Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 11:48 AM
Study NCT ID:
NCT06010069
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2023-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of hypothermia', 'timeFrame': 'during the orthopedic surgical procedure', 'description': 'difference between frailty groups in terms of frequency of hypothermia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia; Anesthesia', 'Fragility']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare frequency of intraoperative hypothermia between fragilitly groups of eldery patients who underwent orthopedic surgical procedures.\n\nIt aims to answer those questions:\n\n* İs there any difference between fragility groups in terms of hypothermia frequency during orthopedic surgical procedures?\n* Are there any other factors that influence the frequency of hypothermia such as age, body mass index, room temperature etc. ? Participants body temperature before anestesia application,and before surgery had started was measured and measurament was done during whole procedure. Measuraments had been done by tympanic thermometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our candidates was choosen from patiens who scheduled for elective orthopedic surgeries in Kirsehir education and research hospital. We have enrolled patients who accepted to be a partician for this study after obtaining their informed consent. Elective Orthopedic Surgery. All of our participants were 65 years old or older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective Orthopedic Surgery Candidates\n* 65 years old or older\n\nExclusion Criteria:\n\n* Emergency surgery\n* Patiens who required multiple (2 or more) blood component transfusions\n* Neurologic disorders\n* tyroid dysfunction\n* Patiens who are already hypothermic before surgery'}, 'identificationModule': {'nctId': 'NCT06010069', 'briefTitle': 'The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores in the Elderly Patient Group. Prospective Cohort Study', 'orgStudyIdInfo': {'id': '22.11.2022 No: 2022-21/187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-frail patients', 'description': 'That patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail.', 'interventionNames': ['Diagnostic Test: body temperature measurament']}, {'label': 'frail patients', 'description': 'That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail.', 'interventionNames': ['Diagnostic Test: body temperature measurament']}, {'label': 'very frail patients', 'description': 'That patient group have clinical frailty scale scores 6,7,8 or 9 which is accepted as severly frail.', 'interventionNames': ['Diagnostic Test: body temperature measurament']}], 'interventions': [{'name': 'body temperature measurament', 'type': 'DIAGNOSTIC_TEST', 'description': 'body temperature of every patient was measured with tympanic thermometer during surgical procedure', 'armGroupLabels': ['frail patients', 'pre-frail patients', 'very frail patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04100', 'city': 'Kırşehir', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Kırşehir Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After the statistical analyzes we will most likely to share IPDs'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Docdor', 'investigatorFullName': 'Fatma Nur Arslan', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}