Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02259569
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2014-09-22', 'studyFirstSubmitQcDate': '2014-10-05', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'dynamic compliance', 'timeFrame': '1 min after end of surgery'}, {'measure': 'typical gurgle or whoosh sound', 'timeFrame': '1 min after caudal block', 'description': 'gastric insufflation determined by continuous epigastric auscultation'}], 'primaryOutcomes': [{'measure': 'Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.', 'timeFrame': '1 min after I-gel insertion'}], 'secondaryOutcomes': [{'measure': 'oropharyngeal leak pressure', 'timeFrame': '1 min after caudal block'}, {'measure': 'FOB grade', 'timeFrame': '1 min after I-gel insertion', 'description': 'grade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible'}, {'measure': 'peak airway pressure', 'timeFrame': '1 min after I-gel insertion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric insufflation', 'I-gel', 'Peak airway pressure', 'Pressure-controlled ventilation', 'Volume-Controlled Ventilation', 'pediatric patient'], 'conditions': ['Pediatric Urologic Surgeries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.\n\nExclusion Criteria:\n\n* parent refusal\n\n * clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration'}, 'identificationModule': {'nctId': 'NCT02259569', 'briefTitle': 'Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0594'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCV group', 'description': 'After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode.', 'interventionNames': ['Other: Pressure-controlled ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VCV group', 'description': 'After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode.', 'interventionNames': ['Other: Volume-controlled ventilation']}], 'interventions': [{'name': 'Pressure-controlled ventilation', 'type': 'OTHER', 'armGroupLabels': ['PCV group']}, {'name': 'Volume-controlled ventilation', 'type': 'OTHER', 'armGroupLabels': ['VCV group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}