Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-02-11 @ 3:25 AM
Study NCT ID:
NCT02923427
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ozbilginsule@gmail.com', 'phone': '905055252901', 'title': 'Anaesthesiology and Intensive Care, Sule Ozbilgin', 'organization': 'DorkuzEU'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hour', 'eventGroups': [{'id': 'EG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Airway Seal Pressure Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '31.20', 'spread': '8.07', 'groupId': 'OG000'}, {'value': '27.58', 'spread': '7.16', 'groupId': 'OG001'}]}]}, {'title': 'at 15 min', 'categories': [{'measurements': [{'value': '30.10', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '28.76', 'spread': '7.33', 'groupId': 'OG001'}]}]}, {'title': 'at 30 min', 'categories': [{'measurements': [{'value': '29.92', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '28.71', 'spread': '6.65', 'groupId': 'OG001'}]}]}, {'title': 'at 60 min', 'categories': [{'measurements': [{'value': '30.31', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '29.13', 'spread': '6.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at 15, 30 and 60 minutes', 'description': 'This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'categories': [{'measurements': [{'value': '3.941', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.945', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during pneumoperitoneum', 'description': 'quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastric Tube Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'very easy', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'easy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'very difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'following airway device insertion up to 5 minutes', 'description': 'Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pharyngolaryngeal Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'at first hour', 'categories': [{'measurements': [{'value': '0.43', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': '24th hour', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'postoperative first hour and 24th hour', 'description': 'Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sufficiency of Pneumoperitoneum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'sufficient', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'insufficient', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': 'Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Airway Pressure Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '5.84', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '5.82', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'at 15 min', 'categories': [{'measurements': [{'value': '7.84', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '7.87', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'at 30 min', 'categories': [{'measurements': [{'value': '7.45', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'at 60 min', 'categories': [{'measurements': [{'value': '6.51', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '6.29', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at 15, 30 and 60 minutes', 'description': 'Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dysphonia With Yes/no.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'at first hour-no', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'at 24th hour-no', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'postoperative first hour and 24th hour', 'description': 'We evaluated while a patient was talking with us that the patient has dysphonia or not .', 'unitOfMeasure': 'Number of Participants without Dysphonia', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'OG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'classes': [{'title': 'at first hour-no', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'at 24th hour-no', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'postoperative first hour and 24th hour', 'description': 'We asked the question that you have a pain while you were swallowing, yes or not.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'FG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The reasons:\n\nn= 2 Convert to Laparotomy n=1 Desaturation n=1 LMA-S can not be placed', 'groupId': 'FG000', 'numSubjects': '51'}, {'comment': 'The reasons:\n\nn = 2 Convert to Laparotomy', 'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'convert to laparatomy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'destaturation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'can not replace LMA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Laryngeal Mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance\n\nLaryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications'}, {'id': 'BG001', 'title': 'I-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance\n\ni-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.55', 'spread': '9.34', 'groupId': 'BG000'}, {'value': '36.44', 'spread': '8.31', 'groupId': 'BG001'}, {'value': '35.49', 'spread': '8.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-21', 'size': 247195, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-12T05:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2016-09-22', 'resultsFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-12', 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway Seal Pressure Values', 'timeFrame': 'At baseline and at 15, 30 and 60 minutes', 'description': 'This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.'}], 'secondaryOutcomes': [{'measure': 'Visual Quality', 'timeFrame': 'during pneumoperitoneum', 'description': 'quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).'}, {'measure': 'Gastric Tube Insertion', 'timeFrame': 'following airway device insertion up to 5 minutes', 'description': 'Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.'}, {'measure': 'Postoperative Pharyngolaryngeal Morbidity', 'timeFrame': 'postoperative first hour and 24th hour', 'description': 'Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain).'}, {'measure': 'Sufficiency of Pneumoperitoneum', 'timeFrame': 'baseline', 'description': 'Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.'}, {'measure': 'Mean Airway Pressure Values', 'timeFrame': 'At baseline and at 15, 30 and 60 minutes', 'description': 'Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.'}, {'measure': 'Dysphonia With Yes/no.', 'timeFrame': 'postoperative first hour and 24th hour', 'description': 'We evaluated while a patient was talking with us that the patient has dysphonia or not .'}, {'measure': 'Disphagia', 'timeFrame': 'postoperative first hour and 24th hour', 'description': 'We asked the question that you have a pain while you were swallowing, yes or not.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laryngeal mask Supreme', 'i-gel', 'laparoscopic gynecological surgery'], 'conditions': ['Airway Morbidity', 'Anaesthesia']}, 'descriptionModule': {'briefSummary': 'To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on ventilation parameters and surgical view during Trendelenburg Position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.', 'detailedDescription': "Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.\n\nThe patients are randomly assigned to 2 groups:\n\n* Group 1: i-gel\n* Group 2: LMA- Supreme\n\nProcedure:\n\nThe investigation protocol contains the following sections:\n\n1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.\n2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg).\n3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size of airway device, time an number of attempts.\n4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion\n5. Functionality of the gastric drainage channel of the airway device: passage of a 14 G size tube.\n6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.\n7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.\n8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 \\< 92%)\n9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists classification group I-II\n2. between 18-65 years\n3. undergoing elective laparoscopic gynecological surgery\n\nExclusion Criteria:\n\n1. Those with any neck or upper respiratory tract pathology\n2. Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)\n3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)\n4. Obese patients (BMI \\>35)\n5. Those with throat pain, dysphagia and dysphonia\n6. Those with possible or previous difficult airway\n7. Those with operations planned for longer than 4 hours\n8. Conversion to laparatomy\n9. Neuromuscular blocking agent used'}, 'identificationModule': {'nctId': 'NCT02923427', 'briefTitle': 'I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery', 'orgStudyIdInfo': {'id': '266-SBKAEK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal mask Supreme', 'description': 'Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance', 'interventionNames': ['Device: Laryngeal mask Supreme Evaluation']}, {'type': 'EXPERIMENTAL', 'label': 'i-gel', 'description': 'Insertion of the "i-gel" and evaluation of its clinical performance', 'interventionNames': ['Device: i-gel Evaluation']}], 'interventions': [{'name': 'Laryngeal mask Supreme Evaluation', 'type': 'DEVICE', 'description': 'Evaluation of clinical performance in terms of Insertion, ventilation and complications', 'armGroupLabels': ['Laryngeal mask Supreme']}, {'name': 'i-gel Evaluation', 'type': 'DEVICE', 'description': 'Evaluation of clinical performance in terms of Insertion,ventilation and complications', 'armGroupLabels': ['i-gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Ferim Günenç, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dokuz Eylul University, MD, Anesthesiologists.', 'investigatorFullName': 'Sule Ozbilgin', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}