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CTRI Number  CTRI/2021/01/030332 [Registered on: 08/01/2021] Trial Registered Prospectively
Last Modified On: 07/01/2021
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 performance between i-gel and lma blockbuster^TM in adult patients 
Scientific Title of Study   Comparison of clinical performance of I-GEL and LMA BLOCKBUSTERâ„¢ in adult patients during General Anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prerna Prabhat Das 
Designation  Junior resident 
Affiliation  King George Medical University 
Address  Department of Anaesthesia,KGMU.

Lucknow
UTTAR PRADESH
226003
India 
Phone  8910652865  
Fax    
Email  prernaprabhatdas81@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr TANMAY TIWARI 
Designation  MD PDCC MNAMS ASSOCIATE PROFESSOR,dept of Anaesthesia.kgmu. 
Affiliation  KING GEORGE MEDICAL UNIVERSITY 
Address  Dept of Anaesthesia.King George Medical University.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452526270  
Fax    
Email  tanmayanesthesia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr TANMAY TIWARI 
Designation  MD PDCC MNAMS ASSOCIATE PROFESSOR,Dept of Anesthesia,KGMU 
Affiliation  KING GEORGE MEDICAL UNIVERSITY 
Address  Dept of Anaesthesia.KING GEORGE MEDICAL UNIVERSITY.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452526270  
Fax    
Email  tanmayanesthesia@gmail.com  
 
Source of Monetary or Material Support  
Dr.prerna prabhat das.Dept of Anesthesia,King George Medical University.Lucknow. 
 
Primary Sponsor  
Name  Dr prerna prabhat das 
Address  Dept of Anesthesia,KGMU 
Type of Sponsor  Other [Self] 
 
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 prerna das  KING GEORGE MEDICAL UNIVERSITY  Department of Anesthesia,room no.01.
Lucknow
UTTAR PRADESH 		 8910652865

prernaprabhatdas81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,KGMU   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  I-gel and LMA BLOCKBUSTER  The I-gel is innovative 2nd generation supraglottic device. The development of I-gel has changed the face of airway management and is now widely used in anesthesia and resuscitation. Made from a medical grade thermo elastomer, I-gel has been designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and peri-laryngeal structures while avoiding compression trauma. The supraglottic airway device Blockbusterâ„¢ (Tuo Ren Medical Instrument Co., Ltd., Changyuan City, China) is a second-generation supraglottic airway device. Device is a pharyngeally inserted airway device with an anatomically shaped airway tube. It is designed to provide high airway seal pressures around the laryngeal opening and has a separate tract to insert a stomach tube to prevent gastric aspiration.As far as study duration is concerned,it is designated as 1 year for the whole study.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA physiological state 1 and 2
2.undergoing procedure in supine position 
 
ExclusionCriteria 
Details  patient with cardic diseases,lung disorder,uncontrolled diabetes,uncontrolled hypertension,emergency surgery,unanticipated difficult airway 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Time for succesful insertion(visible ETCO2 graph on monitor and acceptable pressure and leak)  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
oropharyngeal leak pressure,ease and required attempts of supraglottic device placement
required attempts of gastric tube placement
quality of airway with controlled ventilation during maintenance of anaesthesia
complication 		 1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/01/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prernaprabhatdas81@gmail.com].

  6. For how long will this data be available start date provided 12-01-2021 and end date provided 01-12-2021?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   TO STUDY THE COMPARISON OF CLINICAL PERFORMANCE OF AIRWAY MANAGEMENT WITH LMA BLOCKBUSTER^TM AND I-GEL IN ADULT PATIENT
The primary objective being time of succesful insertion, and secondary including oropharyngeal leak pressure,sore throat,ease of placement of supraglottic device,and required attempt of gastric tube placement.the study will be conducted in king george medical university,after getting approval from institutional ethical committee.
 
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