Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 5:28 PM
Study NCT ID:
NCT01385969
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2011-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LMA Cuff Pressure and LMA-induced Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-06-29', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure of the syringe after inflation of the LMA cuff', 'timeFrame': 'after inflation, 1 hour into surgery'}], 'secondaryOutcomes': [{'measure': 'Number of patients with dysphagia and/or dysphonia', 'timeFrame': '1, 2, and 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overinflation of LMAs'], 'conditions': ['Sore Throat', 'Dysphagia', 'Dysphonia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and allowing them to recoil will put the pressure of the LMA cuff within the safety range. It will also determine if remaining within this safety range has an effect on complications after surgery..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo a surgical procedure less than 2 hours in duration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered Mayo Clinic in Florida patients scheduled to undergo a surgery\n* Planned use of LMA during surgery\n* between the ages of 18-99\n* short duration (\\<2 hours elective surgery)\n\nExclusion Criteria:\n\n* recent history of upper respiratory tract infection\n* intra-cavitary or laparoscopic procedure\n* risk of pulmonary aspiration\n* known difficult airway\n* history of gastric reflux\n* BMI \\> 40\n* lateral or prone positions\n* oral or nasal surgery'}, 'identificationModule': {'nctId': 'NCT01385969', 'briefTitle': 'LMA Cuff Pressure and LMA-induced Complications', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications', 'orgStudyIdInfo': {'id': '11-001506'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard Practice', 'interventionNames': ['Device: Standard inflation of LMA cuff']}, {'label': 'Syringe recoil', 'interventionNames': ['Device: Pressure check with syringe recoil']}, {'label': 'Pressure Transducer', 'interventionNames': ['Device: Pressure check by pressure transducer']}], 'interventions': [{'name': 'Standard inflation of LMA cuff', 'type': 'DEVICE', 'otherNames': ['LMA inflation routine clinical practice'], 'description': 'LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by manual palpation of the cuff per standard practice.', 'armGroupLabels': ['Standard Practice']}, {'name': 'Pressure check with syringe recoil', 'type': 'DEVICE', 'otherNames': ['LMA cuff pressure by syringe recoil'], 'description': 'LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil', 'armGroupLabels': ['Syringe recoil']}, {'name': 'Pressure check by pressure transducer', 'type': 'DEVICE', 'otherNames': ['LMA cuff pressure checked by pressure transducer'], 'description': 'LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.', 'armGroupLabels': ['Pressure Transducer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Christopher Robards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christopher B. Robards', 'investigatorAffiliation': 'Mayo Clinic'}}}}