Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:49 AM
Study NCT ID:
NCT07352202
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Gastric Emptying in Mechanically Ventilated ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gastric Volume Estimated by Ultrasound', 'timeFrame': 'Baseline and up to 60 minutes after enteral feeding', 'description': 'Dynamic changes in gastric volume estimated using ultrasound-derived antral cross-sectional area measurements at predefined time points before and after enteral feeding.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric ultrasound', 'ıntensive care unit', 'gastric residual volume'], 'conditions': ['Gastric Ultrasound']}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate dynamic changes in gastric volume and gastric emptying time using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. The study compares gastric emptying patterns among patients receiving different types of enteral nutrition solutions as part of routine clinical care.', 'detailedDescription': 'This prospective observational study is designed to evaluate gastric emptying and changes in gastric volume using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. Ultrasound examinations will be performed at predefined time points to assess gastric residual volume and gastric emptying patterns.\n\nPatients receiving different types of enteral nutrition solutions as part of routine clinical care will be evaluated and compared. Gastric measurements will be obtained using standardized ultrasound techniques by trained clinicians.\n\nThe study aims to identify differences in gastric emptying dynamics associated with various enteral nutrition formulations and to assess the feasibility of bedside ultrasound as a non-invasive tool for monitoring gastric function in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients aged 18 years and older who are mechanically ventilated and admitted to the intensive care unit. Eligible patients are those receiving enteral nutrition via a nasogastric tube as part of routine clinical care and who are hemodynamically stable. Patients will be observed prospectively without any protocol-driven intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Mechanically ventilated patients admitted to the intensive care unit\n* Presence of a nasogastric tube\n* Hemodynamically stable patients receiving enteral nutrition as part of routine clinical care\n\nExclusion Criteria:\n\n* Recent abdominal surgery within the first 24 hours\n* Major abdominal trauma or burns\n* Significant ascites\n* Inadequate ultrasound window (e.g., severe meteorism)\n* Hemodynamic instability\n* Contraindication to enteral nutrition'}, 'identificationModule': {'nctId': 'NCT07352202', 'acronym': 'GASTRIC-USG', 'briefTitle': 'Ultrasound Assessment of Gastric Emptying in Mechanically Ventilated ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}, 'officialTitle': 'Evaluation of Gastric Emptying and Residual Volume Using Ultrasound in Mechanically Ventilated Intensive Care Patients Receiving Different Enteral Nutrition Solutions', 'orgStudyIdInfo': {'id': '2025-395'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard Enteral Nutrition', 'description': 'Mechanically ventilated intensive care unit patients receiving standard enteral nutrition as part of routine clinical care.', 'interventionNames': ['Other: Enteral Nutrition (Routine Clinical Care)']}, {'label': 'Specialized Enteral Nutrition', 'description': 'Mechanically ventilated intensive care unit patients receiving specialized enteral nutrition formulations according to routine clinical practice.', 'interventionNames': ['Other: Enteral Nutrition (Routine Clinical Care)']}, {'label': 'Water Administration', 'description': 'Mechanically ventilated intensive care unit patients receiving water administration via nasogastric tube as part of routine care.', 'interventionNames': ['Other: Enteral Nutrition (Routine Clinical Care)']}], 'interventions': [{'name': 'Enteral Nutrition (Routine Clinical Care)', 'type': 'OTHER', 'description': 'Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.', 'armGroupLabels': ['Specialized Enteral Nutrition', 'Standard Enteral Nutrition', 'Water Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra Adıyeke, MD', 'role': 'CONTACT', 'email': 'berfinozelsel@gmail.com', 'phone': '05421104082'}], 'facility': 'Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Berfin Gizem G Ozelsel, MD', 'role': 'CONTACT', 'email': 'berfingizemuslu@hotmail.com', 'phone': '+905421104082'}, {'name': 'Şule Altuncu, MD', 'role': 'CONTACT', 'email': 'sule.621@hotmail.com', 'phone': '+905370263100'}], 'overallOfficials': [{'name': 'Berfin Gizem G Özelsel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional data protection policies and the inclusion of critically ill patients. Data will be analyzed and reported in an aggregated and anonymized manner.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}