NCT06103968

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

October 16, 2023

Last Update Submit

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.

Also known as: GASTRIC TUBE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

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.

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • MUAZZAM HASAN, MD

    AMU

    PRINCIPAL INVESTIGATOR

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.

Locations