| CTRI Number |
CTRI/2019/03/017981 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two devices used to maintain oxygenation in patients undergoing anaesthesia |
|
Scientific Title of Study
|
A RCT COMPARING EFFICACY
& COMPLICATIONS BETWEEN
BASKA MASK AND CLASSIC
LARYNGEAL MASK AIRWAY IN
ANAESTHETIZED
SPONTANEOUSLY
BREATHING PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Gayathri |
| Designation |
PROFESSOR |
| Affiliation |
SRM MCH RC |
| Address |
B 102 Newry Shrenika Jayachandran nagar 1st main road
jalladampet chennai
Room No 211
Department of Anaesthesia
Second floor
SRM MC Hospital
Kattankulathur
Kancheepuram
TAMIL NADU
600100
India |
| Phone |
|
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B Gayathri |
| Designation |
PROFESSOR |
| Affiliation |
SRM MCH RC |
| Address |
B 102 Newry Shrenika Jayachandran nagar 1st main road
jalladampet chennai
Room No 211
Department of Anaesthesia
Second floor
SRM MC Hospital
Kattankulathur
Kancheepuram
TAMIL NADU
600100
India |
| Phone |
|
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Nandhini |
| Designation |
post graduate student |
| Affiliation |
SRM MCH RC |
| Address |
137 Govindammal nagar
Seelanaiken patty
Salem
Room No 211
Department of Anaesthesia
Second floor
SRM MC Hospital
Kattankulathur
Kancheepuram
TAMIL NADU
636201
India |
| Phone |
|
| Fax |
|
| Email |
nandhiniadithi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 211
Department of Anaesthesia
Second floor
SRM MC Hospital
Kattankulathur |
|
|
Primary Sponsor
|
| Name |
SRM MCH RC |
| Address |
Room No 211
Department of Anaesthesia
Second floor
SRM MC Hospital
Kattankulathur |
| 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 |
| B Gayathri |
SRM MCH RC |
Room number 211
Department of Anaesthesiology
second floor
Kancheepuram
TAMIL NADU |
9500092905
gayathrii.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee SRM MCH RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BASKA mask |
BASKA mask is the new generation anaesthetic device used to maintain airway in patients under anaesthesia |
| Comparator Agent |
Classical laryngeal amsk |
classical laryngeal mask is the first generation anaesthetic device used to maintain airway in patients under anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and ASA 2
MPC 1 and 2
Elective minor procedures |
|
| ExclusionCriteria |
| Details |
ASA 3 and ASA 4
Patients with difficult intubation
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Number of attempt taken for insertion of device
2 Time taken to insert the device
3 Measurement of pressure required to elicit leak after inserting the device
4 Ease of intubating with device
|
1 Number of attempt taken for insertion of device
2 Time taken to insert the device
3 Measurement of pressure required to elicit leak after inserting the device
4 Ease of intubating with device
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Changes in pulse rate
2 Changes in blood pressure |
1 From the time of insertion of device to next 10 minutes till airway response ends
2 From the time of insertion of device to next 10 minutes till airway response ends |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/04/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Maintenance of airway is of extreme importance in patients undergoing anesthesia for surgical procedures. From time to time there has been multiple gadgets used to maintain oxygenation. Laryngeal mask airways have come a long way as easy to use, handy instrument for airway maintenance.
The problem with LMA is aspiration. BASKA mask is 3rd generation LMA which claims that the seal produced in pharynx is better and there is no chance of aspiration. In addition there is a sump in the gadget which drains the fluid collected in the oesophagus by active suction There are hardly any studies where BASKA msk has been compared
|