| CTRI Number |
CTRI/2023/11/059475 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Between Two Supraglottic Airway Devices |
|
Scientific Title of Study
|
Comparison Between Baska mask and I-gel for short duration surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malavika Rajasekaran |
| Designation |
DNB Resident |
| Affiliation |
NH MMI Narayana Superspeciality Hospital |
| Address |
Department of Anaesthesiology,
second floor, ot complex, NH-MMI hospital,
Dhamtari Road, Pachpedi Naka Road, Lalpur, Raipur, Chhattisgarh.
Raipur CHHATTISGARH 492001 India |
| Phone |
9047595950 |
| Fax |
|
| Email |
malavikarajasekaran97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun Andappan |
| Designation |
Senior Consultant |
| Affiliation |
NH MMI Narayana Superspeciality Hospital |
| Address |
NH-MMI Hospital, Department of Anaesthesiology, Second floor,ot complex,
Dhamtari Road, Pachpedi Naka Road, Lalpur, Raipur, Chhattisgarh.
Raipur CHHATTISGARH 492001 India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arun Andappan |
| Designation |
Senior Consultant |
| Affiliation |
NH MMI Narayana Superspeciality Hospital |
| Address |
NH-MMI Hospital, Department of Anaesthesiology, Second floor,ot complex,
Dhamtari Road, Pachpedi Naka Road, Lalpur, Raipur, Chhattisgarh.
Raipur CHHATTISGARH 492001 India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
|
Source of Monetary or Material Support
|
| NH MMI Narayana Superspeciality Hospital |
|
|
Primary Sponsor
|
| Name |
NH MMI Narayana Superspeciality Hospital |
| Address |
Dhamtari Road, Pachpedi Naka Road, Lalpur, Raipur, Chhatisgarh. |
| 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 |
| Dr Malavika Rajasekaran |
NH MMI Narayana Superspeciality Hospital |
NH-MMI Hospital, Department of Anaesthesiology, Second floor, ot complex,
Dhamtari Road, Pachpedi Naka Road , Lalpur , Raipur, Chhatisgarh-492001 Raipur CHHATTISGARH |
9047595950
malavikarajasekaran97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES,, RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BASKA |
Size 3 and size 4 used for short procedures of duration 120 minutes |
| Comparator Agent |
I-GEL |
Size 3 and size 4 used for short procedures of duration 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I and II patients
2. Mallampati grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
1. Patients with ASA III or above
2. anticipated difficult airway
3. patients with increased aspiration risk
4. BMI >30kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the oropharyngeal leak pressure between the two devices.
2. Insertion time
3. Number of attempts required to insert
|
To measure the oropharyngeal leak pressure between the two devices immediately after insertion and 30 mins after insertion
2. Insertion time
3. Number of attempts required to insert
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess hemodynamical parameters of the patient
2 To analyse intraoperative & post operative airway related complications |
Hemodynamic parameters during the duration of surgery every thirty minutes
Post operative airway complications for 24 hours |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [malavikarajasekaran97@gmail.com].
- For how long will this data be available start date provided 30-12-2025 and end date provided 30-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A
COMPARISON BETWEEN BASKA MASK AND I-GEL
FOR SHORT DURATION SURGERIES
Patients undergoing general
anaesthesia should have a secured airway especially
in long duration surgeries.
However, for shorter surgical procedures, the airway
can be kept patent by the
use of supraglottic airway devices without
administering neuromuscular blockers
thus lesser impact on patient’s
hemodynamic s and lesser
trauma to airway. Also
these devices have
high airway seal pressure
with low resistance to gas
flow , low incidence of
aspiration and complications . These
are divided into
first , second and third generation airway devices.
The newest include Baska
mask and I-GEL
which have a cuffless sealing mechanism
due to its thermoelastic
material which can expand
on heat , also preventing injury
to airway and problems of
maintaining sealing pressure . Both devices have an airway
channel separate from gastric channel to
provide additional safety in
laparoscopic surgeries . They also
have laryngoprotective properties.
I-GEL which is a second generation supraglottic airway
device made from styrene-ethylene- butylene. It has an additional bite block.
It is also comparable to LMAs and proseal LMAs in insertion rates and sealing
pressures.
Baska mask, introduced by Kanag and Meena Baska , a 3rd
generational airway with one gastric channel and a pharyngeal channel with a
bite block. Various studies and journals supporting this thesis work has been
done . Studies have also been perfomed on laparoscopic surgeries , minor
urological and gynaecological
procedures, in obese and spontaneously ventilating patients.
Shamugavelu et al. conducted a study comparing both i-Gel
and Baska mask in laparoscopic surgeries and concluded that both airways are
comparable with each other in larascopic surgeries and i-Gel is quicker to
insert whilst Baska gave a good airway seal.
Our study will compare Insertion time,
Number of attempts required to insert, oropharyngeal leak pressure between the
two devices. We will also assess hemodynamic stability of the patient and
analyse intraoperative and post operative airway related complications.
|