Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 2:49 AM
Study NCT ID:
NCT05190757
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supraglottic Airway Needed To Achieve Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014691', 'term': 'Ventilation'}], 'ancestors': [{'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful ventilation', 'timeFrame': 'Up to 15 minutes during the initial period of intubation.', 'description': 'Compare time needed to achieve ventilation'}], 'secondaryOutcomes': [{'measure': 'Subjective criteria of difficult ventilation and intubation', 'timeFrame': 'Up to 30 minutes during the initial period of intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Complication of Anesthesia', 'Difficult or Failed Intubation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare if insertion of laryngeal mask airway (LMA) vs. use of face mask, will reduce the time needed to achieve adequate ventilation prior to insertion of the breathing tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo elective surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 35.\n* Patients willing to participate and provide an informed consent.\n* Patients scheduled to undergo an elective surgical procedure including laparoscopic or robotic that requires GETA.\n\nExclusion Criteria:\n\n* Patients who require administration of succinylcholine for induction/intubation\n* Patients with history of uncontrolled GERD.'}, 'identificationModule': {'nctId': 'NCT05190757', 'briefTitle': 'Supraglottic Airway Needed To Achieve Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Supraglottic Airway Needed To Achieve Ventilation (SANTA)', 'orgStudyIdInfo': {'id': '21-008655'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laryngeal Mask Airway', 'interventionNames': ['Other: Airway and Ventilation']}, {'label': 'Face Mask', 'interventionNames': ['Other: Airway and Ventilation']}], 'interventions': [{'name': 'Airway and Ventilation', 'type': 'OTHER', 'description': 'Insertion of Laryngeal Mask airway for ventilation or use of Face Mask', 'armGroupLabels': ['Face Mask', 'Laryngeal Mask Airway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32223', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Klaus Torp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Klaus D. Torp', 'investigatorAffiliation': 'Mayo Clinic'}}}}