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®GASTRO™ 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
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sirigangadkar4@gmail.com].
- 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.
- 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. |