Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 3:58 AM
Study NCT ID:
NCT05695066
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063466', 'term': 'Respiratory Aspiration of Gastric Contents'}], 'ancestors': [{'id': 'D057045', 'term': 'Laryngopharyngeal Reflux'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSA', 'timeFrame': 'Immediately before anesthesia induction', 'description': 'Gastric antral surface area'}], 'secondaryOutcomes': [{'measure': 'Suctioned GCV', 'timeFrame': 'Immediately after intubation', 'description': 'Gastric content volume suctioned through nasogastric tube after induction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperation fasting', 'Anaesthesia', 'Children', 'Enteral feeding'], 'conditions': ['Pulmonary Aspiration of Gastric Contents']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/34857683/', 'label': 'Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30095551/', 'label': 'Ultrasound assessment of gastric emptying time after a standardised light breakfast in healthy children: A prospective observational study.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31608517/', 'label': 'Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.', 'detailedDescription': 'Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.\n\nEnteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChild on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia\n\nExclusion Criteria:\n\nModerate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier'}, 'identificationModule': {'nctId': 'NCT05695066', 'acronym': 'ENGUS', 'briefTitle': 'Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound', 'orgStudyIdInfo': {'id': 'ENGUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4H group', 'description': 'Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction', 'interventionNames': ['Procedure: Preoperative fasting instruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6H group', 'description': 'Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction', 'interventionNames': ['Procedure: Preoperative fasting instruction']}], 'interventions': [{'name': 'Preoperative fasting instruction', 'type': 'PROCEDURE', 'description': 'Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction', 'armGroupLabels': ['4H group', '6H group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Peter Frykholm, MD PhD', 'role': 'CONTACT', 'email': 'peter.frykholm@surgsci.uu.se', 'phone': '+46708454969'}, {'name': 'Ali Modiri, PhD', 'role': 'CONTACT', 'email': 'alireza.modiri@akademiska.se', 'phone': '+467411410'}], 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Peter Frykholm, MD, PhD', 'role': 'CONTACT', 'email': 'peter.frykholm@surgsci.uu.se', 'phone': '+46186171240'}, {'name': 'Ali-Reza Modiri, PhD', 'role': 'CONTACT', 'email': 'ali-reza.modiri@uu.se', 'phone': '+46727411410'}], 'overallOfficials': [{'name': 'Peter Frykholm, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Peter Frykholm', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}