Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-28 @ 5:31 AM
Study NCT ID:
NCT03996161
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2019-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Semi-sitting Position on Mask Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056888', 'term': 'Patient Positioning'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expiratory tidal volume', 'timeFrame': '1 minute after the induction of anesthesia', 'description': 'Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.'}], 'secondaryOutcomes': [{'measure': 'Minute ventilation during mask ventilation in the supine and semi-sitting positions', 'timeFrame': '1 minute after anesthesia induction', 'description': 'Minute ventilation is assessed during mask ventilation'}, {'measure': 'The incidence of inadequate mask ventilation or dead space ventilation.', 'timeFrame': 'during mask ventilation', 'description': 'The incidence of inadequate mask ventilation or dead space ventilation is recorded.'}, {'measure': 'Peak inspiratory pressure', 'timeFrame': 'during mask ventilation', 'description': 'Peak inspiratory pressure is recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilation']}, 'referencesModule': {'references': [{'pmid': '33600105', 'type': 'DERIVED', 'citation': 'Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Aug 1;38(8):825-830. doi: 10.1097/EJA.0000000000001473.'}]}, 'descriptionModule': {'briefSummary': 'We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese patients undergoing general anesthesia\n\nExclusion Criteria:\n\n* diseases or structural abnormalities in the upper airway\n* those who were at risk of aspiration\n* cardiovascular or respiratory diseases\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03996161', 'briefTitle': 'Effect of Semi-sitting Position on Mask Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients', 'orgStudyIdInfo': {'id': '2019-1231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supine position', 'description': 'After the induction of anesthesia, mask ventilation is performed in the supine position.', 'interventionNames': ['Other: patient position']}, {'type': 'EXPERIMENTAL', 'label': 'Semi-sitting position', 'description': 'After the induction of anesthesia, mask ventilation is performed in the semi-sitting position.', 'interventionNames': ['Other: patient position']}], 'interventions': [{'name': 'patient position', 'type': 'OTHER', 'description': 'After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.', 'armGroupLabels': ['Semi-sitting position', 'Supine position']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}