Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-18 @ 12:41 PM
Study NCT ID:
NCT04664751
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2020-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compliance to NPO guideline', 'timeFrame': '8 hour', 'description': 'definition of compliance include complete order of NPO for regular diet for 8 hours and soft diet for 6 hours and clear liquid for 2 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Compliance', 'NPO guidelines'], 'conditions': ['Compliance, Treatment']}, 'descriptionModule': {'briefSummary': 'Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having\n\n* clear liquid drink\n* light meal\n* regular meal'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia.\n\nExclusion Criteria:\n\n* Patients with the order of NPO after midnight.\n* Patients with pregnancy'}, 'identificationModule': {'nctId': 'NCT04664751', 'briefTitle': 'Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective General Surgery.', 'orgStudyIdInfo': {'id': '997/2563(IRB2)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients scheduled for general surgery with anesthesia', 'description': 'Patients scheduled for general surgery with anesthesia, receiving Nil-per-Oral order.', 'interventionNames': ['Other: Nil-per-Oral']}], 'interventions': [{'name': 'Nil-per-Oral', 'type': 'OTHER', 'description': 'NPO details', 'armGroupLabels': ['Patients scheduled for general surgery with anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sirilak Suksompong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sirilak Suksompong', 'investigatorAffiliation': 'Mahidol University'}}}}