| CTRI Number |
CTRI/2017/06/008948 [Registered on: 30/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/06/2019 |
| 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
|
Comparison Of Two New Airway Devices For Planned surgeries Under General Anaesthesia |
|
Scientific Title of Study
|
Comparison of new supraglottic airway device - Baska mask, with I-gel for airway management in general anaesthesia for planned surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gowtham Krishna Jayakumar |
| Designation |
Junior Resident |
| Affiliation |
SSG Medical College and Hospital |
| Address |
Room no:48 New PG 2
Kothi Char rastha
opposit khuber bhavan
Room no:48 New PG 2
Kothi Char rastha
opposit khuber bhavan
Vadodara
GUJARAT
390001
India |
| Phone |
8980808729 |
| Fax |
|
| Email |
gkrisborn2rule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gowtham Krishna Jayakumar |
| Designation |
Junior Resident |
| Affiliation |
SSG Medical College and Hospital |
| Address |
Room no:48
New pg 2
Kothi Char Rastha
Opposite Khuber Bhavan
Vadodara
Room no:48
New pg 2
Kothi Char Rastha
Opposite Khuber Bhavan
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8980808729 |
| Fax |
|
| Email |
gkrisborn2rule@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nimisha Brahmbhatt |
| Designation |
Associate Professor |
| Affiliation |
SSG Medical College and Hospital |
| Address |
B/2,Saikrupa society-2,near Sangam cross road,Harni road,Vadodara-390006
B/2,Saikrupa society-2,near Sangam cross road,Harni road,Vadodara-390006
Vadodara
GUJARAT
390001
India |
| Phone |
9428764477 |
| Fax |
|
| Email |
nimishabrahmbhatt7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gowtham Krishna
Room no:48
New pg 2
Kothi Char Rastha
Opposite Khuber Bhavan
Vadodara |
|
|
Primary Sponsor
|
| Name |
GOWTHAM KRISHNA |
| Address |
Room no:48 New PG 2
Kothi Char rastha
opposite khuber bhavan vadodara 390001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| GOWTHAM KRISHNA |
SSG Medical College and Hospital |
New surgical Block,2 nd floor, Department of Anaesthesia,Jail road, Opp. Bharat Petrol Pump, Indira Avenue, Vadodara, Gujarat 390001
Vadodara
GUJARAT |
8980808729
gkrisborn2rule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients posted for planned surgeries under general anaesthesia with American society of Anesthesiologists grading 1&2, (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baska Mask |
Third generation airway device
in short duration surgeries(2 hrs) |
| Comparator Agent |
I-GEL |
Second generation airway device in short duration surgeries(2 hrs) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgical interventions(i.e General surgeries, Plastic surgeries,Urosurgeries, Gynecological surgeries,Non Head and neck surgeries) of ≤ 2 hours duration under general anaesthesia
Age:18-60 yrs of either sex
Weight: 30-70kg
Mallampati grade I & II
ASA I & II
|
|
| ExclusionCriteria |
| Details |
Patient not willing for participation
Mallampati grade III and IV(Predicted difficult airway)
Mouth opening <2.5cm
ASA III , IV & V
Surgeries in non supine position
Morbidly obese (BMI ≥ 40)
Pregnant patient
Upper respiratory tract infection
Known case of gastroesophageal reflux disease
Oropharyngeal pathology
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 |
| COMPARISON OF BASKA MASK AND I-GEL IN TERMS OF AIRWAY SEALING PRESSURE IN (mm Hg) |
sealing presssure will be measured at 5 minutes post establishment of airway |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Insertion time
Effective airway time
Ease of insertion of the airway device
Number of attempts taken for Baska/i-Gel insertion:
|
insertion time and effective airway time |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2017 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Al-Rawahi, S. A. S., Aziz, H., Malik, A. M., Khan, R. M., & Kaul, N. (2013). A comparative analysis of the Baska mask vs Proseal laryngeal mask for general anesthesia with IPPV. Anaesth Pain & Intensive Care, 17(3), 233-236.
Singh, I., Gupta, M., & Tandon, M. (2009). Comparison of clinical performance of i-gelTM with LMA-ProsealTM in elective surgeries. Indian journal of anaesthesia, 53(3), 302. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose is to evaluate the effectiveness of the Baska mask in comparison with the I-Gel by measuring airway seal pressure.
Study Hypothesis The BASKA Mask will be expected to have better airway sealing pressure compared to I-GEL The I-GEL will be expected to be easier to insert compared to the BASKA mask |