| CTRI Number |
CTRI/2022/06/043483 [Registered on: 24/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/06/2022 |
| 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 SEALING PRESSURE of the LARYNGEAL MASK AIRWAY with BASKA MASK in adult patients undergoing elective surgeries under general anaesthesia with intermittent positive pressure ventilation
|
|
Scientific Title of Study
|
"Comparison of the LARYNGEAL MASK AIRWAY with BASKA MASK for general anaesthesia with IPPV" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTSHNAMAYEE MISHRA |
| Designation |
M D Anaesthesiology Resident |
| Affiliation |
B.J. MEDICAL COLLEGE, AHEMEDABAD |
| Address |
F3 DEPARTMENT OF ANAESTHESIA BJMC CIVIL HOSPITAL ASARWA AHMEDABAD GUJARAT INDIA
Ahmadabad
GUJARAT
380016
India |
| Phone |
9668274636 |
| Fax |
|
| Email |
jyotshnamayeemishra55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHAVANA RAVAL |
| Designation |
ASSOCIATE PROFESSOR ,DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
B.J. MEDICAL COLLEGE, AHEMEDABAD |
| Address |
F3 DEPARTMENT OF ANAESTHESIA BJMC CIVIL HOSPITAL ASARWA AHMEDABAD GUJARAT INDIA
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVANA RAVAL |
| Designation |
ASSOCIATE PROFESSOR ,DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
B.J. MEDICAL COLLEGE, AHEMEDABAD |
| Address |
F3 DEPARTMENT OF ANAESTHESIA BJMC CIVIL HOSPITAL ASARWA AHMEDABAD GUJARAT INDIA
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
|
Source of Monetary or Material Support
|
| F3 DEPARTMENT OF ANAESTHESIA BJMC CIVIL HOSPITAL ASARWA AHMEDABAD GUJARAT INDIA AND DR JYOTSHNAMAYEE MISHRA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SUPPLY AND DRJYOTSHNAMAYEE MISHRA |
| Address |
F3 DEPARTMENT OF ANAESTHESIA BJMC CIVIL HOSPITAL ASARWA AHMEDABAD GUJARAT INDIA |
| 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 |
| Jyotshnamayee Mishra |
BJMC CIVIL HOSPITAL AHMEDABAD |
F3 DEPARTMENT OF ANAESTHESIOLOGY AHMEDABAD GUJARAT
Ahmadabad
GUJARAT |
09668274636
jyotshnamayeemishra55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B J Medical College Civil Hospital Ahmedabad |
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 |
| Comparator Agent |
BASKA MASK inserted for general anaesthesia with IPPV |
BASKA MASK inserted according to weight of patient ,ease of insertion and no of attempts , sealing pressure noted , haemodynamic parameters monitered, post of sore throat for 12 hrs and blood stain on BASKA MASK after extubation noted. |
| Intervention |
Classic LMA inserted for general anaesthesia with IPPV |
Classic LMA inserted according to weight of patient ,ease of insertion and no of attempts , sealing pressure noted , haemodynamic parameters monitered, post of sore throat for 12 hrs and blood stain on LMA after extubation noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2
Elective surgeries under general anaesthesia less than 2 hrs duration
modified mallampati grade 1 or 2
supine position
patients who have given consent for procedure |
|
| ExclusionCriteria |
| Details |
Refusal of patient
patients of any pathology of neck , upper respiratory tract or upper alimentary tract
ASA 3 and 4
sore throat
risk of aspiration
patient with mouth opening <2.5 cm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laryngopharyngeal morbidity score |
post operative period upto 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| insertion time |
10 seconds |
| ease of insertion and number of manipulations |
no of attempts during intubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/06/2022 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
THIS TRIAL IS COMPARISON OF THE LARYNGEAL MASK AIRWAY WITH BASKA MASK FOR GENERAL ANAESTHESIA WITH IPPV. IT WILL BE COMPUTER GENERATED RANDOMIZATION SINGLE BLINDING DONE. THE HYPOTHESIS IN OUR STUDY IS THAT THE BASKA MASK , A RECENTLY INTRODUCED AIRWAY DEVICE HAS A HIGHER FIRST TIME INSERTION SUCESS RATE, REQUIRES LESSER TIME OF INSERTION , HAS A HIGHER SEALING PRESSURE , AND LESSER AIRWAY COMPLICATIOS AS COMPARED TO LMA. |