Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 9:24 AM
Study NCT ID:
NCT05478850
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D008305', 'term': 'Malignant Hyperthermia'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D000084462', 'term': 'Hyperthermia'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-09', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body temperature change among 2 time period', 'timeFrame': 'time from before radiotherapy to the end of radiotherapy', 'description': 'non-contact body temperature measured on forehead'}, {'measure': 'recovery time from anesthesia', 'timeFrame': 'the time from end of radiotherapy to discharging', 'description': 'Time from the end of the procedure until the Modified Steward score ≥ 8 in the patient recovery room'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothermia; Anesthesia', 'Hyperthermia, Anesthesia Related', 'Radiotherapy Side Effect', 'Childhood Cancer'], 'conditions': ['Hypothermia; Anesthesia', 'Hyperthermia, Anesthesia Related', 'Radiotherapy Side Effect', 'Childhood Cancer']}, 'descriptionModule': {'briefSummary': 'In prospective, observational cohort study, changes in body temperature will be investigated before the procedure and during recovery in Radiotherapy patients aged 0-18 years who need sedation due to childhood malignancies.\n\nThe aims of this study were to measure the incidence and magnitude of changes in body temperature in children undergoing sedation or general anesthesia for Radiotherapy, and to determine their effects on the recovery process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing radiotherapy under anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing radiotherapy under anesthesia\n\nExclusion Criteria:\n\n* family refusal to participate,\n* chronic nausea and vomiting complaints,\n* active infection,\n* apnea history,\n* cardiac disease, kidney and liver failure,\n* anomalies that may cause difficult airway,\n* metabolic diseases,\n* neurological or muscular diseases.'}, 'identificationModule': {'nctId': 'NCT05478850', 'briefTitle': 'Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia', 'orgStudyIdInfo': {'id': 'E1-22-2700'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiotherapy under anesthesia', 'interventionNames': ['Procedure: radiotherapy under anesthesia']}], 'interventions': [{'name': 'radiotherapy under anesthesia', 'type': 'PROCEDURE', 'description': 'Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.', 'armGroupLabels': ['Radiotherapy under anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Betül Güven Aytaç, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Betül Güven', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}