Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 5:13 AM
Study NCT ID:
NCT05810532
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NPO Before Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric astral cross-sectional area', 'timeFrame': '10 minutes before sedation', 'description': 'Gastric astral cross-sectional area measured with gastric ultrasound'}], 'secondaryOutcomes': [{'measure': 'Estimated gastric volume', 'timeFrame': '10 minutes before sedation', 'description': 'Calculated gastric volume using the formula'}, {'measure': 'Perlas grade', 'timeFrame': '10 minutes before sedation', 'description': 'Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration'}, {'measure': 'Quality of sdeation', 'timeFrame': '10 minutes after sedation', 'description': '0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric ALL']}, 'referencesModule': {'references': [{'pmid': '40530767', 'type': 'DERIVED', 'citation': 'Cho E, Song J, Huh J, Kang IS, Kim HJ, Youn IY, Lee H, Kwak JH. Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial. Paediatr Anaesth. 2025 Sep;35(9):753-760. doi: 10.1111/pan.15142. Epub 2025 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.\n\nTherefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children scheduled for elective echocardiography\n* Aged under 3 years old\n\nExclusion Criteria:\n\n* Comorbidity other than hear disease or chromosomal disease\n* Patients with delayed gastric emptying\n* Patients with structural abnormalities of the stomach or esophagus\n* Difficult airway management\n* Parents refuse to participate in the study\n* Unable to achieve sedation\n* Neonatal'}, 'identificationModule': {'nctId': 'NCT05810532', 'briefTitle': 'NPO Before Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.', 'orgStudyIdInfo': {'id': 'NPO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4H group', 'description': 'fasting more than 4 hours before sedation', 'interventionNames': ['Other: 4 hours of fasting time']}, {'type': 'EXPERIMENTAL', 'label': '1H group', 'description': 'oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation', 'interventionNames': ['Other: 1 hour of fasting time']}], 'interventions': [{'name': '4 hours of fasting time', 'type': 'OTHER', 'description': 'Oral intake is not allowed for 4 hours before sedation including water', 'armGroupLabels': ['4H group']}, {'name': '1 hour of fasting time', 'type': 'OTHER', 'description': 'Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation', 'armGroupLabels': ['1H group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eunah Cho, MD', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}