| CTRI Number |
CTRI/2024/03/063711 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the two advanced airway devices for airway management |
|
Scientific Title of Study
|
Comparison of Blockbuster laryngeal mask airway versus Ambu Aura Gain supraglottic airway devices as a conduit for blind endotracheal intubation: A Randomized Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivanshu Gupta |
| Designation |
junior resident |
| Affiliation |
Teerthanker mahaveer medical college and research center , moradabad, uttar pradesh |
| Address |
Room no 204,2nd FLOOR Teerthanker mahaveer medical college and research centre Moradabad
Room no 204,2nd FLOOR Teerthanker mahaveer medical college and research centre Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8958880908 |
| Fax |
|
| Email |
Shivanshgupta.mbd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and research center, Moradabad, Uttar pradesh |
| Address |
Room no 204,2nd FLOOR Teerthanker Mahaveer Medical College and Research centre Moradabad Department of Anaesthesiology
Room no 204,2nd FLOOR Teerthanker Mahaveer Medical College and Research centre Moradabad Department of Anaesthesiology
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218628850 |
| Fax |
|
| Email |
drpallaviahluwalia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Shahbaz alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and research center, Moradabad, Uttar pradesh |
| Address |
Room no 204,2nd FLOOR Teerthanker Mahaveer Medical College and Research Centre Moradabad Department of Anaesthesiology
Room no 204,2nd FLOOR Teerthanker Mahaveer Medical College and Research Centre Moradabad Department of Anaesthesiology
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College, Moradabad,Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Center Moradabad Uttar Pradesh |
| Address |
Teerthanker Mahaveer Medical College and Research Center Moradabad Uttar Pradesh |
| Type of Sponsor |
Private 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 |
| Dr Shivanshu Gupta |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
Teerthanker Mahaveer Medical College and Research Center Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH |
8958880908
Shivanshgupta.mbd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, T.M. UNIVERSITY, MORADABAD, UTTAR PRADESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BLOCKBUSTER LMA AND AMBU AURA GAIN SUPRAGLOTTIC AIRWAY |
To compare the oropharyngeal leak pressure and number of attempts for successful intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of the American Society of Anaesthesiologists physical status I and II,mallampati score 1 and 2,scheduled for general anaesthesia, informed and written consent |
|
| ExclusionCriteria |
| Details |
Adults patients with anticipated difficult airway, BMI more than 30kg/m2,mouth opening less than 2 fingers,mallampati score 3 and 4, limited neck extension |
|
|
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 |
Each participant in the study will be assessed for following primary outcome parameters are as follows:-
1 To note the numbers of attempts for successful intubation in both the groups.
2 To compare oropharyngeal leak pressure in both the groups. |
5 minutes 15 minutes 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Each participant in the study will be assessed for following secondary outcome parameters are as follows:-
1 To measure insertion time in both the groups
2 To compare the ease of LMA insertion
3 To check Cormack-lehane grading before insertion.
4 To compare the haemodynamic parameters in both the groups.
5 To assess and compare any complication in both the groups. |
Will be monitored before insertion of device upto 30 minutes and thereafter every 15 minutes till the completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is planned in context to compare Ambu Auragain and blockbuster LMA in terms of ease of insertion, time taken for insertion, oropharyngeal seal pressure and a conduit for blind endotracheal insertion of both devices in adults patients under general anesthesia. |