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CTRI Number  CTRI/2025/08/092303 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the effects of two breathing tubes used during surgery under anaesthesia- Blockbuster and Protector in patients undergoing surgeries 
Scientific Title of Study   Comparison of fiberoptic guided tracheal intubation through Blockbuster and Protector laryngeal mask airway 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ABHISHEK 
Designation  Junior resident  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  08219179076  
Fax    
Email  mandyalabhishek334@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dheeraj kapoor  
Designation  Professor  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121459  
Fax    
Email  kapoor.dheeraj72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manpreet Singh  
Designation  Professor  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh Chandigarh CHANDIGARH 160030 India 
 
Primary Sponsor  
Name  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh Chandigarh CHANDIGARH 160030 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Abhishek   Government medical College and Hospital   Department of Anaesthesia and Intensive Care, Block D,Level 5,GMCH, Sector 32-B, Chandigarh, Pin code-160030 CHANDIGARH
Chandigarh
CHANDIGARH 
9805200733

mandyalabhishek334@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh)  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 laryngeal mask airway   The supraglottic airway device (LMA Blockbuster) will be inserted after induction and neuromuscular blockade to secure the airway. The hemodynamic parameters (MAP and HR) at 1 minute (T1), 5 minutes (T5) after establishing the airway. Once the surgery is complete, the patient will be reversed, and the supraglottic airway device will be removed. Patients will then be monitored Intervention / Comparator Agent for postoperative complications such as sore throat, dysphagia, and dysphonia in the PACU/ward at 30 min, 1 hr.  
Comparator Agent  Protector laryngeal mask airway   The supraglottic airway device (LMA Protector) will be inserted after induction and neuromuscular blockade to secure the airway. The hemodynamic parameters (MAP and HR) at 1 minute (T1), 5 minutes (T5) after establishing the airway. Once the surgery is complete, the patient will be reversed, and the supraglottic airway device will be removed. Patients will then be monitored Intervention / Comparator Agent for postoperative complications such as sore throat, dysphagia, and dysphonia in the PACU/ward at 30 min, 1 hr. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age between 18 to 60 years of either gender.2. Patients with American Society of Anaesthesiologist (ASA) physical status class I and II.
3.Patients undergoing elective surgery requiring controlled ventilation under general
anaesthesia 
 
ExclusionCriteria 
Details  1.Patient with anticipated difficult airway
2. Patient with BMI More than 35 kg per metre square
3. Pregnant women
4. Major maxillofacial trauma or c-spine injury
5. Severe Respiratory, cardiovascular, Renal, hepatic or masculoskeletal disease
6. Severe coagulopathy or h/o anticoagulant use
7. Patient at increased risk of pulmonary aspiration such as GERD and peptic ulcer disease patients
8. Surgery in prone position
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the time taken for fiberoptic-guided endotracheal intubation through the
Blockbuster and Protector laryngeal mask airway.
 
Time from
insertion of the fiberoptic bronchoscope into the respective SAD device until the first square
form capnography trace obtained on the monitor 
 
Secondary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure   ) immediately b) 5 minutes after
insertion 
Comparison of first attempt success rate,ease of insertion and number of attempts of Blockbuster and Protector laryngeal mask airway   After establishment of an effective airway 
To compare total time taken for fiberoptic-guided tracheal Intubation through Blockbuster and Protector laryngeal mask airway   After establishment of an effective airway  
To compare any specific difficulty observed during fiberoptic-guided tracheal Intubation through Blockbuster and Protector laryngeal mask airway    
Fiberoptic grading of the laryngeal view through the study device    
Intraoperative hemodynamic monitoring (NIBP,SPO2,HR,ETCO2)  Preop, Just before insertion, immediately after establishment of an effective airway, 5 minutes after establishment  
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   13/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="5" 
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 increasingly used in anaesthesia, critical care, and emergencies due to their ease of insertion and faster placement compared to endotracheal tubes (ETTs). They are also being used as conduits for ETT placement, offering benefits like reduced hemodynamic response and fewer complications. Among SADs, the LMA Blockbuster and LMA Protector are newer second-generation devices designed to aid intubation. The Blockbuster features a dual cuff and a preformed tube for better sealing and easier insertion, while the Protector has dual gastric drainage channels and a fixed curved shape. Although studies have compared these devices individually or with others, no direct comparison has been made between the Blockbuster and Protector for fiberoptic-guided intubation. This study hypothesizes that the Blockbuster may allow faster intubation due to its ergonomic design and dedicated ETT.
AIM
• Comparison of fiberoptic-guided tracheal intubation through Blockbuster and Protector
laryngeal mask airway.
PRIMARY OBJECTIVES
• To compare the time taken for fiberoptic-guided endotracheal intubation through the
Blockbuster and Protector laryngeal mask airway.
SECONDARY OBJECTIVES
• To compare the total time taken, the ease, number of attempts and any specific difficulties
observed during fiberoptic-guided endotracheal intubation through the two devices.
• To compare the fiberoptic assessment score of the glottic view, first attempt success rate of
ETI, oropharyngeal leak pressure (OLP).
• To compare the number of attempts required for insertion of the device, ease of insertion,
the insertion time and any postoperative adverse events with the two devices.

Methodology 
Participants will be randomly assigned to either the Blockbuster group or the Protector 
group.The study protocol outlines thorough pre anaesthesia workup including physical
examinations, various tests and assessment of difficult airway. Patients will be advised on fasting
and will be pre-medicated according to institutional guidelines. During anesthesia induction,
standard procedures will be followed, including pre-oxygenation, induction with propofol and
neuromuscular blockade. Airway management will vary based on group allocation, either with a
LMA Protector or LMA Blockbuster with specific
techniques outlined for each. Monitoring parameters, including hemodynamic parameters , will be closely observed at designated time points pre and
post-insertion of the airway devices. Analgesics and anti-emetics will be administered as necessary,
and reversal agents will be used post-surgery. The study will also evaluate the post-operative
complications like sore throat, dysphagia and dysphonia.
Outcomes 
1. Time taken for insertion of the endotracheal tube-
2. Oropharyngeal leak pressure a) immediately ___________ b) 5 minutes after
insertion______________
3. Ease of insertion [5-point Likert scale of difficulty (very difficult-1, difficult-2, neutral-3,
easy-4 and 5-very easy)]-
4. Number of attempts at successful insertion–
5. Time taken for insertion of SAD –
6. Total time taken from insertion of SAD until endotracheal tube insertion-
7. Fiberoptic grading of the laryngeal view through the study device –
8. Intraoperative hemodynamic monitoring 

9 Any intraoperative complication:
a) Device displacement
b) Soft tissue oedema
c) Dental trauma
10.Blood stain on study device immediately after removal-
11. Post-operative observations: All patients will be evaluated in the post-anaesthesia care unit
for following:
a) Sore throat in post anaesthesia care unit (none, mild, moderate or severe)
b) Stridor or hoarseness
c) Any other relevant complication 
 
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