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
|
|
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
|
|
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 |