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CTRI Number  CTRI/2025/01/079653 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
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   A clinical trial to study the success of vedio guided placement of tube in windpipe using another tube, called Blockbuster and Ambu Auragain in patients with simulated restriction of neck movement. 
Scientific Title of Study   A randomised controlled study to compare the success of fiberoptic guided intubation through Blockbuster LMA VS AMBU Auragain LMA in patients with simulated restriction of neck movement. 
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 NIVEDITHA H 
Designation  PG RESIDENT 
Affiliation  St Johns medical college and hospital 
Address  Department of anaesthesiology Room no 7 OT complex 2nd floor St Johns medical college and hospital Sarjapur road Bengaluru-560034

Bangalore
KARNATAKA
560034
India 
Phone  9591423133  
Fax    
Email  nivedithaharinath1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR DEEPA BASKARAN 
Designation  Associate professor  
Affiliation  St Johns medical college and hospital 
Address  Department of anaesthesiology Room no 7 2nd floor OT complex St Johns medical college and hospital Sarjapur road Bengaluru-560034

Bangalore
KARNATAKA
560034
India 
Phone  9731245827  
Fax    
Email  anesdeepa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Deepa Baskaran 
Designation  Associate professor  
Affiliation  St Johns medical college and hospital 
Address  Department of anaesthesiology,room no 7,2nd floor OT complex,St Johns medical college and hospital.Sarjapur road,Bengaluru-560034

Bangalore
KARNATAKA
560034
India 
Phone  9731245827  
Fax    
Email  anesdeepa@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesiology,St Johns medical college hospital ,sarjapura main road,Bengaluru-560032.Karnataka ,INDIA. 
 
Primary Sponsor  
Name  Department of Anesthesiology St johns medical college 
Address  Department of anesthesiology,St Johns medical college hospital ,sarjapura main road,Bangalore,Karnataka,560034 
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 Niveditha H  St Johns medical college and hospital  Room no.7 ,2nd floor OT complex,sarjapura road, bengaluru -560034
Bangalore
KARNATAKA 
9591423133

nivedithaharinath1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,st johns medical college hospital  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  Blockbuster LMA With Ambu auragain LMA.  .Blockbuster LMA was introduced in 2012 as a new multi-functional intubation LMA It has a short and wide shaft attached to the cuff at an angle 95° to match oropharyngeal curve. It is used as a guidance device that directs specially designed silicon tipped Parker flextube at an angle of 30° to improve successful glottic entry. It Has a small antero-posterior diameter with a large transverse diameter and this creates a large inner lumen reducing the ventilation resistance. It also reduces the (6- 8 mm ID) intubation resistance. Ambu auragain is a Disposable second generation LMA, has Original anatomical curve and fast insertion time. Ambu auragain LMA was introduced in 2013 and has the highest oropharyngeal seal pressure among all SADs it also has a wide shaft attached to the cuff at an angle of 90°. Blockbuster LMA and Ambu auragain LMA are used in routine anaesthesia, difficult airway, failed intubation, as a conduit for intubation. Can pass upto 8.0 size ET tube. 
Intervention  Fibreoptic guided intubation through Blockbuster LMA and Ambu auragain LMA  fibreoptic guided intubation through Blockbuster LMA and Ambu auragain LMA in adult patients with simulated restriction of neck movement using a cervical collar.the duration of this intervention would be around 5 to 10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Adult patients,aged between 18 to 59 years of either sex,belonging to ASA Physical status l and ll ,requiring endotracheal intubation for general anesthesia undergoing elective surgeries will be recruited for the study. 
 
ExclusionCriteria 
Details  1. Patients with BMI >30
2. Anticipated difficult airway (neck pathologies, restriction of mouth opening < 2fb)
3.Hemodynamic instability (ASA III and IV)
4.Patients having contraindication to Supraglottic airways device use (Emergency Surgeries, Full stomach, Aspiration risk, CKD patients, Pregnancy)
5.serology positive patients(HIV,HBsAg,HCV) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Fibreoptic glottic visualization score (BRIMACOMBE BERRY SCORE) and the first pass success rate of fIbreoptic guided intubation through Blockbuster LMA and Ambu Auragain LMA in patients with simulated restriction of neck movements.

 
Outcome (brimacombe berry score ) will be assessed right after LMA is placed and fibreoptic scope is introduced through LMA. FIBREOPTIC GLOTTIC VISUALISATION SCORE
(BRIMACOMBE BERRY SCORE )
1 No cords seen but function is adequate
2 Vocal cords plus anterior epiglottis seen
3 Vocal cords plus posterior epiglottis seen
4 Only vocal cords seen

Success of First pass intubation outcome will be assessed right after fibreoptic guided intubation through LMA
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the proportion of failed to successful SAD placement in each group.
3. To compare the proportion of failed to successful intubation in each group.
2.To compare complications associated like sore throat & hoarseness of voice.

 
1.outcome will be assessed right after SAD placement.if more than two attempts are taken for placement then outcome will be declared as failure.
2.outcome of fibre optic guided intubation will be assessed right after intubation.if more than two attempts are needed for intubation then outcome is declared as failure.
3. Complications like sore throat & hoarseness of voice will be assessed after 1hour & 6hours postoperatively. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/02/2025 
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="2"
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  

INTRODUCTION

In the recent times, Supraglottic airway devices (SADs) have become a Quintessential part of difficult airway management. 

