Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-02 @ 11:26 AM
Study NCT ID:
NCT04288466
Status:
UNKNOWN
Last Update Posted:
2020-02-28
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Emptying of Maltodextrin Solution in Elderly and in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antral Volume change', 'timeFrame': 'Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)', 'description': 'Antral volume in cm² assessed by ultrasound in semirecumbent position.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aspiration; Liquids', 'Fasting', 'Perioperative Pulmonary Aspiration']}, 'descriptionModule': {'briefSummary': 'Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.', 'detailedDescription': 'Gastric volume will be estimated before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly using antral ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I or II;\n* No known risk factor for slow or fast gastric emptying.\n\nExclusion Criteria:\n\n* Vomiting the study solution before completion.\n* Wrong timing of assessment.\n* Protocol violation.'}, 'identificationModule': {'nctId': 'NCT04288466', 'acronym': 'GEMA', 'briefTitle': 'Gastric Emptying of Maltodextrin Solution in Elderly and in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia University Hospital'}, 'officialTitle': 'Gastric Emptying of Maltodextrin Solution in Elderly and in Adults: Clinical Trial', 'orgStudyIdInfo': {'id': 'tccandre2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adults', 'description': 'Adults \\< 60 years-old maltodextrin solution 450ml', 'interventionNames': ['Dietary Supplement: maltodextrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elders', 'description': 'Elders 65 or more years-old maltodextrin solution 450ml', 'interventionNames': ['Dietary Supplement: maltodextrin']}], 'interventions': [{'name': 'maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'maltodextrin solution 450ml', 'armGroupLabels': ['Adults', 'Elders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000000', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital das Forças armadas', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Gabriel MN Guimaraes, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'We will put SAP and Analytic code in RPubs for as long as RPubs exists. Study protocol and ICF will be published in ClinicalTrials', 'ipdSharing': 'YES', 'description': 'Plan to Share in Online Data Sharing Platform.', 'accessCriteria': 'Open'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Gabriel Magalhaes Nunes Guimaraes', 'investigatorAffiliation': 'Brasilia University Hospital'}}}}