| CTRI Number |
CTRI/2020/05/025470 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
14/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE LARYNGEAL MASK AIRWAY BLOCKBUSTER WITH INTUBATING LARYNGEAL MASK AIRWAY FOR INTUBATION |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF LARYNGEAL MASK AIRWAY BLOCKBUSTER VERSUS INTUBATING LARYNGEAL MASK AIRWAY FOR INTUBATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKIT SINHA |
| Designation |
POST-GRADUATE RESIDENT |
| Affiliation |
DEPARTMENT OF ANAESTHESIA,MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIA,THIRD FLOOR,B.L TANEJA BUILDING,MAMC CAMPUS,DELHI-110002
BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002
New Delhi
DELHI
110002
India |
| Phone |
9811329969 |
| Fax |
|
| Email |
ideal.ankitsinha@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KIRTI NATH SAXENA |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
DEPARTMENT OF ANAESTHESIA,MAULANA AZAD MEDI |
| Address |
DEPARTMENT OF ANAESTHESIA, 3RD FLOOR,B.L TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002
BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002
New Delhi
DELHI
110002
India |
| Phone |
9968604215 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KIRTI NATH SAXENA |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
DEPARTMENT OF ANAESTHESIA,MAULANA AZAD MEDI |
| Address |
DEPARTMENT OF ANAESTHESIA, 3RD FLOOR,B.L TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002
BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002
New Delhi
DELHI
110002
India |
| Phone |
9968604215 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE,NEW DELHI |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLLEGE |
| Address |
BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002 |
| 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 |
| ANKIT SINHA |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE |
MAULANA AZAD MEDICAL COLLEGE,NEW DELHI-110002
New Delhi
DELHI |
9811329969
ideal.ankitsinha@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA 1 & 2) patients |
|
| ExclusionCriteria |
| Details |
1. Patients with cardiovascular diseases
2. Risk of aspiration pneumonitis e.g, pregnant patients, history of gastro-oesophageal reflux
3. Obesity (Body Mass Index > 30kg/metre square
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken for successful tracheal intubation by Blockbuster Laryngeal Mask Airway and Intubating Laryngeal Mask Airway
|
Time taken after achieving adequate ventilation by both airway devices to time taken to achieve successful tracheal intubation by both Blockbuster Laryngeal Mask Airway and Intubating Laryngeal Mask Airway.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time taken for successful insertion of airway device
2.Number of attempts for successful insertion
3.Haemodynamic changes following intubation
4. Time taken for removal of ILMA/Blockbuster LMA |
1. Time taken for insertion of device
2. Succesful insertion is from insertion of device to achieving adequate ventilation
3 Haemodynamic changes following intubation at 1,2,3,4,5,10 and 15th minute
4.Time taken to successfully remove the primmer airway device with tracheal tube in-situ |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/06/2020 |
| 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)?
|
|
Brief Summary
|
A newer device similar to ILMA was recently designed in 2012 with the name Blockbuster Laryngeal mask airway by Professor Ming Tian . The efficacy and success of the new airway device have not been studied much and comparison with other devices of the airway management is limited. Due to its ease of use, speed of implantation, and success rate, the aim is to compare Blockbuster LMA and ILMA methods in patients undergoing elective surgery during general anaesthesia to evaluate whether it is an acceptable alternative for airway management. |