Influence of Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster
Determining the Influence Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster During Surgery.
1 other identifier
observational
66
1 country
1
Brief Summary
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. One 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. However 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. In 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2024
CompletedFebruary 6, 2024
February 1, 2024
3 months
October 16, 2023
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
POGO SCORE
Grading the placement of LMA blockbuster through Fibreoptic Bronchoscope score of at the start and end of the surgery.
IMMEDIATELY AFTER LMA PLACEMENT AND AT THE END OF SURGERY JUST BEFORE REMOVAL OF LMA
Secondary Outcomes (1)
GASTRIC TUBE INSERTION SUCCESS RATE
within 2 minutes of LMA Blockbuster placement
Interventions
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.
Eligibility Criteria
The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.
You may qualify if:
- ASA Grade I \& II patients
- Age between 20-70 years
- Weight between 40-70 kg
- Patients of both sexes
- All classes of MP Grades
You may not qualify if:
- Any pathology of the oral cavity that may obstruct the insertion of device
- Mouth opening less than 2.5cm.
- Potentially full stomach patients (trauma, morbid obesity, history of gastric regurgitation and heart burn, full term pregnancy)
- risk of oesophageal reflux (hiatus hernia)
- Bleeding disorder
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jawaharlal Nehru Medical College
Aligarh, Uttar Pradesh, 450331, India
Related Publications (1)
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.
PMID: 12032052RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MUAZZAM HASAN, MD
AMU
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assitant Professor
Study Record Dates
First Submitted
October 16, 2023
First Posted
October 27, 2023
Study Start
October 30, 2023
Primary Completion
February 3, 2024
Study Completion
February 5, 2024
Last Updated
February 6, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
Patient particulars, PAC sheets and informed consent.