FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/053057 [Registered on: 23/05/2023] Trial Registered Prospectively
Last Modified On: 19/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   The study of an airway device for performing procedure to see the passage of bile from the liver  
Scientific Title of Study   THE LARYNGEAL MASK AIRWAY GASTRO AIRWAY (LMA®GASTROâ„¢ AIRWAY) FOR SUCCESSFUL COMPLETION OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siri Gangadkar S P 
Designation  PG Resident Anaesthesiology 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore
New BEL Road MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  8971735365  
Fax    
Email  sirigangadkar4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejesh C A 
Designation  Professor  
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore
New BEL Road MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejesh C A 
Designation  Professor  
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore
New BEL Road MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore 560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical College 
Address  New BEL Road MSRIT Post Bangalore 560054 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejesh C A   MS Ramaiah Medical College Hospital  Department of Anaesthsiology Second Floor MS Ramaiah Medical College Hospital New BEL Road Bangalore 560054
Bangalore
KARNATAKA 
9886481848

drtejeshca@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sirigangadkar4@gmail.com].

  6. For how long will this data be available start date provided 08-08-2025 and end date provided 08-08-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Over the years, providing anaesthesia at remote locations termed as non-operating room anaesthesia has been steadily increasing and endoscopy suite is one such environment. Although most upper gastrointestinal endoscopies are done under conscious sedation, deep sedation or general anaesthesia is preferred for advanced procedures and interventions like endoscopic retrograde cholangiopancreatography (ERCP).

ERCP is an endoscopic diagnostic and therapeutic procedure widely used for the management of hepatobiliary and pancreatic disorders, which is usually done under tubeless anaesthesia or general endotracheal anaesthesia. Most patients frequently receive tubeless anaesthesia and are found to transition between different depths of anaesthesia. Although, most often safer, significant cardiorespiratory event and hypoxia is known to occur in a few patients. Central to the occurrence of such events is an unsecured airway. Anaesthesia outside operating room makes up a higher proportion of closed claims resulting in death, than in operating room cases and an unsecured airway is shown to have a higher incidence of liability claims related to respiratory events.

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

 
Close