Societal guidelines for difficult airway management have recommended the use of SADs as a conduit for ventilation and subsequent intubation in the “CANNOT INTUBATE CANNOT VENTILATE” step of unanticipated difficult airway algorithm. 

 Since the time of classic Laryngeal mask airway (LMA) was introduced, there are several SADS (mostly II generation SADs) that are introduced with unique design characteristics to improve ventilation and intubation. 

 Blockbuster LMA was introduced in 2012 as a new multi-functional intubation LMA It has a short and wide shaft attached to the cuff at an angle >95° to match oropharyngeal curve. 

It is used as a guidance device that directs specially designed silicon tipped Parker flextube at an angle of 30° to improve successful glottic entry. It Has a small antero-posterior diameter with a large transverse diameter and this creates a large inner lumen reducing the ventilation resistance. It also reduces the (6-8 mm ID) intubation resistance. 

 Ambu auragain  has ttOriginal anatomical curve and fast insertion time. 

Ambu auragain LMA was introduced in 2013 and has the highest oropharyngeal seal pressure among all SADs it also has a wide shaft attached to the cuff at an angle of 90°. 

 Blockbuster LMA and Ambu auragain LMA are used in routine anaesthesia, difficult airway, failed intubation, as a conduit for intubation. Can pass upto 8.0 size ET tube. 

 * In our study, we intend to compare the fibreoptic glottic score (brimacombe berry score) and successful first pass fibreoptic guided intubation through Blockbuster LMA and Ambu auragain LMA in adult patients with simulated restriction of neck movement using a cervical collar. 

 This study would help us to develop a protocol for the department and the right LMA can be standardised for usage in unanticipated difficult airway situation.

NEED FOR STUDY 

Societal guidelines do not recommend any specific SAD for intubation. With more than a dozen second generation SADs in market, it is crucial to use the one which is best suited for a quick and successful intubation in an emergency difficult airway situation. 

 

* The device should be easy to insert and should allow easy and successful fist pass Intubation. A large number of studies are available comparing successful intubation through various SADs with varying success rate(58-91%). 

* However 90% of the studies have compared blind intubation which is not recommended by AIDAA 2018/DAS 2015 guidelines. Very few studies have compared fibreoptic guided intubation through LMAs. 

* There are no studies that have included the clinical performances in a simulated difficult airway setting which is more relatable in real time. Hence, we are comparing Blockbuster LMA and Ambu Auragain LMA use as a conduit for fibreoptic scope guided intubation in a simulated difficult airway setting. 

METHODOLOGY

 * hundred adult patients aged between 18-59 yrs,Of either sex, belonging to ASA physical status I and II, requiring endotracheal intubation for general anesthesia,Undergoing elective surgeries will be recruited for the study. 

     A written informed consent will be taken from patients. Patients will be allocated into either Ambu Auragain group or Blockbuster LMA group using computer generated randomization method.  

* An appropriate size SAD will be chosen based on patient’s weight and the tube size as per manufacturer guidelines. The LMA placement and intubation will be done in the guidance of an anesthesiologist with 5yrs of experience.  

*In the Operation room, standard monitors will be connected and appropriate size Philadelphia collar will be applied. Patients are kept in neutral position and preoxygenated with 100% 02. Patients are induced according to standard general anesthesia protocol. 

* After complete muscle paralysis, the allocated SAD is inserted and cuff is inflated as per manufacturer guidelines, an effective supraglottic airway placement is assessed by adequate chest rise, presence of end tidal CO2 waveform and movement of reservoir bag during ventilation. When more than one insertion attempt is required, the patient will receive bag and mask ventilation between attempts. 

* Failed attempt at insertion of LMA is defined as complete withdrawal of LMA and reinsertion. 

*Failed SAD placement is declared when 2 attempts at insertion fails. Further management is as per the decision taken by attending consultant. 

*After achieving satisfactory ventilation via the allocated SAD, fibreoptic guided tracheal intubation will commence. A fibreoptic scope loaded with a pre lubricated Parker flex tube will be inserted through the LMA once the scope tip reaches the glottic opening, the fibreoptic scoring of glottic view will be assessed using a standardized Brimacombe berry scoring system. 

*The scope will be inserted into the Trachea, the ETT is railroaded into the trachea and the fibreoptic scope is then removed. Proper placement of ETT is confirmed clinically and by presence of end tidal CO2 trace. The SAD is then removed. 

*A maximum of two attempts is allowed with yhi guided intubation.an alternative airway management plan could be instituted at the discretion of anaesthetist if failed intubation was encountered after two attempts with the allocated device. 

 

PARAMETERS ASSESED IN THE STUDY 

 

1.     Glottic visualisation by brimacombe berry score 

2.     Percentage of first pass successful intubation in each group 

3.     Proportion of failed SGD placement in each group 

4.     Proportion of failed intubation in each group. 

                5.  Complications like sore throat and hoarseness of voice in each group. 

 

     

SCORE 

FIBREOPTIC GLOTTIC VISUALISATION SCORE 

(BRIMACOMBE BERRY SCORE ) 

  1 

No cords seen but function is adequate 

  2 

Vocal cords plus anterior epiglottis seen 

  3 

Vocal cords plus posterior epiglottis seen 

  4 

Only vocal cords seen 

 


 
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