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CTRI Number  CTRI/2025/09/094048 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 31/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two breathing devices mainly Blockbuster LMA and I-gel used during planned surgeries under general anesthesia, to see how well they work when patients head and neck are placed in different positions 
Scientific Title of Study   Comparison of two Supraglottic airway devices for efficacy of ventilation in different head and neck positions in patients undergoing elective surgery under 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  Dr Natasha Boro 
Designation  Post Graduate Resident 
Affiliation  VVMC and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Safdarjung Hospital Campus, Ansari Nagar West, Delhi

South West
DELHI
110029
India 
Phone  8471979940  
Fax    
Email  tashaboro006@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi Agrawal 
Designation  Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Safdarjung Hospital Campus, Ansari Nagar West, Delhi

South West
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Agrawal 
Designation  Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Safdarjung Hospital Campus, Ansari Nagar West, Delhi

South West
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital 
 
Primary Sponsor  
Name  VMMC and Safdarjung Hospital 
Address  Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi 
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 
Dr Natasha Boro  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anesthesiology and Intensive Care, Main OT building, ground floor, Safdarjung Hospital Campus, Ansari Nagar East
South West
DELHI 
8471979940

tashaboro006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Protocol Review Committee  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 
Intervention  Blockbuster LMA for efficacy of ventilation in different head and neck positions in patients undergoing elective surgery under general anaesthesia  Comparison of blockbuster LMA with i-gel for efficacy of ventilation in different head and neck positions of neutral, 20 degree flexion, maximum extension and maximum right lateral position in random order 
Comparator Agent  I-gel for efficacy of ventilation in different head and neck positions in patients undergoing elective surgery under general anesthesia  Comparison of Blockbuster LMA with I-gel for efficacy of ventilation in different head and neck positions of neutral, flexion, extension and lateral rotation in patients undergoing elective surgery under general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients in the age group of 18-65years of either gender belonging to ASA I-II undergoing elective surgery under general anaesthesia 
 
ExclusionCriteria 
Details  1. Patients with anticipated difficult airway
2. Pathology of neck and cervical spine
3. Body mass index more than 35kg per meter square
4. Intrinsic lung disease
5. Patients at high risk of aspiration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare oropharyngeal seal pressure of Blockbuster Laryngeal Mask Airway with i-gel in different head and neck positions in patients undergoing elective surgery under general anaesthesia  Oropharyngeal seal pressure will be noted in neutral position and after 1 minute of each position change of head and neck such as 20 degree flexion, maximum extension and maximum right lateral position 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following insertion characteristics of Blockbuster laryngeal mask airway with i-gel in patients undergoing elective surgery under general anaesthesia
1. Number of attempts taken for successful insertion of device
2. Time for achieving effective ventilation
3. Anatomical alignment of device with glottis opening ( Brimacombe score), Peak Inspiratory Pressure (PIP), Leak percent, OSP-PIP and ventilation score in different head and neck positions 
Each parameters will be noted in neutral position and after 1 minute of each position change of head and neck 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   15/09/2025 
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)   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  

Supraglottic airway devices (SADs) are widely being used for airway management in patients undergoing elective surgery for offering safer alternative in terms of more hemodynamic stability and lesser postoperative respiratory complications as compared to endotracheal intubation. Securing airway during difficult airway scenario is a vital part for patient’s oxygenation and ventilation. SADs are being progressively redesigned to improve oropharyngeal seal pressure, semblance with airway anatomy for ease of device insertion and success rate for blind endotracheal intubation. 

Oropharyngeal seal pressure achieved by SADs holds due importance as it indicates the feasibility of positive pressure ventilation, the degree of airway protection from supra-cuff soiling and also relates to postoperative morbidity. Although, SADs are known to offer good seal, ventilation through SADs can be affected by change in head and neck positions required in various surgeries of head and neck for proper visualization of surgical field due to alteration of pharyngeal volume and shape.

In this study we will compare Blockbuster Laryngeal Mask Airway with I-gel for efficacy of ventilation in different head and neck positions in patients of age group 18-65 years belonging to ASAI-II undergoing elective surgery under general anesthesia.

The methodology and procedure of study will be explained to the patient and informed written consent will be taken. A computer generated random number table will be used to allocate patients in 2 groups ( group A and group B). Allocations will be concealed in sealed numbered opaque envelops, where group A represents Blockbuster LMA and group B represents i-gel.

Patients will be taken to the operation theatre, monitors attached and baseline vitals noted. After preoxygenation with 100 percent oxygen, induction with inj. Fentanyl, inj. Propofol and muscle relaxant and IPPV for 3mins, group A will be intubated with Blockbuster LMA and group B with i-gel respectively.

After confirmation of achieving effective ventilation, neutral position of head and neck will be made and parameters will be noted.

Thereafter, the position of head and neck will be changed from neutral to 20 degree flexion, maximum extension and maximum right lateral position in random order and parameters will be noted in neutral position and after 1 minute of each position change of head and neck.

Parameters to be noted are as follows

1. Number of attempts taken for successful insertion of device, time for achieving effective ventilation and ease of insertion of device

2. Oropharyngeal seal pressure (OSP), anatomical alignment of device with glottis opening (Brimacombe score), PIP, OSP-PIP, ventilation score and leak percent in neutral and different head and neck positions.

 

 
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