Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02852135
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2016-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2016-04-16', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group', 'timeFrame': 'intraoperative', 'description': 'The equilibrating airway pressure was recorded when an audible leak occurred over the mouth.'}], 'secondaryOutcomes': [{'measure': 'Ventilatory efficiency scores for the LMAs', 'timeFrame': 'intraoperative'}, {'measure': 'Adverse effects in two groups', 'timeFrame': 'intraoperative', 'description': 'The adverse effects including regurgitation,hypoxemia,dysphonia,blood stained after LMA removal, and postoperative sore throat.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laryngeal Mask Airway', 'lateral position', 'laparoscopic surgery'], 'conditions': ['Urologic Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.', 'detailedDescription': 'We undertook a single-blind, parallel-group, randomized controlled trial.The patients were randomized to either LMA Proseal group or LMA Supreme group by computer generated allocation.\n\nThe patients were scheduled for elective lateral positioned laparoscopic surgery, such as laparoscopic radical nephrectomy, laparoscopic renal cyst decortication (LRCD) or laparoscopic adrenalectomy.Inclusion criteria for the patients were: Aged\\>18 years, ASA physical status grade I - Ⅲ and body mass index ≤30 kg.m-2. Exclusion criteria were: anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position.\n\nExclusion Criteria:\n\n* The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.'}, 'identificationModule': {'nctId': 'NCT02852135', 'briefTitle': 'Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeries', 'orgStudyIdInfo': {'id': 'LMA-lateral-laparoscopic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMA Proseal group', 'description': 'The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Prosealgroup,LMA Proseal was inserted into each patient after anesthesia induction.', 'interventionNames': ['Device: LMA Proseal']}, {'type': 'EXPERIMENTAL', 'label': 'LMA Supreme group', 'description': 'The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Supreme group,LMA Supreme was inserted into each patient after anesthesia induction.', 'interventionNames': ['Device: LMA Supreme']}], 'interventions': [{'name': 'LMA Proseal', 'type': 'DEVICE', 'description': 'After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.', 'armGroupLabels': ['LMA Proseal group']}, {'name': 'LMA Supreme', 'type': 'DEVICE', 'description': 'After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ，LMA Supreme was inserted and cuff inflated in each group.', 'armGroupLabels': ['LMA Supreme group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Liu Yi, D.M', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sheng Lan', 'investigatorAffiliation': 'Changhai Hospital'}}}}