Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-02 @ 1:28 AM
Study NCT ID:
NCT03685435
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High risk of aspiration', 'timeFrame': 'Immediately before intubation', 'description': 'Detection of solids, or more than 1,5 mL/kg clear fluid in the gaster'}, {'measure': 'Low risk of aspiration', 'timeFrame': 'Immediately before intubation', 'description': 'Detection of empty stomach, or less than 1,5 mL/kg clear fluid in the gaster'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Gastric content', 'Non-fasting', 'Rapid Sequence Induction', 'Gastric volume'], 'conditions': ['Non-fasting Patients', 'Rapid Sequence Intubation', 'Anesthesia Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Using bedside ultrasound, the investigators will examine gastric content in non-fasting patients assigned to rapid sequence intubation (RSI). The procedure will be done immediately before intubation. The percentage of non-fasting patients who actually have gastric content will be determined.\n\nIdentifying gastric content is critical because presence increases the risk of pulmonary aspiration during intubation.', 'detailedDescription': 'Quantitative gastric content will be registered by measuring the cross section area of antrum using bedside ultrasound. The area and the patients age will be applied to estimate gastric volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are assigned to rapid sequence intubation are considered non-fasting. Reasons for considering a patient non-fasting are among others: intake of food the last six hours, nausea, anxiety, preoperative intake of painkillers or reflux disease.\n\nThe ultrasound method we are using, are only valid for this specific population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults scheduled for surgery\n* Adults over 18 years old that are assigned to general anesthesia with rapid sequence intubation (RSI)\n\nExclusion Criteria:\n\n* Body mass index over 40\n* Pregnant women\n* Patients earlier underwent gastric surgery\n* Critically ill patients where spending time on ultrasound would cause a major disadvantage for the patients'}, 'identificationModule': {'nctId': 'NCT03685435', 'briefTitle': 'Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Preoperative Presence of Gastric Content in Non-fasting Patients - an Ultrasound Study', 'orgStudyIdInfo': {'id': '2018/1560'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-fasting patients', 'description': 'We will examine non-fasting patients using bedside ultrasound. First we examine the gaster in a supine position. Then we repeat the procedure in a right lateral position.', 'interventionNames': ['Other: Bedside ultrasound']}], 'interventions': [{'name': 'Bedside ultrasound', 'type': 'OTHER', 'description': 'Checking for gastric content using bedside ultrasound', 'armGroupLabels': ['Non-fasting patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lørenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Akershus University Hospital'}], 'overallOfficials': [{'name': 'Vegard Dahl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have not planned to share data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor 2', 'investigatorFullName': 'Vegard Dahl', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}