Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-01-24 @ 11:17 PM
Study NCT ID:
NCT03002857
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2016-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-06', 'studyFirstSubmitDate': '2016-12-17', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion times', 'timeFrame': 'Perioperative', 'description': 'It was evaluated that how many secs does it take to insert properly.'}, {'measure': 'Ventilation times', 'timeFrame': 'Perioperative', 'description': 'It was evaluated that how many secs does it take to ventilate the patient.'}, {'measure': 'First attemp success rates', 'timeFrame': 'Perioperative', 'description': 'In how many patients it was inserted at first attempt'}, {'measure': 'The additional maneuvering', 'timeFrame': 'Perioperative', 'description': 'ıt was evaluated how many maneuvers needed to insert the device.'}, {'measure': 'Airway related complications', 'timeFrame': 'Perioperative', 'description': 'Complications like Bloodstain of the mask, Dysphagia, Tongue injury, Lips injury, Teeth injury, Palate injury, Sore throat, Hoarseness, Desaturation , Laryngospasm, Regurgitation/aspiration were evaluated.'}], 'secondaryOutcomes': [{'measure': 'Airway PAP and Plateau pressures', 'timeFrame': 'Perioperative', 'description': 'Both pressures were evaluated following device insertion and then in every 10 mins.'}, {'measure': 'Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg', 'timeFrame': 'Perioperative', 'description': 'Preoperative and following device insertion all haemodynamic parameters were evaluated in every 10 mins.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laryngeal Mask Airway', 'Urologic Surgical Procedure'], 'conditions': ['Airway Management']}, 'descriptionModule': {'briefSummary': 'The most used airway management strategies are different types of supraglottic airway devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of this study was to evaluate and compare the performance of a new type of SAD the Baska Mask® with I-gel and LMA-C regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures in urological surgery as well.', 'detailedDescription': 'The most used airway management strategies are different types of supraglottic airway devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of this study was to evaluate and compare the performance of a new type of SAD the Baska Mask® with I-gel and LMA-C regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures in urological surgery as well.\n\nThe main suggestion about the Baska Mask® is that it\'s the most appropriate airway device with high Paws. In high Paws, higher air leaks may occur from the sides of cuff and this causes hypoventilation. So the main aim of this study is to evaltuate three devices in terms of insertion and ventilation times, the "first attempt" success rates, the additional maneuvering requirements and complications developed after intervention.\n\nThe secondary objective of the study was to evaluate all three SADs in terms of airway pressures producing sufficient tidal volume and hemodynamical parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (ASA) 1-2-3 physical status scheduled for elective surgical procedure for transurethral resection of bladder and ureteroscopy.\n\nExclusion Criteria:\n\n* Under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) \\> 30 kg m-2, ASA physical status 4 or over and patients who met the difficult intubation criteria.'}, 'identificationModule': {'nctId': 'NCT03002857', 'acronym': 'BCIM', 'briefTitle': 'Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University Research Hospital'}, 'officialTitle': 'Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask®in Urological Surgery Regarding Their Efficacy and Safety', 'orgStudyIdInfo': {'id': 'LMA-Urological surgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Classical LMA', 'description': "Classical LMA insertion: LMA-C insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.", 'interventionNames': ['Device: LMA-C']}, {'type': 'EXPERIMENTAL', 'label': 'I-gel', 'description': "I-gel LMA insertion: The I-gel LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.", 'interventionNames': ['Device: I-gel']}, {'type': 'EXPERIMENTAL', 'label': 'The Baska Mask®', 'description': "The Baska Mask® insertion: The Baska Mask® insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.", 'interventionNames': ['Device: Baska Mask']}], 'interventions': [{'name': 'LMA-C', 'type': 'DEVICE', 'description': 'LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.', 'armGroupLabels': ['Classical LMA']}, {'name': 'Baska Mask', 'type': 'DEVICE', 'description': 'Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.', 'armGroupLabels': ['The Baska Mask®']}, {'name': 'I-gel', 'type': 'DEVICE', 'description': 'I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.', 'armGroupLabels': ['I-gel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Asli Demir', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yuksek Ihtisas Research and Educational Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turkiye Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Dr. Ülkü Sabuncu', 'investigatorAffiliation': 'Adiyaman University Research Hospital'}}}}