| CTRI Number |
CTRI/2023/06/054017 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of using a LMA Gastro Airway in patients when undergoing examination for gallbladder and pancreatic diseases |
|
Scientific Title of Study
|
Comparison of the use of LMA Gastro Airway versus sedation and oxygen supplementation with nasal cannula in patients undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective Randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suruchi |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of medical science |
| Address |
Department of Anaesthesiology,First Floor, A Block, Sanjay Gandhi
Post Graduate Institute of Medical Sciences, Rae Bareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9786025292 |
| Fax |
|
| Email |
suruchi0904@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suruchi |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of medical science |
| Address |
Department of Anaesthesiology,First Floor, A Block, Sanjay Gandhi
Post Graduate Institute of Medical Sciences, Rae Bareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9786025292 |
| Fax |
|
| Email |
suruchi0904@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghna |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anesthesiology, First Floor, A Block, Sanjay Gandhi
Post Graduate Institute of Medical Sciences, Rae Bareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8006333393 |
| Fax |
|
| Email |
meghnaanandaju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences
Raebareli Road
lucknow, Uttar Pradesh 226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Rae Bareli Road, Lucknow, Uttar Pradesh, 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Suruchi |
Sanjay Gandhi PostGraduate Institute of Medical Sciences |
Department of Gastroenterology, ERCP Room,SGPGIMS
Raebareli Road
Lucknow
UTTAR PRADESH |
9786025292
suruchi0904@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Institutional practice |
The patient is sedated deeply and nasal cannula is put for oxygenation and patient lies in prone/semiprone position |
| Intervention |
Using a LMA Gastro Airway for
Endoscopic Retrograde
Cholangiopancreaticography |
LMA Gastro Airway is a
dedicated device to perform
Endoscopic Retrograde
Cholangiopancreaticography.
We aim to use it during ERCP procedure which usually lasts for 45-60 minutes and compare
its effectiveness in comparison
to sedation and oxygen supplementation with nasal cannula which has been used conventionally
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III
Elective procedure
Patients with BMI less than 30
Adequate fasting |
|
| ExclusionCriteria |
| Details |
Patients unable (legally incompetent) or unwilling to give consent.
ASA IV patients
Patients with MODS and severe comorbidities
Patients with BMI more than 30
Patients with height less than 150cms
Patients in whom Supraglottic Devices are contraindicated.
Patients with neurological or cognitive deficits, anticipated difficult
airway(distorted head and neck anatomy, reduced mouth opening,
history of head and neck cancers and radiotherapy, active GERD,COPD.
Patients with increased risk of aspiration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success rate of completion of Endoscopic
Retrograde Cholangiopancreaticography through LMA Gastro Airway
|
At 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Success rate of insertion of LMA Gastro
2.Success rate of ERCP completion
3.Number of attempts
4.LMA Gastro insertion time
Esophageal visualisation time
5.Comparison of vital parameters
6.Anaesthesiologist satisfaction analysis
Gastroenterologist satisfaction analysis
7.Patient satisfaction analysis
Post procedure recovery
8.Adverse events |
1.Before insertion of endoscope(baseline)
2.At the end of procedure(at 1 hour))
3.At the end of procedure(At 1 hour)
4.Time from picking up LMA Gastro to appearance of capnograph and time from insertion of endoscope to esophageal visualisation(baseline)
5.Throuhout the procedure(every 5 mins)
6.Immediately after completion of procedure(at 1hour)
7. Before discharge from PACU(4 hours)
8.Throughout the procedure and upto patient discharge(baseline and 72 hours) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/07/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an diagnostic and therapeutic intervention in patients with diseases of biliary tract and pancreas. Conventionally, it is performed with the patient in prone/semiprone position under deep sedation which makes it uncomfortable and involves insertion of the endoscope multiple times and cause hypoxia. LMA Gastro Airway is a dedicated supraglottic airway device having separate channels for insertion of the endoscope and performing ventilation with an integrated bite block which help in performance of the procedure. The present study aims to compare the usage of LMA Gastro Airway with the standard institutional practice and recording the various associated parameters during the procedure |