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:
Aligarh Muslim University
Organization:
Study Overview
Official Title:
Determining the Influence Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster During Surgery.
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
STUDY DESIGN Prospective randomised controlled study
STUDY POPULATION The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.
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.
STUDY DESIGN Prospective randomised controlled study
STUDY POPULATION The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: