Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 11:34 AM
Study NCT ID:
NCT04378192
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2020-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017214', 'term': 'Laryngeal Masks'}, {'id': 'D008397', 'term': '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': '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'}, {'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to intubation TTI', 'timeFrame': 'During the action of intubation after induction of anaesthesia', 'description': 'The time starts with insertion of glidescop and ends at its withdrawal'}], 'secondaryOutcomes': [{'measure': 'View of the glottis', 'timeFrame': 'During the action of intubation after induction of anaesthesia', 'description': "Based on the percentage of glottic opening (POGO) score as well as Cormack and Lehane's (C\\&L) classification"}, {'measure': 'Number of attempts required for intubation,', 'timeFrame': 'During the action of intubation after induction of anaesthesia', 'description': 'How many times the anaesthetist needs to try to succeed in insertion of the endotracheal tube'}, {'measure': "Anaesthetist's satisfaction score", 'timeFrame': 'During the action of intubation after induction of anaesthesia', 'description': 'On a scale rang from 0 representing totally dissatisfied to 10 representing fully satisfied'}, {'measure': 'Intubation difficulty score (IDS)', 'timeFrame': 'During the action of intubation after induction of anaesthesia', 'description': 'Intubation difficulty score (IDS) is the sum of seven variables, each presents 1 point, score 0 represents easy intubation, score 1 to 5 represents moderate difficulty and score more than 5 was considered difficult intubation.'}, {'measure': 'Need for external pressure during intubation', 'timeFrame': 'During the action of intubation after induction of anaesthesia', 'description': 'to direct the larynx downward to facilitate endotracheal intubation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on.', 'detailedDescription': 'The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is bordered by the risk of difficult ventilation and intubation with the subsequent events of hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.\n\nOne problem here is the difficulty of ventilating a morbidly obese patient, in this study the investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obese patient BMI\\>40\n* ASA I, II, III\n* Elective sleeve gastrectomy\n\nExclusion Criteria:\n\n* Oral cavity infection or pathological abnormalities\n* Suspected or known abnormalities in supraglottic anatomy\n* Patients planned for awake fiberoptic intubation'}, 'identificationModule': {'nctId': 'NCT04378192', 'briefTitle': 'Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Assessment of the Use of Laryngeal Mask Airway as Abridge for Intubation of Morbidly Obese Patients Undergoing Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'LMA obesity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Face mask ventilation', 'description': 'Use of face mask ventilation technique after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy', 'interventionNames': ['Device: face mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal mask ventilation', 'description': 'Use of laryngeal mask airway LMA for ventilation after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy', 'interventionNames': ['Device: Laryngeal mask airway']}], 'interventions': [{'name': 'Laryngeal mask airway', 'type': 'DEVICE', 'otherNames': ['LMA'], 'description': 'Insertion of laryngeal mask airway before intubation of a morbidly obese patient', 'armGroupLabels': ['Laryngeal mask ventilation']}, {'name': 'face mask', 'type': 'DEVICE', 'description': 'use of face mask before intubation of a morbidly obese patient', 'armGroupLabels': ['Face mask ventilation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and intensive care', 'investigatorFullName': 'Abdelrhman Alshawadfy', 'investigatorAffiliation': 'Suez Canal University'}}}}