Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 12:53 PM
Study NCT ID:
NCT00836095
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2009-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'svaida@hmc.psu.edu', 'phone': '7175318433', 'title': 'Sonia Vaida MD, Professor of Anesthesiology', 'organization': 'Penn State Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Supreme LMA', 'description': 'Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.\n\nSupreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Proseal LMA', 'description': 'Proseal is a multiple use, variant of the laryngeal mask airway.\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.\n\nProseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insertion Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supreme LMA', 'description': 'Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.'}, {'id': 'OG001', 'title': 'Proseal LMA', 'description': 'Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '10', 'groupId': 'OG000'}, {'value': '18', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During intubation of the patient', 'description': "The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.", 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insertion Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supreme LMA', 'description': 'Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.'}, {'id': 'OG001', 'title': 'Proseal LMA', 'description': 'Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During intubation of the patient', 'description': 'Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.', 'unitOfMeasure': 'Number of successful airway insertions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supreme LMA', 'description': 'Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.'}, {'id': 'FG001', 'title': 'Proseal LMA', 'description': 'Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway.\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Supreme LMA', 'description': 'The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.\n\nSupreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.'}, {'id': 'BG001', 'title': 'Proseal LMA', 'description': 'The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.\n\nProseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '14', 'groupId': 'BG000'}, {'value': '41', 'spread': '14', 'groupId': 'BG001'}, {'value': '45', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-17', 'studyFirstSubmitDate': '2009-02-02', 'resultsFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-05', 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion Time', 'timeFrame': 'During intubation of the patient', 'description': "The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation."}], 'secondaryOutcomes': [{'measure': 'Insertion Success Rate', 'timeFrame': 'During intubation of the patient', 'description': 'Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['laryngeal mask, proseal'], 'conditions': ['Adverse Effect of Unspecified General Anesthetics']}, 'descriptionModule': {'briefSummary': 'Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.\n\nThe research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 75 years\n* ASA I and II\n* Mallampatti class: I and II\n* Thyromental distance \\> than 6.5 cm\n* Interincisor distance \\> than 3 cm\n* BMI \\< 35 Kg/m2\n* Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position\n\nExclusion Criteria:\n\n* Weight \\< 50 kg\n* BMI \\> 35 Kg/m2\n* Pregnant patients\n* Known or expected difficult airway\n* Patients with active, untreated and unresolved gastroesophageal reflux\n* Esophageal pathology, pulmonary pathology\n* Laparoscopic procedures\n* ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure'}, 'identificationModule': {'nctId': 'NCT00836095', 'briefTitle': 'Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'IRB 29920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Supreme LMA', 'description': 'Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.', 'interventionNames': ['Device: Supreme Laryngeal mask airway']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proseal LMA', 'description': 'Proseal is a multiple use, variant of the laryngeal mask airway.\n\nThe choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.', 'interventionNames': ['Device: Proseal laryngeal mask airway']}], 'interventions': [{'name': 'Supreme Laryngeal mask airway', 'type': 'DEVICE', 'description': 'Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant', 'armGroupLabels': ['Supreme LMA']}, {'name': 'Proseal laryngeal mask airway', 'type': 'DEVICE', 'description': 'Proseal is a multiple use, variant of the laryngeal mask airway', 'armGroupLabels': ['Proseal LMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'PennState Hershey Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Sonia J Vaida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, Vice Chair for Research', 'investigatorFullName': 'Sonia Vaida', 'investigatorAffiliation': 'Penn State University'}}}}