Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-26 @ 11:54 PM
Study NCT ID:
NCT02037958
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D042883', 'term': 'Choledocholithiasis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Effective Airway', 'timeFrame': 'Baseline', 'description': 'Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation'}], 'secondaryOutcomes': [{'measure': 'Number of attempts taken for successful placement of airway device', 'timeFrame': 'Baseline', 'description': 'Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned'}, {'measure': 'Number of attempts taken for successful placement of gastric tube', 'timeFrame': 'Baseline', 'description': 'Number of attempts needed for successful placement of gastric tube. Correct gastric tube placement was determined by positive suctioning of gastric contents or detection of injected air with epigastric auscultation.'}, {'measure': 'Haemodynamic response to insertion of airway device', 'timeFrame': 'Baseline, 1 min, 5 min', 'description': "Systolic blood pressure and heart rate at 0 min, 1 min, 5 min, starting from the time the face mask was removed from the patient's face."}, {'measure': 'Peak airway pressure during pneumoperitoneum', 'timeFrame': 'Assessed intra-operatively, during the period of pneumoperitoneum', 'description': 'Peak airway pressure recorded during pneumoperitoneum, measured during the surgery'}, {'measure': 'Incidence of post-operative sore throat', 'timeFrame': 'Assessed 1 hr after the surgery, at the Recovery Area', 'description': 'Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr after the end of surgery. No further follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cholecystitis', 'Choledocholithiasis']}, 'descriptionModule': {'briefSummary': 'We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.', 'detailedDescription': 'The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) Physical Status 1 and 2\n* Undergoing elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* BMI \\> 30\n* Known gastro-oesophageal reflux disease\n* predicted or documented difficult airway\n* contraindications to drugs in the standardized anaesthesia protocol'}, 'identificationModule': {'nctId': 'NCT02037958', 'briefTitle': 'Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CGHLMAS2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laryngeal Mask Airway-Supreme', 'description': 'Patients who are randomly assigned to receive the LMA-Supreme', 'interventionNames': ['Device: Laryngeal Mask Airway-Supreme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endotracheal Tube', 'description': 'Patients who are randomly assigned to receive endotracheal intubation', 'interventionNames': ['Device: Endotracheal Tube']}], 'interventions': [{'name': 'Laryngeal Mask Airway-Supreme', 'type': 'DEVICE', 'otherNames': ['LMA-S', 'LMA-Supreme', 'LMA Supreme'], 'description': 'Patients who receive the LMA-S', 'armGroupLabels': ['Laryngeal Mask Airway-Supreme']}, {'name': 'Endotracheal Tube', 'type': 'DEVICE', 'otherNames': ['ETT', 'Tracheal Tube'], 'description': 'Patients who receive endotracheal intubation', 'armGroupLabels': ['Endotracheal Tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Kelvin Quek, MMED (Anaes)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anaesthetist', 'investigatorFullName': 'Kelvin Quek How Yow', 'investigatorAffiliation': 'Changi General Hospital'}}}}