Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-01 @ 2:57 PM
Study NCT ID:
NCT05388266
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2022-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Paratracheal Pressure 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expiratory tidal volume', 'timeFrame': 'For 2 min of mask ventilation after the induction of anesthesia', 'description': 'Volume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation'}], 'secondaryOutcomes': [{'measure': 'Peak inspiratory pressure', 'timeFrame': 'For 2 min of mask ventilation after the induction of anesthesia', 'description': 'Peak inspiratory pressure on the screen is recorded during mask ventilation.'}, {'measure': 'Inadequate tidal volume', 'timeFrame': 'For 2 min of mask ventilation after the induction of anesthesia', 'description': 'Incidence of tidal volume less than 150 mL is recorded.'}, {'measure': 'Incidence of hypoxia', 'timeFrame': 'For 2 min of mask ventilation after the induction of anesthesia', 'description': 'Occurrence of hypoxia (SpO2 \\<90%) is recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilation']}, 'referencesModule': {'references': [{'pmid': '37418060', 'type': 'DERIVED', 'citation': 'Seol T, Kim H, Chang JE, Kang Y, Hwang JY. Effect of paratracheal pressure on the effectiveness of mask ventilation in obese anesthetized patients: a randomized, cross-over study. J Clin Monit Comput. 2024 Feb;38(1):31-36. doi: 10.1007/s10877-023-01048-8. Epub 2023 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery\n\nExclusion Criteria:\n\n* Structural abnormalities or diseases in the face, neck, upper airway, or esophagus\n* Increased risk of aspiration (pregnancy)\n* Carotid artery stenosis, cerebrovascular disease'}, 'identificationModule': {'nctId': 'NCT05388266', 'briefTitle': 'Effect of Paratracheal Pressure on Mask Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients', 'orgStudyIdInfo': {'id': '05112022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paratracheal pressure', 'description': 'After the induction of anesthesia, paratracheal pressure is applied during mask ventilation.', 'interventionNames': ['Other: Mask ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No pressure', 'description': 'After the induction of anesthesia, no pressure is applied during mask ventilation.', 'interventionNames': ['Other: Mask ventilation']}], 'interventions': [{'name': 'Mask ventilation', 'type': 'OTHER', 'description': 'Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.', 'armGroupLabels': ['No pressure', 'Paratracheal pressure']}]}, '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}