| CTRI Number |
CTRI/2018/02/011965 [Registered on: 19/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Compare the safety of newer supra glottic device baska mask with i-gel |
|
Scientific Title of Study
|
Comparison of Baska® Mask versus I-gel for minor surgical procedures under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopa Sachidananda |
| Designation |
Assistant professor |
| Affiliation |
KIMS Hubli |
| Address |
Dept of Anaesthesia
KIMS
HUBLI
KIMS Hubli Karnataka India 580021
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Safiya I Shaikh |
| Designation |
Professor and HOD |
| Affiliation |
KIMS Hubli |
| Address |
Dept of Anaesthesia
KIMS Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9448861706 |
| Fax |
|
| Email |
ssafiya11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Roopa Sachidananda |
| Designation |
Assistant professor |
| Affiliation |
KIMS Hubli |
| Address |
Dept of Anaesthesia
KIMS
Hubli
Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KIMS |
| Address |
KIMS
Hubli
Karnataka
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KIMS |
Hubli Karnataka
India |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Roopa Sachidananda |
Karnataka Institute of Medical Sciences |
Department of Anaesthesia
Dharwad
KARNATAKA |
9448658220
roopasac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baska Mask |
Supraglottic airway device |
| Comparator Agent |
I gel |
Supraglottic airway device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists’physical status I and II who underwent minor surgical procedures ( duration < 60 minutes) under general anaesthesia. Patients who underwent elective surgical procedures with fasting period of 6 hours and Mallampati I,II or III. |
|
| ExclusionCriteria |
| Details |
Patients with neck pathology, anticipated difficult airway, pregnant women, increased risk of aspiration, mouth opening <2.5 cm, body mass index >30 kg.m-2 |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First time success rate % |
successful placement of the device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of insertion of the device
Sealing pressure
Ease of insertion of gastric tube |
After successful placement of the device |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2017 |
| Date of Study Completion (India) |
31/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Abstract
Background
Minor surgical
procedures under general anaesthesia requires a patent airway without the use
of muscle relaxant. supraglottic airway devices have been used widely for
airway management. A study was undertaken to compare first time insertion
success rate, insertion time, sealing pressure and complications of Baska®
Mask with I-gel.
Methods
After approval from the
institutional ethical committee ,a randomized
single blinded study was conducted on 50 American Society of
Anesthesiologists’physical status I and II female patients aged between 18-40
years who underwent minor surgical procedures
( duration < 60 minutes) under general anaesthesia. Patients were randomized into two groups of
25 each, by sealed envelope technique. (group B-Baska® Mask ; group
I-I-gel). All patients were monitored
using non-invasive blood pressure (NIBP), electrocardiogram (ECG), pulse
oximetry and capnography. The first time success rate, mean insertion time and
sealing pressure were measured.
Results
The first time success
rate of Baska® Mask was 21/24
(88%) when compared to I-gel which was 23/25 (92%) p 0.585. The insertion time of Baska®
Mask was 14.9±6.2 s and that of I-gel
was 14.7±4.4 s. (p 0.877) The mean
sealing pressure of Baska® Mask
was significantly higher when compared to the I-gel (28.9±3.5 vs 25.9±2.5 cm H2O) p 0.001
Baska® Mask
has a first time success rate, insertion time which is comparable with I-gel.
The sealing pressure of Baska®
Mask was significantly more than I-gel.
Both the devices had complications which were comparable.
|