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CTRI Number  CTRI/2018/02/011947 [Registered on: 19/02/2018] Trial Registered Prospectively
Last Modified On: 11/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A research to evaluate and compare two medical devices (Blockbuster and Fastrach Laryngeal Mask Airway), used to ventilate patients undergoing surgery.  
Scientific Title of Study   Comparative evaluation of BlockBuster and Fastrach Laryngeal Mask Airway for endotracheal intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Kumaar 
Designation  Post Graduate Junior Resident 
Affiliation  Government medical college and hospital, chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160031
India 
Phone  9944357333  
Fax    
Email  arundec06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lakesh K Anand 
Designation  Professor 
Affiliation  Government medical college and hospital, chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160031
India 
Phone  9646121522  
Fax    
Email  lkanand11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arun Kumaar 
Designation  Post Graduate Junior Resident 
Affiliation  Government medical college and hospital, chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160031
India 
Phone  9944357333  
Fax    
Email  arundec06@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, sector 32, Chandigarh 
 
Primary Sponsor  
Name  Government medical college 
Address  Government Medical College and Hospital, sector 32, Chandigarh 
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 Arun Kumaar  Operation theatre  Operation theatre, Block C,level 2,3 Government medical college and hospital, sector 32, chandigarh
Chandigarh
CHANDIGARH 
9944357333

arundec06@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  All participants will be either ASA ( American Society of Anaesthesiologists) grade 1 or 2.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blockbuster Laryngeal Mask Airway  Will be used to maintain the patency of airway during general anaesthesia. The device will be inserted only after the induction of anaesthesia. 
Comparator Agent  Fastrach Laryngeal Mask Airway  Will be used to maintain the patency of airway during general anaesthesia. The device will be inserted only after the induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The following patients would be included for the study
1. Age group of 18 to 60 years
2. American Society of Anesthesiologists (ASA) status I and II
3. Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation.  
 
ExclusionCriteria 
Details  The following patients would be included for the study
1. Morbid obesity BMI > 35 kg/m2
2. Patients with anticipated difficult airway (Airway Difficulty Score>8)
3. Patients at increased risk of aspiration like gastroesophageal reflux, peptic ulcer
4. Previous upper gastrointestinal surgery
5. Coagulopathy or history of anticoagulant use 6. Cardiorespiratory or cerebrovascular disease 7. Cervical spine injury
8. Pregnant patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the success rate of tracheal intubation with BlockBuster and Fastrach Laryngeal Mask Airway.  immediately after the placement of the device 
 
Secondary Outcome  
Outcome  TimePoints 
To compare insertion success rates of two Laryngeal Mask Airway’s, oropharyngeal leak pressure, fiberoptic visualization of glottis, hemodynamic parameters and post-operative complication if any.
 
1. Ease of insertion of device, ease of use of gastric tube placement and fiberoptic visualization- will be observed immediately after the placement of the device.
2. Hemodynamic and ventilatory parameters- every minute till 15 min after the placement of device. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) 28/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The present study entitled “Comparative evaluation of BlockBuster and Fastrach Laryngeal Mask Airway for endotracheal intubation.”, was a prospective, randomised and controlled study done to evaluate and compare the performance of Blockbuster and LMA Fastrach for tracheal intubation in 100 adult patients of ASA physical status 1/2 of either sex, in the age group of 18-60 years undergoing elective surgeries under general anaesthesia. After approval of protocol by Hospital Ethics Committee, Clinical Trial Registry-India (CTRI/2018/02/011947); and written informed consent, patients were randomly allocated into following groups of 50 each:

Group 1 (Blockbuster) (n=50) in which Blockbuster was used

Group 2 (FT-LMA) (n=50) in which LMA Fastrach was used

A standard monitoring and anaesthetic technique was used for all the patients. All patients were pre-medicated with inj. Glycopyrrolate 0.2 mg, inj. Midazolam 0.04 mg/kg intravenously, 5 min before induction. After pre-oxygenation for three minutes, anaesthesia was induced using morphine 0.1 mg/kg, propofol 2.0 to 2.5 mg/kg. After checking for ability to achieve adequate mask ventilation, vecuronium 0.1 mg/kg was used to facilitate muscle relaxation. After opening the sealed envelope, the allocated Blockbuster or FT-LMA was inserted. The cuff was inflated with intracuff pressure of 60 cm H2O; optimal positioning and ventilation were observed without an audible leak. The oropharyngeal leak pressure and fibreoptic view of the larynx were determined. A well lubricated cuffed ETT of appropriate size was inserted blindly to accomplish intubation. If resistance was felt during blind attempt, the FOB guided intubation was performed. At confirmation of correct placement of the tracheal tube, SAD was removed using stabilizing rod to keep tracheal tube in place.

The SAD insertion parameters including number of attempts, ease of insertion; time taken for Blockbuster or FT-LMA insertion; OLP; fibreoptic grading of laryngeal view; number of attempt and time taken for tracheal intubation; time taken for SAD removal and blood stained on SAD were noted. Hemodynamic parameters were obtained at the following time points: baseline; after induction of anaesthesia; after device insertion, after 1 min, 2 min, 3 min, 4 min, 5 min and 10 min of tracheal intubation after SAD removal. Postoperative sore throat, hoarseness of voice, dysphagia in the first post-operative hour was recorded. The observations were analysed using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, version 22.0 for Windows) and the following conclusions were drawn:

1.       Both the groups were comparable in relation to the demographic profile of the patients (age, gender, ASA grade, weight, height, Body mass index).

2.       The number of attempts, time taken and ease of insertion of Blockbuster and FT-LMA was similar in both the groups.

3.       Mean OLP 28.30±1.89 cm H2O versus 24.46±1.75 cm H2O in Blockbuster and FT-LMA group respectively.

4.       Fibreoptic view of the vocal cords (grades 4: only vocal cord seen and 3: vocal cord score plus posterior epiglottis visible) was comparable in both the groups.

5.       The success of first attempt blind endotracheal intubation was significantly higher in the Blockbuster (100%) group than the FT-LMA (94%) group.

6.       No patients in Blockbuster group while 3 (6%) patients in FT-LMA group required second attempt using FOB.

7.       Time taken for endotracheal intubation was lesser with Blockbuster group (14.14±2.49 sec) as compared with FT-LMA group (18.34±2.86 sec)

8.       The hemodynamic parameters (HR, SBP, DBP and MAP) at different point of time were comparable in both the groups. Hemodynamic parameters increased after one min of intubation in both the groups with lesser increase in group 1(statistically significant)

9.       The presence of macroscopic blood stain was comparable in both groups.

10.    The incidence and degree of sore throat was comparable in both the groups. 
 
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