Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT03017066
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Preoperative Gastric Volume in Children
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': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-group difference between gastric volume measured on second and third ultrasound assessment', 'timeFrame': 'Interval between second and third ultrasound assessment, an expected average of 1 hour'}], 'secondaryOutcomes': [{'measure': 'Inter-group difference in gastric volume at each time point', 'timeFrame': 'From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours'}, {'measure': 'Perioperative incidence of nausea, vomiting, fever, and respiratory complications', 'timeFrame': 'From the induction of general anesthesia until postoperative 24 hours'}, {'measure': "Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}, {'measure': "Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}, {'measure': "Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}, {'measure': "Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}, {'measure': "Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}, {'measure': "Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}, {'measure': "Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied", 'timeFrame': 'From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography', 'Child', 'Preoperative period'], 'conditions': ['Fasting']}, 'referencesModule': {'references': [{'pmid': '19512861', 'type': 'BACKGROUND', 'citation': 'Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.'}, {'pmid': '21364462', 'type': 'BACKGROUND', 'citation': 'Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.'}, {'pmid': '27334390', 'type': 'BACKGROUND', 'citation': 'Fukunaga C, Sugita M, Yamamoto T. Validity of ultrasonographic measurement of gastric volume in fasted pediatric patients without sedation. J Anesth. 2016 Oct;30(5):900-3. doi: 10.1007/s00540-016-2204-3. Epub 2016 Jun 22.'}, {'pmid': '21307770', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.'}, {'pmid': '21712716', 'type': 'BACKGROUND', 'citation': "Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1."}, {'pmid': '19821343', 'type': 'BACKGROUND', 'citation': "Brady M, Kinn S, Ness V, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005285. doi: 10.1002/14651858.CD005285.pub2."}, {'pmid': '27166876', 'type': 'BACKGROUND', 'citation': 'Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia\n\nExclusion Criteria:\n\n* History of surgery on the esophagus or stomach\n* History of gastrointestinal disease\n* Ambulatory surgery\n* Considered inappropriate by the investigator'}, 'identificationModule': {'nctId': 'NCT03017066', 'briefTitle': 'Ultrasound Assessment of Preoperative Gastric Volume in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients', 'orgStudyIdInfo': {'id': '1612100815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infant formula', 'description': 'Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.', 'interventionNames': ['Device: Ultrasound', 'Other: General anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Carbohydrate drink', 'description': 'Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.', 'interventionNames': ['Device: Ultrasound', 'Other: General anesthesia']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.', 'armGroupLabels': ['Carbohydrate drink', 'Infant formula']}, {'name': 'General anesthesia', 'type': 'OTHER', 'description': 'Scheduled operation under general anesthesia', 'armGroupLabels': ['Carbohydrate drink', 'Infant formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}