Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-29 @ 9:13 AM
Study NCT ID:
NCT02127632
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2014-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ozbilginsule@gmail.com', 'phone': '90.505.525.29.01', 'title': 'Anaesthesiology and Reanimation', 'organization': 'DorkuzEU'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We studied a female population with normal airways undergoing elective gynaecological laparoscopic surgery.\n\nSecond, we only studied non-obese patients. Third we excluded cases with difficult airway.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group ETT (Endo Tracheal Tube)', 'description': "Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482\n\nLaryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \\& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group LM-S(Laryngeal Mask Supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.\n\nEndotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Airway Pressures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group ETT (Endo Tracheal Tube)', 'description': "Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482\n\nLaryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \\& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"}, {'id': 'OG001', 'title': 'Group LM-S(Laryngeal Mask Supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.\n\nEndotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482'}], 'classes': [{'title': 'T1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '9'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '19'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '17'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At first and last 10 minutes of pneumoperitoneum', 'description': 'The measure is the mean airway pressure (cmH2O):\n\nT1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device', 'unitOfMeasure': 'cmH20', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of Gastric Distention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group ETT (Endo Tracheal Tube)', 'description': "Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482\n\nLaryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \\& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"}, {'id': 'OG001', 'title': 'Group LM-S(Laryngeal Mask Supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.\n\nEndotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482'}], 'classes': [{'categories': [{'measurements': [{'value': '3.24', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Throat Pain According to Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group ETT (Endo Tracheal Tube)', 'description': "Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482\n\nLaryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \\& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"}, {'id': 'OG001', 'title': 'Group LM-S(Laryngeal Mask Supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.\n\nEndotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482'}], 'classes': [{'title': 'postoperative 1st hour', 'categories': [{'measurements': [{'value': '2.04', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'postoperative 24th hours', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'postoperative 1st and 24th hours', 'description': 'Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, 1 hr and 24 hr after the end of surgery according to Visual Analogue Scale. (range min. 0, max.10; \\>4 analgesia planned)', 'unitOfMeasure': 'point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group ETT (Endo Tracheal Tube)', 'description': "Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482\n\nLaryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"}, {'id': 'FG001', 'title': 'Group LM-S(Laryngeal Mask Supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.\n\nEndotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group ETT (Endo Tracheal Tube)', 'description': "Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482\n\nLaryngeal Mask Airway-Supreme: Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \\& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"}, {'id': 'BG001', 'title': 'Group LM-S(Laryngeal Mask Supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.\n\nEndotracheal Tube: ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.36', 'spread': '11.52', 'groupId': 'BG000'}, {'value': '38.86', 'spread': '11.48', 'groupId': 'BG001'}, {'value': '39.11', 'spread': '11.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2014-04-26', 'resultsFirstSubmitDate': '2015-04-26', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-20', 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Airway Pressures', 'timeFrame': 'At first and last 10 minutes of pneumoperitoneum', 'description': 'The measure is the mean airway pressure (cmH2O):\n\nT1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Gastric Distention', 'timeFrame': 'Baseline', 'description': 'To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)'}, {'measure': 'Throat Pain According to Visual Analogue Scale', 'timeFrame': 'postoperative 1st and 24th hours', 'description': 'Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, 1 hr and 24 hr after the end of surgery according to Visual Analogue Scale. (range min. 0, max.10; \\>4 analgesia planned)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laryngeal mask Supreme', 'laparoscopic gynecologic surgery', 'Laryngeal mask during surgery'], 'conditions': ['Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '30968326', 'type': 'DERIVED', 'citation': 'Kuvaki B, Ozbilgin S, Gunenc SF, Kucuk BA. Comparison of LM-Supreme and endotracheal tube in patients undergoing gynecological laparoscopic surgery. J Clin Monit Comput. 2020 Apr;34(2):295-301. doi: 10.1007/s10877-019-00310-2. Epub 2019 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single use device and the presence of a drain tube allows to separate the gastrointestinal and respiratory tracts. We planned to compare ventilation parameters and gastric distension scores of with LM-S vs ETT during laparoscopic gynecological surgery.', 'detailedDescription': 'This prospective, randomized and double-blind study received permission from "Dokuz Eylül University Medical Faculty Non-Interventional Research Ethics Committee" and after obtaining patients\' informed consent, 100 patients with American society of anesthesiologists (ASA) classification group I-II, between 18-65 years, undergoing elective laparoscopic gynecological surgery were included.\n\nPatients were divided into:\n\nGroup 1=\\>ETT (Endo tracheal group) (50 patients) Group 2=\\>LM-S (Laryngeal mask Supreme) (50 patients) Patients and surgeons performing the operation were not aware of which airway device was used. The patients in the groups were determined by block randomized methods.\n\nPatients taken to the surgical room were given standard monitoring (non-invasive blood pressure measurements, electrocardiogram, and peripheral oxygen saturation measurements) before anesthesia induction. For preoperative sedation 0.02 mg/kg midazolam IV was administered.\n\nPatients were preoxygenated with 6 L/min oxygen for 3 minutes through a face mask.