Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
Study NCT ID:
NCT02466295
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2015-06-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gel
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gastric antral area', 'timeFrame': 'Within 5 minutes after the end of surgery', 'description': 'The gastric antral area will be measured using ultrasonography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the pressure controlled ventilation can reduce gastric insufflation compared to the volume controlled ventilation in patients who were mechanically ventilated with the i-gel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia\n\nExclusion Criteria:\n\n* upper gastrointestinal surgery,\n* surgery of long duration more than 4 hours,\n* anticipated difficult intubation,\n* body mass index more than 35 kg/m2,\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02466295', 'briefTitle': 'The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gel', 'nctIdAliases': ['NCT02425618'], 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2015-0280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volume-controlled ventilation', 'description': "The patient's lungs will be mechanically ventilated using the volume-controlled ventilation with tidal volume 8 ml/kg.", 'interventionNames': ['Other: Volume-controlled ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Pressure-controlled ventilation', 'description': "The patient's lungs will be mechanically ventilated using the pressure-controlled ventilation with tidal volume 8 ml/kg.", 'interventionNames': ['Other: Pressure-controlled ventilation']}], 'interventions': [{'name': 'Volume-controlled ventilation', 'type': 'OTHER', 'description': "I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the volume-controlled mode with tidal volume 8 ml/kg during surgery.", 'armGroupLabels': ['Volume-controlled ventilation']}, {'name': 'Pressure-controlled ventilation', 'type': 'OTHER', 'description': "I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the pressure-controlled mode with tidal volume 8 ml/kg during surgery.", 'armGroupLabels': ['Pressure-controlled ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}