Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-30 @ 4:26 AM
Study NCT ID:
NCT06103968
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POGO SCORE', 'timeFrame': 'IMMEDIATELY AFTER LMA PLACEMENT AND AT THE END OF SURGERY JUST BEFORE REMOVAL OF LMA', 'description': 'Grading the placement of LMA blockbuster through Fibreoptic Bronchoscope score of at the start and end of the surgery.'}], 'secondaryOutcomes': [{'measure': 'GASTRIC TUBE INSERTION SUCCESS RATE', 'timeFrame': 'within 2 minutes of LMA Blockbuster placement', 'description': 'Ease and success rate of gastric tube insertion; number of attempts taken if successfull'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '12032052', 'type': 'RESULT', 'citation': 'Brimacombe J, Vosoba Judd D, Tortely K, Barron E, Branagan H. Gastric tube-guided reinsertion of the ProSeal laryngeal mask airway. Anesth Analg. 2002 Jun;94(6):1670. doi: 10.1097/00000539-200206000-00062. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Since its invention in 1981 by Dr. Archie Brain, the classical laryngeal mask airway (LMA ) has undergone many modifications. Today various LMAs are available that can also help in Ryle's tube insertion, intubation via LMA, deep extubation, adjunct in difficult airway and for spontaneous ventilation in short procedures.\n\nOne of the newer modifications is the Blockbuster LMA. It was invented by Prof. Ming Tian, the president of Chinese Difficult Airway Society and is being increasingly used for cases of difficult intubation. It has some unique features like its 95 degrees angulated airway that makes it easier to insert. It also has a gastric port and provides better sealing pressures at lower volumes.\n\nHowever the one of the major concern with supraglottic airway is that despite correct placement it may dislodge, or its position may change intraoperatively especially in surgeries where patient position needs to be changed or patient is moved/transferred or head and neck surgeries.\n\nIn this study investigator wishes to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.", 'detailedDescription': 'Following approval by the Board of studies, Department of anaesthesiology and ethical committee of this institution the study will be conducted in J N Medical College and hospital on 60 patients undergoing operative procedures under general anaesthesia. Patients will be included in the study after well informed written consent, including the information that they would be part of this ongoing institutional research.\n\nSTUDY DESIGN Prospective randomised controlled study\n\nSTUDY POPULATION The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.\n\nIn this study investigator wishes to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Grade I \\& II patients\n* Age between 20-70 years\n* Weight between 40-70 kg\n* Patients of both sexes\n* All classes of MP Grades\n\nExclusion Criteria:\n\n* Any pathology of the oral cavity that may obstruct the insertion of device\n* Mouth opening less than 2.5cm.\n* Potentially full stomach patients (trauma, morbid obesity, history of gastric regurgitation and heart burn, full term pregnancy)\n* risk of oesophageal reflux (hiatus hernia)\n* Bleeding disorder\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06103968', 'briefTitle': 'Influence of Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster', 'organization': {'class': 'OTHER', 'fullName': 'Aligarh Muslim University'}, 'officialTitle': 'Determining the Influence Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster During Surgery.', 'orgStudyIdInfo': {'id': 'LMA Blockbuster'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LMA BLOCKBUSTER', 'type': 'DEVICE', 'otherNames': ['GASTRIC TUBE'], 'description': 'In this study we wish to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '450331', 'city': 'Aligarh', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Jawaharlal Nehru Medical College', 'geoPoint': {'lat': 27.88145, 'lon': 78.07464}}], 'overallOfficials': [{'name': 'MUAZZAM HASAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient particulars, PAC sheets and informed consent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aligarh Muslim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assitant Professor', 'investigatorFullName': 'MUAZZAM HASAN', 'investigatorAffiliation': 'Aligarh Muslim University'}}}}