Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04376918
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bag-Valve-Guedel Adaptor Vs Common Face Mask for the Ventilation of Anesthetized Bearded Men
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': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, randomized (sequence randomization), controlled (cross over)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tidal Volume', 'timeFrame': '2 minutes', 'description': 'Tidal volume will be monitored while the volunteer breathes through the BVGA or the face mask. The second minute of each of the interventions will be used for the data analysis.'}], 'secondaryOutcomes': [{'measure': 'End tidal CO2 levels (EtCO2)', 'timeFrame': '2 minutes', 'description': 'EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask. The second minute of each of the interventions will be used for the data analysis.'}, {'measure': 'Ease of use', 'timeFrame': '30 minutes', 'description': 'The number of hands (1 or 2) the physician had to use during the ventilation procedure while using each device (mask or BVGA)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ventilation', 'airway management', 'intubation', 'emergency responders'], 'conditions': ['Ventilation']}, 'referencesModule': {'references': [{'pmid': '33444455', 'type': 'BACKGROUND', 'citation': 'Gavish L, Rittblat M, Gertz SD, Shaylor R, Weissman C, Eisenkraft A. Ventilating the Bearded: A Randomized Crossover Trial Comparing a Novel Bag-Valve-Guedel Adaptor to a Standard Mask. Mil Med. 2020 Aug 14;185(7-8):e1300-e1308. doi: 10.1093/milmed/usz378.'}]}, 'descriptionModule': {'briefSummary': 'Ventilation of a bearded patient with the commonly used face mask has low efficiency because of difficulties to achieve a tight seal around the mouth and nose. The purpose of this study is to evaluate the efficacy of a novel bag valve Guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a Guedel - eliminating the need for a face mask in anesthetized bearded men.', 'detailedDescription': 'Ventilating a patient using a bag valve and a face mask is not easy to perform, especially for a long period of time, and mandates experience and strength by the care giver. The need for a tight seal around the mouth and nose is a major challenge especially if the patient has a beard. Nevertheless, the face mask is the only approved respiratory support that medics and other basic care givers are allowed to use in the out-of-the-hospital setting, and only physicians and paramedics are allowed to use more advanced techniques, providing a definite airway. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field. We have shown previously that the BVGA provides significantly more efficient (less leak) ventilation compared to a facemask, in a randomized, cross-over (BVGA vs mask) controlled clinical trial (NCT02768246) with healthy bearded volunteers that were awake and breathed spontaneously.\n\nThe purpose of this study is to evaluate the safety and efficacy of the BVGA compared to a classic facemask in anesthetized bearded volunteers.\n\nStudy Design:\n\nProspective, randomized (sequence randomization), controlled (cross over). The study population will include ASA 1 or 2patients that are planned to undergo elective surgery under general anesthesia with non-depolarizing muscle relaxants. These will include 45 men with beards, and 14 men without beards or women\n\nAll subjects will sign an informed consent before participation and will be randomized by sequence (BVGA followed by Mask or Mask followed by BVGA). The physician will initiate anesthesia induction with a face mask according to normal procedures. Experimental phase: According to the sequence of devices determined in the randomization, the physician will then place the first device for 2 minutes, and then replace it with the second device for 2 minutes. The devices will be connected to the operating ventilation machines and physiological and respiratory parameters will be monitored continuously. During the experimental phase, a study assistant will note if the physician used 1 or 2 hands during the ventilation with the experimental devices (BVGA/mask).\n\nThe physician will then continue the anesthesia procedures as planned. The physician will complete a questionnaire related to the use of the BVGA in comparison to the standard mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Most volunteers are required to have a beard, therefore most volunteers will be men.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Beards men with different levels of beard fullness, men without beards, or women\n2. planned to undergo elective surgery with endotracheal intubation using non-depolarizing neuromuscular blocking agents\n3. ASA 1 or 2\n4. BMI ≤30\n\nExclusion Criteria:\n\n1. Pregnant women\n2. ASA\\>2\n3. Presence of facial fractures or injuries.\n4. Expected to suffer from aspiration and requiring rapid sequence induction\n5. Edentulous or unstable teeth\n6. Morbid obesity\n7. Suspected difficult intubation\n8. Suspected difficult ventilation (except of the presence of beard)\n9. If an unexpected difficulty in ventilation will arise during induction, patient will be excluded from study.\n10. Worker from Hadassah Medical Center'}, 'identificationModule': {'nctId': 'NCT04376918', 'acronym': 'BVGA02', 'briefTitle': 'Bag-Valve-Guedel Adaptor Vs Common Face Mask for the Ventilation of Anesthetized Bearded Men', 'organization': {'class': 'OTHER', 'fullName': 'Hebrew University of Jerusalem'}, 'officialTitle': 'Evaluating the Safety and Efficacy of the Bag-Valve-Guedel Adaptor in Anesthetized Bearded Men in Comparison to the Standard Face Mask - a Prospective, Randomized Cross-over Clinical Trial', 'orgStudyIdInfo': {'id': '0172-20-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Begin with BVGA', 'description': 'After initial anesthesia induction, anesthetized volunteers will be ventilated through through the BVGA for 2 minutes and then through the face-mask for 2 minutes. The normal anesthesia procedures will then be resumed.\n\nThe BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation The Mask is a classic face mask', 'interventionNames': ['Device: Begin with BVGA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Begin with Face-mask', 'description': 'After initial anesthesia induction, anesthetized volunteers will be ventilated through the face mask for 2 minutes and then through the BVGA for 2 minutes. The normal anesthesia procedures will then be resumed\n\nThe BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation The Mask is a classic face mask', 'interventionNames': ['Device: Begin with Face-mask']}], 'interventions': [{'name': 'Begin with BVGA', 'type': 'DEVICE', 'description': 'Device: BVGA The BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation\n\nOther Names:\n\n• Bag Valve Guedel Adaptor Device: Face Mask Classic face mask', 'armGroupLabels': ['Begin with BVGA']}, {'name': 'Begin with Face-mask', 'type': 'DEVICE', 'description': 'Device: BVGA The BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation\n\nOther Names:\n\n• Bag Valve Guedel Adaptor Device: Face Mask Classic face mask', 'armGroupLabels': ['Begin with Face-mask']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Haddasah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Shimon Firman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}, {'name': 'Lilach Gavish, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hebrew University of Jerusalem'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hadassah Medical Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Lilach Gavish', 'investigatorAffiliation': 'Hebrew University of Jerusalem'}}}}