Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 9:50 PM
Study NCT ID:
NCT04371094
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2020-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sore Throat After Intubation Using Glidescope With Stylet and Bougie
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'double-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative sore throat (POST)', 'timeFrame': 'IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER', 'description': 'report severity of postoperative sore throat and CHANGES that could occur later on'}], 'secondaryOutcomes': [{'measure': 'postoperative sore throat (POST)', 'timeFrame': 'immediately postoperative at recovery room', 'description': 'INCIDENCE of postoperative sore throat'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Sore Throat']}, 'descriptionModule': {'briefSummary': 'This is a prospective double-blinded clinical trial aiming to compare the incidence and severity of sore throat after laparoscopic cholecystectomy when using two different techniques of intubation using glidescope', 'detailedDescription': 'The first technique is loading the endotracheal tube on a stylet the second technique is sliding the endotracheal tube over a bogie that is dragged into the trachea at both techniques, the investigators are using glidescope'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA\n\nExclusion Criteria:\n\n* ANTICIPATED DIFFICULT INTUBATION'}, 'identificationModule': {'nctId': 'NCT04371094', 'briefTitle': 'Sore Throat After Intubation Using Glidescope With Stylet and Bougie', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Comparison Between Using Glidescope With Stylet Technique and With Bougie Technique on the Incidence and Severity of Postoperative Sore Throat Development', 'orgStudyIdInfo': {'id': 'Glidescope and sore throat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stylet', 'description': 'The stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea', 'interventionNames': ['Device: a device to facilitate endotracheal intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bougie', 'description': 'The bougie is a device that is inserted into the trachea and an endotracheal tube is loaded over it and is slide into the trachea', 'interventionNames': ['Device: a device to facilitate endotracheal intubation']}], 'interventions': [{'name': 'a device to facilitate endotracheal intubation', 'type': 'DEVICE', 'description': 'a device to facilitate endotracheal intubation', 'armGroupLabels': ['bougie', 'stylet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'STILL WORKING ON'}, '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'}}}}