Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT03619057
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2018-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voice Tessitura and Size of the Required Laryngeal Mask
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between the weight and the tessitura threshold', 'timeFrame': '1 day', 'description': 'Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves.'}], 'secondaryOutcomes': [{'measure': 'Determining the tessitura threshold corresponding to each mask size', 'timeFrame': '1 day', 'description': 'tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngeal Masks']}, 'descriptionModule': {'briefSummary': 'The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.\n\nThe i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).\n\nI-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.\n\nPatients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.\n\nThe investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.\n\nThis hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients up to 10 years old with planned surgery and anticipated use of laryngeal mask i-gel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 10 years\n* Planned surgical procedure with the use of a laryngeal mask\n\nExclusion Criteria:\n\n• Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03619057', 'acronym': 'EVG', 'briefTitle': 'Voice Tessitura and Size of the Required Laryngeal Mask', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Voice Tessitura and Size of the Required Laryngeal Mask', 'orgStudyIdInfo': {'id': 'EVG'}}, 'armsInterventionsModule': {'armGroups': [{'label': '> 18 years', 'interventionNames': ['Other: General anesthesia with laryngeal mask i-gel']}, {'label': '10 to 18 years', 'interventionNames': ['Other: General anesthesia with laryngeal mask i-gel']}], 'interventions': [{'name': 'General anesthesia with laryngeal mask i-gel', 'type': 'OTHER', 'description': 'General anesthesia with laryngeal mask i-gel', 'armGroupLabels': ['10 to 18 years', '> 18 years']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Villeneuve-Saint-Georges', 'country': 'France', 'facility': 'CHI Villeneuve-Saint-Georges', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}