Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 11:47 PM
Study NCT ID:
NCT03139292
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized single blinded parallel group controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-25', 'studyFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate for the first attempt at insertion', 'timeFrame': '5 minutes', 'description': 'A failed insertion attempt is defined as when removal of the device needed from the mouth.'}], 'secondaryOutcomes': [{'measure': 'Time taken for insertion', 'timeFrame': '5 minutes', 'description': 'Time taken for insertion from picking up the LMA till confirmation of effective ventilation'}, {'measure': 'The number of insertion attempts', 'timeFrame': '5 minutes', 'description': 'The number of insertion attempts or failed attempt to achieve effective ventilation. A failed insertion attempt is defined as when removal of the device needed from the mouth. Three attempts allowed before insertion will be considered a failure.'}, {'measure': 'Intracuff and the oropharyngeal leak pressures after ensuring effective placement.', 'timeFrame': '5 minutes', 'description': 'Intracuff and the oropharyngeal leak pressures after ensuring effective placement. These pressures will be determined by closing the expiratory valve of the circle system at a fresh gas flow of 3 l/min, note the airway pressure (maximum allowed: 40 cm H2O) at which equilibrium was reached.'}, {'measure': 'The time taken for orogastric tube placement', 'timeFrame': '5 minutes', 'description': 'The time taken for correct placement will be recorded, from Picking up the orogastric tube till confirmation of its placement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngeal Masks']}, 'descriptionModule': {'briefSummary': 'Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.', 'detailedDescription': 'The study aims to compare the two devices with respect to:\n\nTime taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2\\< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) Physical Status I \\& II\n2. Patients undergoing limb or breast surgery\n3. Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.\n4. Patients with expected duration of surgery of less than 2 hours.\n\nExclusion Criteria:\n\n1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV\n2. Patients with mouth opening of less than 2.5 cm or cervical spine disease\n3. Patients with H/o upper respiratory tract infection in the previous 10 days.\n4. Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)\n5. Patients with a body mass index (BMI) \\> 30 kg/m2\n6. Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours.\n\n8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions'}, 'identificationModule': {'nctId': 'NCT03139292', 'briefTitle': 'Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway', 'organization': {'class': 'OTHER', 'fullName': 'Tata Main Hospital'}, 'officialTitle': 'Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia', 'orgStudyIdInfo': {'id': '201-26104-152-206580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ProSeal Laryngeal Mask Airway', 'description': 'Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for PLMA insertion', 'interventionNames': ['Device: ProSeal Laryngeal Mask Airway']}, {'type': 'EXPERIMENTAL', 'label': 'AmbuAuraGain Laryngeal Mask Airway', 'description': 'Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for AmbuAuraGain Laryngeal Mask Airway insertion', 'interventionNames': ['Device: AmbuAuraGain Laryngeal Mask Airway']}], 'interventions': [{'name': 'ProSeal Laryngeal Mask Airway', 'type': 'DEVICE', 'description': 'ProSeal Laryngeal Mask Airway was used as the supraglottic device', 'armGroupLabels': ['ProSeal Laryngeal Mask Airway']}, {'name': 'AmbuAuraGain Laryngeal Mask Airway', 'type': 'DEVICE', 'description': 'AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device', 'armGroupLabels': ['AmbuAuraGain Laryngeal Mask Airway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '831001', 'city': 'Jamshedpur', 'state': 'Jharkhand', 'country': 'India', 'facility': 'Tata Main Hospital', 'geoPoint': {'lat': 22.80278, 'lon': 86.18545}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Main Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Dr.Deb Sanjay Nag', 'investigatorAffiliation': 'Tata Main Hospital'}}}}