\n\nFor anesthesia induction after 2 minutes of 0.2 µg/kg/min remifentanil and 6 mg/kg/hr propofol infusion, IV 1-2 mg/kg propofol , 0,5 mg/kg rocuronium bromide was administered. After induction patients were ventilated with 6 L/min 100% oxygen through a face mask.\n\nAirway devices were inserted by two researchers with more than 5 years experience.\n\nAnesthetic maintenance was provided by 50% O2/air mixture with 0.1-0.4 µg/kg/min remifentanil and 50-150 µg/kg/hr (3-9 mg/kg/hr) propofol IV infusion (24).\n\nBefore LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient\'s body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nAfter LM-S placement the cuff was inflated with air so as to have a pressure below 60 water of centimeter (cmH20) (cuff pressure manometer, Rusch, Germany). Two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal, cuff pressure was measured repeatedly and recorded. At the same time intervals in the ETT group, ETT cuff pressure was measured.\n\nIn the ETT group for women no. 7-7.5 tube was used. The ETT cuff was inflated until the leak sound ceased. It was measured with a manometer to remain between 20-30 water of centimeter (cmH20).\n\nSuccessful placement of LM-S or ETT was confirmed by square-shaped waves observed on the capnogram, easy ventilation of the respiration balloon and visible chest movements. After successful placement of the airway device, it was covered to prevent observation of which device was used.\n\nThe length of time for successful placement (duration from mouth opening to first successful ventilation), number of tries, and ease of placement were recorded. Ease of placement was evaluated by the anesthetist in charge of the airway as easy, hard or unsuccessful (alternative airway management).\n\nIn a situation where airway provision was unsuccessful after 3 tries, patients without placement of LM-S or who could not be intubated were switched to the other group and airway management was provided.\n\nFor oropharyngeal leak test after the expiratory valve was closed air was shut off, O2 was reduced to 3 L/min and the first pressure value when a leak sound was heard was recorded as the oropharyngeal leak pressure. To prevent exposure of the lungs to barotrauma, when the peak inspiratory pressure reached 40 cmH2O the expiratory valve was opened and the test was concluded. This test was repeated before peritoneal insufflation, 10 minutes later and immediately before desufflation and was completed by a researcher blind to the type of airway device inserted.\n\nPositive pressure respiration was begun by using a ring system, 2-4 L/min fresh gas flow and 0.5 fraction of inspired oxygen (FiO2) volume controlled 6-8 ml/kg tidal volume and 10 respirations/min frequency. PEEP was not administered and I:E ratio was adjusted to 1:2. ETCO2 was held between 35-45 mmHg, if necessary first respiration frequency was increased then tidal volume was increased. Permission was given for CO2 insufflation for the laparoscopic intervention with peritoneal interior pressure of 15 mmHg.\n\nTwo minutes after LM-S or ETT placement, before insufflation, 10 minutes after insufflation and trendelenburg position, immediately before peritoneal desufflation and before airway device removal, ventilation parameters were evaluated.\n\nRespiratory measurements to be recorded: Tidal volume (TV), respiration number (RN), peripheral oxygen saturation (SPO2), end-tidal carbon dioxide pressure (PETCO2), peak airway pressure (P peak), mean airway pressure (P mean) and expiration volume per minute (VE).\n\nHemodynamic measurements to be recorded: (simultaneous to the measurements above and additionally before induction) Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP) and heart rate (HR).\n\nEvaluation related to gastric tube:\n\nImmediately after airway device placement using either the LM-S drainage tube or in intubated patients using a 14 Ch orogastric probe within the airway, the stomach was reached and the gastric contents were aspirated. Ease of placement and amount of fluids aspirated were recorded. Ease of placement was classified by the person who inserted the orogastric probe as very easy, easy, difficult and very difficult.\n\nImmediately after the intra-abdominal laparoscopic intervention and immediately before peritoneal insufflation was ended, gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field) and the difference between the scores at the start and end of the operation was recorded .\n\nWhen the patient cooperated LM-S or ETT was removed and total anesthesia duration and peritoneal insufflation duration was recorded. Possible complications that could develop during airway device removal (coughing, vomiting, laryngeal stridor, laryngeal spasm or requirement for airway intervention) were recorded.\n\nAfter LM-S removal the presence of blood was evaluated as\n\n1. no blood\n2. trace amounts of blood\n3. clear amount of blood Revived patients were taken to the recovery unit and a blind researcher evaluated the patients\' throat pain, hoarseness and presence of difficulty swallowing in the 1st and 24th hours. To evaluate throat pain the visual analogue scale was used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA classification group I-II\n* Between 18-65 years\n* Undergoing elective laparoscopic gynecological surgery\n\nExclusion Criteria:\n\n* Individuals with any neck and upper respiratory pathology\n* Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)\n* Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)\n* Obese patients (BMI \\>35)\n* Individuals with sore throat, dysphagia and dysphonia\n* Individuals with possibility or history of difficult airway\n* Operation time planned for more than 4 hours'}, 'identificationModule': {'nctId': 'NCT02127632', 'briefTitle': 'Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery', 'orgStudyIdInfo': {'id': '533-GOA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group ETT (endo tracheal tube)', 'description': 'Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482', 'interventionNames': ['Device: Endotracheal Tube']}, {'type': 'EXPERIMENTAL', 'label': 'Group LM-S(Laryngeal mask supreme Group)', 'description': 'Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.', 'interventionNames': ['Device: Laryngeal Mask Airway-Supreme']}], 'interventions': [{'name': 'Endotracheal Tube', 'type': 'DEVICE', 'otherNames': ['Device: Endotracheal Tube (ETT)'], 'description': 'ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482', 'armGroupLabels': ['Group ETT (endo tracheal tube)']}, {'name': 'Laryngeal Mask Airway-Supreme', 'type': 'DEVICE', 'otherNames': ['Group LM-S (laryngeal mask group).'], 'description': "Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson \\& Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \\<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.\n\nOther Names:\n\nLM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7", 'armGroupLabels': ['Group LM-S(Laryngeal mask supreme Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35320', 'city': 'Izmi̇r', 'state': 'Narlıdere', 'country': 'Turkey (Türkiye)', 'facility': 'Sule Ozbilgin'}], 'overallOfficials': [{'name': 'BAHAR KUVAKİ, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anaesthesiology and Reanimation', 'investigatorFullName': 'Sule Ozbilgin', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}