The study of an airway device for performing procedure to see the passage of bile from the liver

Not yet recruiting

• Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

• Registration Number: CTRI/2023/05/053057
• Lead Sponsor: MS Ramaiah Medical College

Brief Summary

Over the years, providing anaesthesia at remotelocations termed as non-operating room anaesthesia has been steadily increasingand endoscopy suite is one such environment. Although most uppergastrointestinal endoscopies are done under conscious sedation, deep sedation orgeneral anaesthesia is preferred for advanced procedures and interventions likeendoscopic retrograde cholangiopancreatography (ERCP).

ERCP is an endoscopic diagnostic and therapeuticprocedure widely used for the management of hepatobiliary and pancreaticdisorders, which is usually done under tubeless anaesthesia or generalendotracheal anaesthesia. Most patients frequently receive tubelessanaesthesia and are found to transition between different depths of anaesthesia. Although, most often safer, significant cardiorespiratory event and hypoxia isknown to occur in a few patients. Central to the occurrence ofsuch events is an unsecured airway. Anaesthesia outside operating room makes upa higher proportion of closed claims resulting in death, than in operating roomcases and an unsecured airway is shown to have a higher incidence of liabilityclaims related to respiratory events.

Clearly, there is a scope to improve airway andventilation management during anaesthesia for upper gastrointestinal endoscopicprocedures. The LMA® Gastro™ Airway (Teleflex Medical, Morrisville,NC) is a new laryngeal mask airway specifically designed for uppergastrointestinal endoscopy by Dr. Skinner. This device has adedicated endoscopy channel (16mm internal diameter), which runs parallel alongthe airway channel with a terminal cuff. The endoscopy channel ends at thecuff’s distal tip to align with the upper esophageal opening. A well lubricatedendoscope can be passed through the channel for endoscopic procedures. Being arecently introduced airway device, there is paucity of literature with respectto its efficacy and this study has not been conducted on Indian population andhence the present study is designed to evaluate its role in ERCP.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-19
• Study Start: 2023-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1.Adults aged 18 years to 70 year 2.American society of anaesthesiologists(ASA) physical status 1 and 2 3.BMI less than 35 kg/m2.

Exclusion Criteria

1.Risk of aspiration 2.Propofol allergy 3.Abnormal head or neck pathology 4.Surgical or radiation treatment to head or neck 5.Esophageal surgery 6.Patients undergoing concurrent endo-ultrasound 7.Anticipated difficult airway 8.Neuromuscular disorders.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the success rate of LMA Gastro Airway for performing ERCP	To determine the success rate of LMA Gastro Airway for performing ERCP 5 minutes after the completion of the procedure

Secondary Outcome Measures

Name	Time	Method
Number of attempts of insertion of the LMA Gastro Airway	5 minutes after successful insertion of LMA Gastro Airway
Oropharyngeal leak pressure of the LMA Gastro Airway device	5 minutes after successful insertion of LMA Gastro Airway

Trial Locations

Locations (1)

MS Ramaiah Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

MS Ramaiah Medical College Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Tejesh C A

Principal investigator

9886481848

drtejeshca@yahoo.com