Influence of Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster

Sponsor
Aligarh Muslim University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06103968
Collaborator
(none)
60
1
2.8
21.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LMA BLOCKBUSTER

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

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determining the Influence Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster During Surgery.
Anticipated Study Start Date :
Oct 30, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 24, 2024

Outcome Measures

Primary Outcome Measures

  1. POGO SCORE [IMMEDIATELY AFTER LMA PLACEMENT AND AT THE END OF SURGERY JUST BEFORE REMOVAL OF LMA]

    Grading the placement of LMA blockbuster through Fibreoptic Bronchoscope score of at the start and end of the surgery.

Secondary Outcome Measures

  1. GASTRIC TUBE INSERTION SUCCESS RATE [within 2 minutes of LMA Blockbuster placement]

    Ease and success rate of gastric tube insertion; number of attempts taken if successfull

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA Grade I & II patients

  • Age between 20-70 years

  • Weight between 40-70 kg

  • Patients of both sexes

  • All classes of MP Grades

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jawaharlal Nehru Medical College Aligarh Uttar Pradesh India 450331

Sponsors and Collaborators

  • Aligarh Muslim University

Investigators

  • Principal Investigator: MUAZZAM HASAN, MD, AMU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MUAZZAM HASAN, Assitant Professor, Aligarh Muslim University
ClinicalTrials.gov Identifier:
NCT06103968
Other Study ID Numbers:
  • LMA Blockbuster
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 27, 2023