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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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