| CTRI Number |
CTRI/2018/02/011748 [Registered on: 07/02/2018] Trial Registered Prospectively |
| Last Modified On: |
04/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial comparing 2 laryngeal mask airways(type of devices used for airway management) - Baska Mask and I-gel in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of Baska Mask with I-gel in patients undergoing elective surgery under general anaesthesia : A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilma Shaju |
| Designation |
PGJR |
| Affiliation |
Government medical college hospital, Chandigarh |
| Address |
Department of anaesthesia and intensive care, Government Medical College Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9003282020 |
| Fax |
|
| Email |
shilmaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manpreet Singh |
| Designation |
Associate Professor |
| Affiliation |
Government medical college hospital, Chandigarh |
| Address |
Department of anaesthesia and intensive care, Government Medical College Hospital,Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manpreet Singh |
| Designation |
Associate Professor |
| Affiliation |
Government medical college hospital, Chandigarh |
| Address |
Department of anaesthesia and intensive care, Government Medical College Hospital,Sector 32, Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director Principal, Government Medical College Hospital, Sector 32, Chandigarh, Pincode - 160030 |
|
|
Primary Sponsor
|
| Name |
Director Principal |
| Address |
Government medical college hospital, sector 32, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shilma Shaju |
Government medical college hospital,Sector 32, Chandigarh |
Department of Anaesthesia and Intensive Care, Government Medical College Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9003282020
shilmaz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective surgery general anaesthesia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baska Mask |
2nd generation supraglottic airway device |
| Comparator Agent |
I-gel |
2nd generation supraglottic airway device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist (ASA) physical status I and II
Patients scheduled for elective surgery under general anaesthesia ( duration of surgery 2+/-0.5hrs) |
|
| ExclusionCriteria |
| Details |
Patients with : 1)anticipated difficult airway (ADS>8)
2)upper respiratory tract infection 3)increased risk of regurgitation and aspiration of gastric content 4)BMI >35kg/m2 5)history of radiotherapy to neck involving the hypopharynx 6)undergoing surgeries involving neck and oral cavity 7)pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure |
0-5 minutes after device insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of insertion,fibre optic visualisation of glottis, hemodynamic and ventilation parameters,postoperative complications |
At 0,5,10,15 minutes of device insertion |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
19/02/2018 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, single blinded, active controlled trial, comparing Baska Mask and I-gel supraglottic airway devices in patients undergoing elective surgery under general anaesthesia in Government Medical College Hospital, Chandigarh, India. The primary outcome is Oropharyngeal Leak Pressure. The secondary outcomes are ease of insertion, fibreoptic visualisation of glottis, hemodynamic and ventilation parameters and postoperative complications. |