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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [malavikarajasekaran97@gmail.com].

  6. 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.

  7. 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.

 


 
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