CTRI Number |
CTRI/2025/04/085619 [Registered on: 25/04/2025] Trial Registered Prospectively |
Last Modified On: |
22/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A comparative study to find the effectiveness of igel (Supraglottic device) vs lma blockbuster (Supraglottic device ) as a passage for blind intubation during surgeries under general anesthesia |
Scientific Title of Study
|
A comparative study to evaluate the efficacy of igel vs lma blockbuster as conduit for blind tracheal intubation during general anesthesia |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vignesh Kumar |
Designation |
Junior Resident |
Affiliation |
Jawaharlal Nehru Medical College and Hospital |
Address |
Department of Anesthesiology and Critical Care,
Jawaharlal Nehru Medical College and Hospital,
Aligarh Muslim University.
Aligarh
Uttar Pradesh
Aligarh UTTAR PRADESH 202002 India |
Phone |
9176777767 |
Fax |
|
Email |
drvigneshkumar29@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Qazi Ehsan Ali |
Designation |
Professor |
Affiliation |
Jawaharlal Nehru Medical College and Hospital |
Address |
Department of Anesthesiology and Critical Care,
Jawaharlal Nehru Medical College and Hospital,Aligarh Muslim University
Aligarh
Uttar Pradesh
Aligarh UTTAR PRADESH 202002 India |
Phone |
7417701769 |
Fax |
|
Email |
qaziehsanali@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vignesh Kumar |
Designation |
Junior Resident |
Affiliation |
Jawaharlal Nehru Medical College and Hospital |
Address |
Department of Anesthesiology and Critical Care,
Jawaharlal Nehru Medical College and Hospital
Aligarh
Uttar Pradesh
Aligarh UTTAR PRADESH 202002 India |
Phone |
9176777767 |
Fax |
|
Email |
drvigneshkumar29@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anesthesiology and Critical Care,
Jawaharlal Nehru Medical College and Hospital,
Aligarh Muslim University,
Aligarh,
Uttar Pradesh,
India - 202002 |
|
Primary Sponsor
|
Name |
Department of Anesthesiology and Critical careJNMCHAMUAligarh |
Address |
Department of Anesthesiology and Critical care,
Jawaharlal Nehru Medical College and Hospital,
Aligarh Muslim University,
Aligarh,
Uttar Pradesh
India
202002 |
Type of Sponsor |
Government 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 |
Vignesh Kumar |
JNMCH,AMU |
Department of Anesthesiology and Critical Care. Jawaharlal Nehru Medical College and Hospital, Aligarh, Uttar Pradesh 202002. Aligarh UTTAR PRADESH |
09176777767
drvigneshkumar29@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
igel |
After induction of anesthesia ,igel is inserted to secure the airway and then endotracheal tube is blindly intubated through igel and the time taken to achieve ventilation is measured. |
Intervention |
lma blockbuster |
after muscle relaxation. lma blockbuster is inserted to secure the airway and then endotracheal tube is blindly inserted through lma blockbuster and then the time taken to achieve ventilation is measured. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
asa I and II
Mallampatti grade I and II
Patients undergoing general anesthesia |
|
ExclusionCriteria |
Details |
PATIENT REFUSAL
ASA III AND IV
MP III AND IV
PREVIOUS HISTORY OF FAILED INTUBATION
FULL STOMACH
MOUTH OPENING LESS THAN 3 FINGERS
PREGNANT FEMALE
BMI GREATHER THAN 40 |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Total time taken to achieve ventilation after blind intubation through igel and lma blockbuster |
Time is measured from inserting the igel or lma blockbuster in mouth till the appearance of square wave capnograh after the intubation(at baseline and at 5 minutes) |
|
Secondary Outcome
|
Outcome |
TimePoints |
insertion time taken for igel & lma blockbuster |
time is measured from the insertion of igel or lma blockbuster till the appearance of square wave capnograph in the monitor ( at 5 minutes) |
Ease/ attempts taken for the insertion of igel or lma blockbuster |
measure at 5 minutes after the supraglottic device is in place. |
Time taken for blind intubation through igel & lma blockbuster |
time is measure from the beginning of endotracheal blind intubation till the appearance of square wave capnograph on the moniter after blind intubation(at 10 minutes) |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
08/05/2026 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
For surgeries during general anesthesia securing an adequate airway is of utmost importance . The endotracheal tube which was introduced by McEwen is the most favoured method for maintaining an airway Supraglottic airway devices (SAD) have been used for ventilation as well as for providing conduits to blind or fiberoptic guided endotracheal intubation .SAD should have adequate lumen and length for providing a successful channel for endotracheal tube placement. The I-Gel is a single-use supraglottic airway device which is made up of thermoplastic elastomer and gives a gel-like feel. I-Gel has a broader and short airway conduit allowing the endotracheal tube to easily pass through it. Blockbuster LMA is a second-generation supraglottic device. It is easier to ventilate and intubate through this device, as it has 95 degrees angulated airway. The LMA comes with Blockbuster tube made of silicone and is wire-reinforced for intubation. Previously, studies are available to access the efficacy of various SADs used as a passage for endotracheal intubation.. To the best of our knowledge we could not find any literature comparing the clinical utility of the Blockbuster LMA and the I-gel when used for blind tracheal intubation under general anesthesia. Therefore, this study was undertaken to evaluate the success of Endotracheal Intubation through I- Gel and Blockbuster LMA. |