Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT01858467
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2013-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supreme LMA and Endotracheal Intubation Use in Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 920}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2013-04-07', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First attempt insertion success rate', 'timeFrame': '1 hour', 'description': "An attempt is defined as insertion and complete withdrawal of the device from the patient's airway"}], 'secondaryOutcomes': [{'measure': 'Time to effective airway placement', 'timeFrame': '1 hour', 'description': 'Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide wave form'}, {'measure': 'Aspiration', 'timeFrame': '1 hour', 'description': 'Signs of aspiration as evidenced by perioperative hypoxemia, wheezing or crepitations upon auscultation of lungs or postoperative dyspnea with chest x ray signs of aspiration'}, {'measure': 'blood on SLMA on removal', 'timeFrame': '1 hour', 'description': 'inspection for presence of blood on Supreme Laryngeal Mask Airway on removal'}, {'measure': 'Sore Throat', 'timeFrame': '1 hour', 'description': 'Sore throat present in the postanaesthesia care unit'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 hour', 'description': 'Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)'}, {'measure': 'Regurgitation', 'timeFrame': '1 hour', 'description': 'Gastric contents identified in the mouth with pH less than 4'}, {'measure': 'Seal pressure', 'timeFrame': '1 hour', 'description': 'Recorded by closing the adjustable pressure limiting valve and insufflating the closed breathing system with 3L/min fresh gas flow. The peak circuit airway pressure achieved was recorded.'}, {'measure': 'Gastric aspirate', 'timeFrame': '1 hour', 'description': 'Volume of gastric aspiration using gastric tube and pH of gastric aspirate using litmus paper'}, {'measure': 'Neonatal outcomes', 'timeFrame': '1 hour', 'description': 'Neonatal birthweight. APGAR score. Umbilical venous cord pH.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Airway, Cesarean'], 'conditions': ['Complications; Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '31286883', 'type': 'DERIVED', 'citation': 'Yao WY, Li SY, Yuan YJ, Tan HS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2019 Jul 8;19(1):123. doi: 10.1186/s12871-019-0792-9.'}]}, 'descriptionModule': {'briefSummary': 'The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.\n\nThe primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.', 'detailedDescription': 'We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 50 years old\n* ASA 1 or 2\n* Fasted at least 6 hours\n* Weight 40 to 75kg\n* Normal airway assessment\n* Singleton term pregnancy (\\>36weeks)\n* Elective Caesarean section\n\nExclusion Criteria:\n\n* In labour\n* Body mass index \\>35\n* Difficult airway (Mallampati 4 or abnormal airway assessment)\n* Gastrooesophageal reflux disease'}, 'identificationModule': {'nctId': 'NCT01858467', 'briefTitle': 'Supreme LMA and Endotracheal Intubation Use in Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': "QuanZhou Women and Children's Hospital"}, 'officialTitle': 'Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2012-10-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supreme Laryngeal Mask Airway', 'description': 'Supreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.', 'interventionNames': ['Device: Supreme Laryngeal Mask Airway']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endotracheal Intubation', 'description': 'Endotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.', 'interventionNames': ['Device: Endotracheal intubation']}], 'interventions': [{'name': 'Endotracheal intubation', 'type': 'DEVICE', 'description': 'Portex endotracheal tube 6.5mm or 7.0mm internal diameter', 'armGroupLabels': ['Endotracheal Intubation']}, {'name': 'Supreme Laryngeal Mask Airway', 'type': 'DEVICE', 'description': 'Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.', 'armGroupLabels': ['Supreme Laryngeal Mask Airway']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shi Y Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Quanzhou Women's and Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Yu Yao', 'class': 'OTHER'}, 'collaborators': [{'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Wei Yu Yao', 'investigatorAffiliation': "QuanZhou Women and Children's Hospital"}}}}