FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034932 [Registered on: 16/07/2021] Trial Registered Prospectively
Last Modified On: 20/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the ease of putting a tube inside the trachea for breathing of paralyzed patient between Blockbuster tube a type of ET tube versus microcuff tube a type of ET tube while putting through blockbuster LMA,an airway used here for inserting the breathing tube in children undergoing surgery 
Scientific Title of Study   Comparison of ease of intubation of Blockbuster Endotracheal tube versus Microcuff Endotracheal Tube using Blockbuster Laryngeal mask airway in young children undergoing elective surgery: A Randomized interventional study , SMS Medical college and Attached group of hospitals, Jaipur 2020-21 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Dogra 
Designation  Senior Professor 
Affiliation  SMS Medical College, Jaipur 
Address  Department Of Anaesthesiology, Jk Loan Hospital OT, 1st floor, Jk Loan Hospital, SMS medical college, Jaipur
Department of Anaesthesiology, second floor, Dhanwantari Building, SMS Medical College,Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neelam Dogra 
Designation  Senior Professor 
Affiliation  SMS Medical College, Jaipur 
Address  Department Of Anaesthesiology, Jk Loan Hospital OT, 1st floor, Jk Loan Hospital, SMS medical college, Jaipur
Department of Anaesthesiology, second floor, Dhanwantari Building, SMS Medical College,Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sabarish D 
Designation  Resident Doctor 
Affiliation  SMS Medical College 
Address  Department of Anaesthesiology, second floor, Dhanwantari Building, SMS Medical College,Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9952820924  
Fax    
Email  sabarish93@gmail.com  
 
Source of Monetary or Material Support  
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL 
 
Primary Sponsor  
Name  Department of anaesthesiology SMS Medical College 
Address  JLN Marg, Jaipur  
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 
Sabarish  Department of anaesthesiology, JK Loan hospital  First floor, Jk Loan hospital OT,JK Loan Hospital(S.P.M.C.H.I), JLN Marg, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN 
9952820924

sabarish93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS MEDICAL COLLEGE AND ATTACHED 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 
Intervention  Blockbuster Endotracheal Tube  Patient will be intubated with Blockbuster Endotracheal Tube of appropriate size for age till the end of procedure  
Comparator Agent  Microcuff Endotracheal Tube  Patient will be intubated with Microcuff Endotracheal Tube appropriate size for age till the end of procedure  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  ASA Grade 1 and 2
Children of both sexes
Elective surgeries under general anaesthesia requiring endotracheal intubation
children of weight 10-20kg whom Blockbuster LMA 2 can be used

 
 
ExclusionCriteria 
Details  Children with congenital anomalies, hypertrophied tonsils, neck swelling, respiratory tract pathology and previous upper gastro intestinal surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean duration of time taken for successful intubation  immediately after successful intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Mean Number of attempts for successful intubation  immediately after successful intubation 
percentage of failed intubation  immediately after unsuccessful intubation 
To determine the mean cuff sealing pressure between two groups  immediately after successful intubation using hand held cuff inflator 
percentage of cases with any side effects  At the end of surgery post extubation 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2021 
Date of Study Completion (India) 20/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is randomized interventional study comparing the ease of intubation of Blockbuster ET Tube versus Microcuff ET Tube using Blockbuster LMA  in young children aged between 1 year to 5 years by measuring the mean time duration of intubation, number of attempts for successful intubation and percentage of failed intubation in 72 children (36 in each group) as the primary outcome. As the secondary outcome mean tracheal seal pressure will be measured in two groups and percentage of side effects like sore throat, laryngospasm and cough after extubation. The will be conducted in Department of Anaesthesiology, JK Loan hospital, sms medical college and hospital, Jaipur 
Close