| CTRI Number |
CTRI/2022/12/048510 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
24/12/2022 |
| 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
|
Study to compare two methods of Baska mask insertion for surgeries under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of insertion techniques of Baska mask:Digital versus Pharyngoscopic technique in adult patients under controlled ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKSHAYA AK |
| Designation |
Junior resident |
| Affiliation |
Sapthagiri institute of medical sciences and research centre |
| Address |
Sapthagiri hospital,near navylayout,15,hesargatta main road,chikkasandra,bangalore-560090
Bangalore Rural
KARNATAKA
560090
India |
| Phone |
8903422215 |
| Fax |
|
| Email |
akshayaak24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renuka R |
| Designation |
Professor |
| Affiliation |
Sapthagiri institute of medical sciences and research centre |
| Address |
Sapthagiri hospital,near navylayout,15,hesargatta main road,chikkasandra,bangalore-560090
Bangalore Rural
KARNATAKA
560090
India |
| Phone |
8618633196 |
| Fax |
|
| Email |
drmadhumitha99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKSHAYA AK |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sapthagiri institute of medical sciences and research centre |
| Address |
4th floor OT complex, department of anesthesiology,sapthagiri Institute of Medical sciences and research centre, 15,hesargatta main road,chikkasandra,bangalore-560090
Bangalore Rural
KARNATAKA
560090
India |
| Phone |
8903422215 |
| Fax |
|
| Email |
akshayaak24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri institute of medical sciences and research centre |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical sciences and research centre |
| Address |
Navy layout,15,hesargatta main road, chikkasandra, Bangalore -560090 |
| 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 |
| Akshaya AK |
Sapthagiri Institute of Medical sciences and research centre |
4th floor OT complex, department of anesthesiology,sapthagiri hospital, Near navy layout, 15,hesargatta main road, chikkasandra.
Bangalore Rural
KARNATAKA |
8903422215
akshayaak24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical sciences and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (3) ICD-10 Condition: K35-K38||Diseases of appendix, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Digital technique |
Baska mask will be inserted using the index finger and advanced along the palatopharyngeal curve into the hypopharynx until the resistance will be felt.The duration from induction till confirmation of placement of the device is approximately 5 minutes |
| Intervention |
Pharyngoscopic technique |
Baska mask will be held like a pen and will be inserted into the pharynx after pharyngoscopy (pushing the tongue to the left side of the mouth) using a laryngoscope.The duration from induction till confirmation of placement of the device is approximately 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2,posted for short surgical procedures (<2 hours) under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in the study
Patients with anticipated difficult airway with mouth opening <2.5cm
Patients those at risk of aspiration (non fasted, gastroesophageal reflux disease, pregnancy)
Patient with history of recent sore throat |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate of insertion at first attempt in both techniques |
From the time of picking the baska mask and successful placement at first attempt,which is monitored and recorded as baseline value |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time taken for successful insertion and ease of insertion
|
Time from picking the baska mask to its successful placement and hemodynamic variables monitored for first 15 minutes |
| To compare the post operative complications in both the groups |
From the time of extubation to 1 hour postoperative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/12/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Baska mask is a third generation airway device with many advantages over endotracheal tube and other airway devices. Insertion of baska mask was considered difficult comparing with other supraglottic airway devices.Hence this study was formulated to compare the two different techniques of insertion. The results of this study will guide for better insertion technique of baska mask for successful placement. |