Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-27 @ 1:34 PM
Study NCT ID:
NCT07455695
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2026-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'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': 285}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Temperature (ΔT) Before and After MRI', 'timeFrame': 'From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)', 'description': 'The difference between tympanic body temperature measured immediately before sedation and immediately after completion of MRI (post-MRI minus pre-MRI temperature), expressed in degrees Celsius (°C).'}], 'secondaryOutcomes': [{'measure': 'Change in Tympanic Body Temperature (ΔT)', 'timeFrame': 'From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).', 'description': 'Change in core body temperature measured at the tympanic membrane using a Braun Thermoscan Ear Thermometer PRO 6000 (accuracy ±0.2°C). ΔT is calculated as post-MRI temperature minus pre-MRI temperature.\n\nUnit of Measure: Degrees Celsius (°C)'}, {'measure': 'Regression Coefficient (B) for Continuous Body Temperature Change (ΔT, °C)', 'timeFrame': 'From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)', 'description': 'Independent predictors of continuous body temperature change (ΔT, °C) will be evaluated using multivariable linear regression analysis. In this model, ΔT (calculated as post-MRI minus pre-MRI tympanic temperature) will be entered as the dependent variable. The following predefined variables will be included simultaneously as independent predictors: age group (0-2, 3-7, 8-17 years), sex (male/female), ASA physical status (I-III), body mass index (kg/m²), fasting duration (hours), MRI duration (minutes), MRI room temperature (°C), MRI room humidity (%), contrast administration (yes/no), presence of comorbidity (yes/no), malignancy (yes/no), and allergy history (yes/no).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Anesthesia', 'Sedation', 'Magnetic Resonance Imaging', 'Body Temperature Changes', 'Pediatric Patients'], 'conditions': ['Body Temperature Changes', 'Pediatric Anesthesia', 'Magnetic Resonance Imaging']}, 'descriptionModule': {'briefSummary': 'Magnetic resonance imaging (MRI) is widely used in pediatric patients and frequently requires sedation or general anesthesia. Both sedation and MRI-related environmental factors may influence thermoregulation. This prospective observational study aimed to evaluate body temperature changes in children undergoing MRI under sedation and to identify factors associated with these changes. A total of 285 pediatric patients (ASA physical status I-III) were included. Tympanic body temperature was measured immediately before sedation and after completion of MRI, and the temperature difference (ΔT) was calculated. Demographic, clinical, and environmental variables were analyzed to determine predictors of temperature change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients younger than 18 years with ASA physical status I-III undergoing magnetic resonance imaging (MRI) under sedation between November 2023 and April 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\<18 years.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Scheduled to undergo clinically indicated magnetic resonance imaging (MRI) under sedation.\n* Written informed consent obtained from parent.\n\nExclusion Criteria:\n\n* Age ≥18 years.\n* ASA physical status IV-V.\n* Known allergy to anesthetic medications used for sedation.\n* Unstable vital signs prior to MRI.\n* Fever (body temperature ≥37.5°C) before MRI.\n* Severe pulmonary or cardiovascular comorbidities.\n* Requirement for advanced airway management (laryngeal mask airway or endotracheal intubation).\n* Refusal or absence of parental consent.'}, 'identificationModule': {'nctId': 'NCT07455695', 'briefTitle': 'Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation', 'orgStudyIdInfo': {'id': 'AEŞH-EK1-2023-555'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sedation During MRI', 'type': 'OTHER', 'description': 'This is a prospective observational study. No experimental intervention was applied. All pediatric patients underwent routine sedation for clinically indicated MRI procedures according to institutional standard practice. The study evaluated body temperature changes before and after MRI without modifying clinical management.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Altındağ', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.96673, 'lon': 32.92254}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Ahmet Murat Gul', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}