Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01452867
Status:
COMPLETED
Last Update Posted:
2011-10-17
First Post:
2011-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017214', 'term': 'Laryngeal Masks'}], 'ancestors': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008397', 'term': 'Masks'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-14', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway Management time until first effective Ventilation', 'timeFrame': '90 sec', 'description': 'Effective Ventilation within 90 Seconds required'}], 'secondaryOutcomes': [{'measure': 'Stomach inflation', 'timeFrame': '60 sec', 'description': 'Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Airway', 'Bag-Valve -Mask- Ventilation', 'Laryngeal Mask - Ventilation', 'Laryngeal Tube - Ventilation'], 'conditions': ['Cardiopulmonary Arrest']}, 'descriptionModule': {'briefSummary': 'Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.', 'detailedDescription': 'During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n\n -\\> 18 years old\n* elective surgery in general anesthesia\n\nExclusion Criteria:\n\n* Patient not sober\n* BMI \\> 35kg/m2\n* Pathologies of cerebral spine or peripheral neurological deficit\n* Hiatus hernia, history of gastric reflux\n* Stomach or Esophagus -Operation in the medical history\n* Acute respiratory infection or obstructive lung disease\n* Non elective surgery\n* facial deformity'}, 'identificationModule': {'nctId': 'NCT01452867', 'briefTitle': 'Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme', 'organization': {'class': 'OTHER', 'fullName': 'Krankenhaus Bruneck'}, 'officialTitle': 'Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme', 'orgStudyIdInfo': {'id': 'BLS VENT 2011/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bag-Mask-Ventilation', 'description': 'Bag-Valve Mask-Ventilation in 50 patients in general anesthesia', 'interventionNames': ['Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal Mask Ventilation', 'description': 'Laryngeal Mask Ventilation in 50 patients in general anesthesia', 'interventionNames': ['Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal Tube Ventilation', 'description': 'Laryngeal Tube Ventilation in 50 patients in general anesthesia', 'interventionNames': ['Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))']}], 'interventions': [{'name': 'Bag-Valve-Mask-Ventilation (Ambu Facemask)', 'type': 'DEVICE', 'otherNames': ['Ambu Facemask'], 'description': 'Bag-Valve Mask-Ventilation', 'armGroupLabels': ['Bag-Mask-Ventilation']}, {'name': 'Laryngeal Mask (Laryngeal Mask Airway Supreme)', 'type': 'DEVICE', 'otherNames': ['Laryngeal Mask Airway Supreme'], 'description': 'Ventilation', 'armGroupLabels': ['Laryngeal Mask Ventilation']}, {'name': 'Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))', 'type': 'DEVICE', 'otherNames': ['Laryngeal Tube LT-S-D (VBM)'], 'description': 'Ventilation', 'armGroupLabels': ['Laryngeal Tube Ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39031', 'city': 'Bruneck', 'state': 'Bolzano', 'country': 'Italy', 'facility': 'Krankenhaus Bruneck', 'geoPoint': {'lat': 46.79942, 'lon': 11.93429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krankenhaus Bruneck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University Innsbruck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med univ.', 'investigatorFullName': 'Gruber Elisabeth', 'investigatorAffiliation': 'Krankenhaus Bruneck'}}}}