Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT03558620
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of an Endoscopic Bite Block on Mask Ventilation
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': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expiratory tidal volume', 'timeFrame': 'during mask ventilation after anesthesia induction', 'description': 'Expiratory tidal volume with one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation'}], 'secondaryOutcomes': [{'measure': 'Minute ventilation', 'timeFrame': 'during mask ventilation after anesthesia induction', 'description': 'Minute ventilationwith one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation'}, {'measure': 'Incidence of inadequate ventilation or dead space ventilation', 'timeFrame': 'during mask ventilation after anesthesia induction', 'description': 'Inadequate mask ventilation and dead-space ventilation are defined as a mean expiratory tidal volume of less than 4 mL kg-1 of predicted body weight and a mean expiratory tidal volume of less than 150 mL per breath with no clinical signs, respectively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['manual ventilation'], 'conditions': ['Ventilator Lung']}, 'referencesModule': {'references': [{'pmid': '23473817', 'type': 'BACKGROUND', 'citation': 'Hart D, Reardon R, Ward C, Miner J. Face mask ventilation: a comparison of three techniques. J Emerg Med. 2013 May;44(5):1028-33. doi: 10.1016/j.jemermed.2012.11.005. Epub 2013 Mar 7.'}, {'pmid': '20808210', 'type': 'BACKGROUND', 'citation': 'Joffe AM, Hetzel S, Liew EC. A two-handed jaw-thrust technique is superior to the one-handed "EC-clamp" technique for mask ventilation in the apneic unconscious person. Anesthesiology. 2010 Oct;113(4):873-9. doi: 10.1097/ALN.0b013e3181ec6414.'}, {'pmid': '18853942', 'type': 'BACKGROUND', 'citation': 'Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under same pressure controlled mode in ventilator with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)', 'detailedDescription': 'Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under the same pressure controlled mode in ventilator (Pressure 15cmH2O, Respiratory rate 15/min, I:E=1:1) with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for elective surgery under general anesthesia and agree with the purpose of the study\n\nExclusion Criteria:\n\n* patients with diseases or structural abnormalities in the upper airway, wobbly teeth, and limited mouth opening of less than 3.5 cm or those who were at risk of aspiration'}, 'identificationModule': {'nctId': 'NCT03558620', 'briefTitle': 'Effect of an Endoscopic Bite Block on Mask Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Effect of an Endoscopic Bite Block on Mask Ventilation in Anesthetized and Paralyzed Patients', 'orgStudyIdInfo': {'id': '2018/00/0000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1O2', 'description': 'A fitting mask is held by one hand -\\> one hand with an endoscopic bite block -\\> held by two hands', 'interventionNames': ['Procedure: mask ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 12O', 'description': 'A fitting mask is held by one hand -\\> held by two hands-\\> one hand with an endoscopic bite block', 'interventionNames': ['Procedure: mask ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Group O12', 'description': 'A fitting mask is held by one hand with an endoscopic bite block-\\>by one hand -\\> by two hands', 'interventionNames': ['Procedure: mask ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Group O21', 'description': 'A fitting mask is held by one hand with an endoscopic bite block -\\> by two hands-\\> one hand', 'interventionNames': ['Procedure: mask ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 21O', 'description': 'A fitting mask is held by two hands -\\> one hand -\\> one hand with an endoscopic bite block', 'interventionNames': ['Procedure: mask ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2O1', 'description': 'A fitting mask is held by two hands -\\>one hand with an endoscopic bite block-\\> by one hand', 'interventionNames': ['Procedure: mask ventilation']}], 'interventions': [{'name': 'mask ventilation', 'type': 'PROCEDURE', 'description': 'mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)', 'armGroupLabels': ['Group 12O', 'Group 1O2', 'Group 21O', 'Group 2O1', 'Group O12', 'Group O21']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Young Hwang, M.D., phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Metropolitan Government Seoup National University Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Department of Anesthesiology and Pain medicine', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}