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CTRI Number  CTRI/2025/04/084952 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Blockbuster LMA and Air Q LMA for blind tracheal intubation in patients undergoing elective surgery: A prospective study 
Scientific Title of Study   Prospective study to compare the Blockbuster LMA and the Air Q LMA as a conduit for blind tracheal intubationin patients scheduled for elective surgery under general anaesthesia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranya Singla 
Designation  Anaesthesia Resident 
Affiliation  Maharishi Markandeshwar University 
Address  Department of Anaesthesia, MM institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9158508104  
Fax    
Email  pranya.singla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sapna Bansal 
Designation  HOD and professor 
Affiliation  Maharishi Markandeshwar University 
Address  Department of Anaesthesia, MM institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sapna Bansal 
Designation  HOD and professor 
Affiliation  Maharishi Markandeshwar University 
Address  Department of Anaesthesia, MM institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala, (Haryana) India 133207 
 
Primary Sponsor  
Name  Doctor Sapna Bansal HOD and Professor of Department of Anaesthesia  
Address  HOD and professor of Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala, Haryana, India 133207 
Type of Sponsor  Research institution and hospital 
 
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 Pranya Singla  MM Institute of Medical Sciences and Research Centre  Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, IInd floor,Near OT complex, Old Building , Mullana, Mala , Haryana (India) 133207
Ambala
HARYANA 
9158508104

pranya.singla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Co MMIMSR, mullana, Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Posted for elective surgeries under General Anaesthesia  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Blind tracheal intubation via AirQ LMA  Group B undergoes blind tracheal intubation using an appropriate sized endotracheal tube using AirQ LMA as a conduit 
Intervention  Blind tracheal intubation via Blockbuster LMA  Group A undergoes blind tracheal intubation using an appropriate sized endotracheal tube using Blockbuster LMA as a conduit at the beginning of elective surgery under general anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Either gender of age 18-60 years and ASA grade I and II status with modified Mallampatti grade I,II or III, scheduled for elective surgery under general anaesthesia. 
 
ExclusionCriteria 
Details  1. ASA III and IV
2. Obese patients with BMI >40
3. Anticipated difficult airway (Incisior distance <3cm, MPG grade IV, restricted neck movements)
4. ptients refused to give consent.
5. pregnant females
6. those planned for rapid sequence intubation
7. increased risk of pulmonary aspiration with gastric content
8. patients with complaints of sore throat, oral or laryngeal pathology 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the comparion of successful intubations, time taken for intubation, number of attepmts and post operative complications  Peroperative( baseline), at the time of intubation , 1 min after Endotracheal tube insertion, 3 min after ETT insertionn and 5 min after ETT insertion 
 
Secondary Outcome  
Outcome  TimePoints 
   
to study ease of insertion of ETT via LMA & to detect failure of LMA insertion or ETT insertion.  preoperative(baseline) vitals measurement, intubation via alternate mathods & time taken, post operative vital measurement 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 3 
Date of First Enrollment (India)   27/04/2025 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Airway management remains a vital primary skill for anaesthetist. Rapid placement of a reliable airway is the most important task in anesthesia practice. Airway management is a critical skill to provide safe anesthesia . Airway management in patients undergoing general anesthesia is a set of actions that result in the creation of a safe and secure airway for ventilation. Failure in the airway management and hypoxia can lead to irreversible brain damage within only a few minutes. Therefore, establishing a fast and secure airway is one of the most important tasks of an anesthesiologist.

The main reason for failure in laryngoscopy is the anatomical condition of the patient and the physician’s experience in performing a laryngoscopy. The availability of alternative equipment and methods may increase the success rate for anesthesiologists.

Many devices and instruments have been introduced and used to make intubation an easier and simple technique. In the events of failure to intubate and failure to ventilate, LMA play a critical role. LMA are inserted up to glottic entry via oral route and can be used in conditions when tracheal intubations and mask ventilations are challenging. Over the years, the single-tube supraglottic airway device (SGD) design transformed into dual-lumen intubating conduits and assumed an advanced role in airway management. New SGDs have roles beyond airway maintenance, including airway rescue after failed intubation or failed ventilation.

SGDs are recommended to be used as intubation conduits by Difficult airway society guidelines. With the availability of different intubating SGD designs over the years, it is essential to understand which device serves as a better intubating conduit.

 Blockbuster LMA (Tuoren medical instrument co ltd, Chang yuan city, China) introduced in 2012 by Professor Ming Tian, is designed to provide high airway seal pressures and increased green channel for intubation.(2)

2. Air Q LMA (Cook gas LLC, Mercury Medical, Clearwater, FL, USA) introduced by Daniel Cook in 2005 is a supraglottic airway device with shorter and wider breathing tube designed for ventilation as well as intubation in anticipated as well as unanticipated difficult airway. The design of both these LMAs provide an unobstructed pathway for passage of endotracheal tube by providing favorable alignment with the glottic inlet. It is necessary to assess their safety and their performance . Many authors have studied regarding the utility of blockbuster LMA and Air Q LMA separately. However, there is a paucity in the literature in regards to comparing the above devices in regards to success of endotracheal intubation. Therefore, the purpose of conducting this study is to compare the efficacy of blind endotracheal intubation through Blockbuster and Air Q LMA in terms of successful tracheal intubation, time taken for intubation, number of attempts and post operative complications associated.

 
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