| CTRI Number |
CTRI/2021/06/034212 [Registered on: 14/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| 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 gastrolaryngeal tube in patients when undergoing examination for diseases of pancreas |
|
Scientific Title of Study
|
Evaluation of Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreaticography: 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 Rudrashish Haldar |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Rae Bareli Road
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9256543256 |
| Fax |
|
| Email |
rudrashish@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudrashish Haldar |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Rae Bareli Road
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9256543256 |
| Fax |
|
| Email |
rudrashish@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshika Dengre |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Rae Bareli Road
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8660573783 |
| Fax |
|
| Email |
anshika95d@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli 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 Rudrashish Haldar |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Anaesthesiology, First Floor,A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH |
9256543256
rudrashish@yahoo.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:K839||Disease of biliary tract, unspecified. Ayurveda Condition: Biliary Tract and Pancreatic Diseases, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Institutiional Practice |
The patient is sedated deeply and turned prone.The endoscope is inserted through a mouth gag |
| Intervention |
Using a gastrolaryngeal tube for Endoscopic Retrograde Cholangiopancreaticography |
Gastrolaryngeal tube is a dedicated device to perform Endoscopic Retrograde Cholangiopancreaticography. We aim to use it and compare its effectiveness in comparison to our standard Institutional practice of keeping the patient on spontaneous ventilation and using a mouth gag |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Elective procedures
Patient with BMI less than 30
Patients with height more than 150cms
|
|
| 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 Gastro-Laryngeal Tube |
After the completion of the entire procedure of endoscopic retrograde cholangiopancreaticography |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate of insertion of Gastrolaryngeal Tube
|
Before insertion of the endoscope |
Success rate of procedures
|
At the end of the procedures |
Number of attempts
|
Before insertion of the endoscope |
Gastrolaryngeal Tube insertion time and esophageal visualization time
|
Time from picking the gastrolaryngeal tube and apperance of capnograph after placement and time from insertion of endoscope to visualization of oesophagus |
Comparison of vital parameters (saturation and hemodynamic)
|
Throughout the procedure |
Anaesthesiologist’s satisfaction analysis and Gastroenterologists satisfaction analysis
|
Immediately after completion of procedure |
Patient’s satisfaction analysis and post procedure recovery along with incidence of sore throat, hoarseness, dysphagia, dysphonia.
|
Before discharge from PACU |
Intra-procedure and post procedure adverse events
|
Throughout the procedure and upto the discharge of the patient |
Duration of time until Aldrete recovery score ≥9
|
During the stay of patient in the post anaesthesia care unit (PACU) |
Total amount of propofol consumed
|
At the end of the procedure |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
15/06/2021 |
| Date of Study Completion (India) |
26/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
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 pancrreas. Conventionally, it is performed with the patient in prone position under deep sedation which makes it uncomfortable and involves insertion of the endoscope multiple times and cause hypoxia. Gastrolaryngeal tube 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 Gastrolaryngeal tube with the standard institutional practice and recording the various associated parameters during the procedure |