:42 AM
Study NCT ID:
NCT03477357
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Non-contact Thermometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core body temperature measurement will be taken from 30 patients to compare non-contact infra-red thermometer to oesophageal temperature probes', 'timeFrame': '12 months', 'description': 'Bland Altman analysis to compare the readings of 2 methods of temperature measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': 'Subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon they will undergo standard admission processes, including pre-operative assessment by the anaesthetist assigned to that list (One of the two study authors). The anaesthetist will then explain the study again, reiterating the potential risks and benefits of the study to the patient themselves, and to the population as a whole. Consent will be sought at this point.\n\nPatients will be transferred to theatre, anaesthetised and operated on as per normal practice. Inclusive of this, in accordance with NICE guidelines, patients will have a nasal or oesophageal Doppler probe inserted to accurately measure core temperature. At this point, patients enrolled in the study will have temperature measurements taken every minute from the oesophageal probe and non-contact thermometers.\n\nIf the patients requested it previously, they will be informed of the results of the study at a later date.\n\nStatistics will then be carried out on the data to compare accuracy of the two novel methods to the oesophageal probe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assesment clinic as part of their normal work up for theatre', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre.\n\nExclusion Criteria:\n\n\\- Lacking mental capacity Not speaking English Malignancy in medical history Undergoing open abdominal surgery'}, 'identificationModule': {'nctId': 'NCT03477357', 'briefTitle': 'Accuracy of Non-contact Thermometry', 'organization': {'class': 'OTHER', 'fullName': 'Brighton and Sussex University Hospitals NHS Trust'}, 'officialTitle': 'A Study to Determine the Accuracy of a Non-contact Thermometer in the Perioperative Setting', 'orgStudyIdInfo': {'id': '214661'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Geratherm non Contact thermometer', 'type': 'DEVICE', 'description': 'Temperature taken from subject using non-contact device as per manufacturers instructions'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TN62DS', 'city': 'Brighton', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Brighton and Sussex University Hospitals NHS Trust', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}], 'overallOfficials': [{'name': 'Jack Reid, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BSUH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be anonymised and analysed later.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brighton and Sussex University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}