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CTRI Number  CTRI/2024/08/072151 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of two different airways for patient undergoing general anaesthesia 
Scientific Title of Study   Comparison of Laryngeal mask airway Blockbuster and Laryngeal mask airway Supreme in patients undergoing General Anesthesia A Randomised Controlled Trial 
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 Richa Chandra 
Designation  Professor  
Affiliation  Rohilkhand Medical College and Hospital  
Address  Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8279783945  
Fax    
Email  rinkichandra@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Richa Chandra 
Designation  Professor  
Affiliation  Rohilkhand Medical College and Hospital  
Address  Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8279783945  
Fax    
Email  rinkichandra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Indu Gupta 
Designation  Junior resident  
Affiliation  Rohilkhand Medical College and Hospital  
Address  Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9627152159  
Fax    
Email  guptaindu45627@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital 
Address  Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 243006 
Type of Sponsor  Private 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 Richa Chandra   Rohilkhand Medical College and hospital   Room no 2062-D, department of anaesthesia
Bareilly
UTTAR PRADESH 
8279783945

rinkichandra@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,RMCH,Bareilly,U.P.  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  LMA Blockbuster   The Blockbuster LMA is a multiple use device, well-tolerated airway conduit with tracheal intubation capabilities. It enhances the success rate of blind tracheal intubation. Constructed from flexible and biocompatible silicon material, the laryngeal mask includes an inflatable cuff and is connected to the airway tube at an angle exceeding 95 degree. 
Comparator Agent  LMA Supreme   Supreme LMA is a single-use, latex-free device which is made of polyvinyl chloride with gastric access. The firm, elliptical, and anatomically shaped airway tube facilitates easy insertion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Either sex.
BMI less than 26kg/m2
Mallampati classification I & II
ASA- I & II
Age- 18 to 65 years
Adequate head & movement
 
 
ExclusionCriteria 
Details  Anticipated difficult airway
Full stomach patients
Cervical spine instability
Temporomandibular joint pathology
History of gastro-oesophageal reflux or increased risk of Gastric aspiration
Pharyngeal & Laryngeal surgery
Thoracotomy
Lateral or prone surgery position
Pregnant females 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Number of attempts
2. Ease of insertion
3. Airway manipulation
4. Oropharyngeal seal Pressure 5. Post-operative Pharyngolaryngeal Morbidity
6. Ease and time of insertion of gastric tube
7. ETCO2 Graph (Capnography characteristics) 
Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters (Heart rate, systolic & diastolic blood pressure, mean arterial pressure)  Baseline, 5 minutes, 10 minutes, 30 minutes & at the end of surgery 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 4 
Date of First Enrollment (India)   19/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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   General anesthesia is described as a state of "Controlled Unconsciousnes allowing patients to undergo procedures that would be unbearable while awake. Ensuring a secure airway is crucial during general anesthesia to ensure proper ventilation, oxygenation, and administration of anesthetic gases.

The management of the airway is vital in both general anesthesia and resuscitation efforts. Endotracheal intubation, which requires a deeper level of anesthesia and greater expertise, is associated with a higher incidence of postoperative sore throat. In response to this challenge, a significant innovation emerged in 1981 with the introduction of the Laryngeal-mask airway by Dr. Archie Brain.

Supraglottic airway devices have become increasingly prevalent in airway management due to their advantageous anatomical placement and minimally invasive characteristics. These devices serve as a link between traditional face masks and tracheal tubes, positioned above the glottis, eliminating the need to enter the trachea. They provide a hands-free technique for securing the airway, enabling efficient ventilation, oxygenation, and administration of anesthetic gases without the requirement for tracheal intubation.

Supraglottic Airway (SGA) devices offer a more secure airway than a face mask and are less intrusive than tracheal intubation. They can be used for both spontaneous ventilation and Positive Pressure Ventilation. They also offer several advantages, such as rapid and uncomplicated placement, enhancement of hemodynamic stability, reduced anesthesia requirements, elimination of the need for muscle relaxation, and avoidance of certain risks associated with tracheal intubation. These risks include potential harm to teeth and airway structures, the occurrence of a sore throat, emergence-related coughing, and bronchospasm. Additionally, SGA devices offer an enhanced airway seal, achieved through improved seal materials or design, which simplifies intubation by allowing the use of regular endotracheal tubes and incorporates a gastric access port for venting and aspirating stomach contents.

The LMA BLOCKBUSTER, developed by Prof. Ming Tian, is part of the second generation of LMAs. It serves as a well-tolerated airway device with the capability for tracheal intubation. Featuring an intubation channel, it enhances the success rate of blind tracheal intubation while ensuring a secure seal and extended ventilation. Made from flexible and biocompatible silicone material, this laryngeal mask includes an inflatable cuff and is angled over 95 degrees for optimal placement. To ensure safety, a gastric tube can be inserted alongside to prevent gastric reflux and aspiration. It also includes features like an integrated bite block and sputum collection device. Additionally, it comes with an endotracheal tube featuring a Parker pen tip and an exchange guide.

LMA SUPREME is a single-use, latex-free laryngeal mask airway made of medical grade PVC. It combines features from various LMA designs. The device features an inflatable and large plastic cuff without a posterior cuff, an esophageal drain tube, and a pre-formed semi-rigid tube. Fins in the mask bowl help prevent epiglottic obstruction. Its pharyngeal seal is intermediate between cLMA and PLMA, while the oesophageal seal data is not available. The firm, elliptical, and anatomically shaped airway tube allows for easy insertion without requiring fingers in the patient’s mouth or an introducer tool.

Supraglottic airway devices (SADs) are frequently employed as alternatives to both face mask ventilation and tracheal intubation. However, there remains a lack of extensive research regarding the safety and efficacy of SADs like LMA Blockbuster and LMA Supreme. To bridge this knowledge gap, we are proposing a randomized controlled trial to compare the performance of LMA Blockbuster and LMA Supreme in patients undergoing general anesthesia.
 
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