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CTRI Number  CTRI/2025/06/089896 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 15/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of BASKA Mask and Igel Supraglottic Airway devices in Patients undergoing Planned Surgery 
Scientific Title of Study   Comparison of BASKA Mask and Igel Supraglottic Airway devices in Patients undergoing Elective Surgery - Randomized Control Trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srinivasan S K 
Designation  Professor 
Affiliation  Vinayaka Missions Medical College and Hospital, Karaikal 
Address  Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal PONDICHERRY 609609 India

Karaikal
PONDICHERRY
609609
India 
Phone  9360363321  
Fax    
Email  drsrisha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pallaki Sai Mishita Reddy 
Designation  Junior Resident/Post Graduate 
Affiliation  Vinayaka Missions Medical College and Hospital, Karaikal 
Address  Room No 2 Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal PONDICHERRY 609609 India

Karaikal
PONDICHERRY
609609
India 
Phone  9108102566  
Fax    
Email  mishitapallaki42@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pallaki Sai Mishita Reddy 
Designation  Junior Resident/Post Graduate 
Affiliation  Vinayaka Missions Medical College and Hospital, Karaikal 
Address  Room No 2 Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal PONDICHERRY 609609 India

Karaikal
PONDICHERRY
609609
India 
Phone  9108102566  
Fax    
Email  mishitapallaki42@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Medical College and Hospital, Keezhakasudimedu,Karaikal, Pondicherry,India-609609 
 
Primary Sponsor  
Name  Vinayaka Missions Medical College and Hospital  
Address  Vinayaka Missions Medical College and Hospital Keezhakasakudy Medu Kottucherry post Puducherry 609609 
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 Pallaki Sai Mishita Reddy  Vinayaka Missions Medical College and Hospital  Room No.2, Department of Anaesthesiology
Karaikal
PONDICHERRY 
9108102566

mishitapallaki42@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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 MASK  Participants will undergo insertion of BASKA Mask during elective procedures. 
Intervention  I-GEL  Participants will undergo insertion of I-GEL during elective procedures. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - ASA Class I,II and III
- BMI less than 35kg/m2
- Surgery for less than 1 hour
- Patients who provide informed consent for participation in the study
 
 
ExclusionCriteria 
Details  - Pregnancy
- Undergoing head and neck surgeries
- Previous history of difficult intubation
- Risk of gastric aspiration
- Mouth opening less than 3 cm.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) To assess and compare the overall success rate of airway management, including successful insertion and ventilation efficacy by using the Baska mask and I-gel in patients undergoing elective surgery.

2) To compare the ease of use and handling by healthcare providers for the Baska mask and I-gel. 
until end of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the incidence of complications (e.g., airway leaks, desaturation events) associated with the use of the Baska mask and I-gel.

2. To investigate the impact of patient characteristics (e.g., age, BMI) on the performance of the Baska mask and I-gel in elective surgery scenarios. 
until end of procedure 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/06/2025 
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)   Not Applicable 
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 - NO
Brief Summary  
  1. INTRODUCTION:

       Surgical procedures under general anaesthesia require a patent airway for safe and smooth conduction of anaesthesia . For such procedures, various supraglottic airway devices have been designed and are being used exceedingly. Although endotracheal intubation is the gold standard for airway management, it is being replaced by supraglottic airway devices because they are easy to introduce, better tolerated and results in a lesser haemodynamic response. Further these devices have lesser implications on airway and respiratory mechanics.

2. RESEARCH QUESTION: IS BASKA MASK BETTER THAN I GEL IN ELECTIVE SURGERIES ?

3.AIM AND OBJECTIVES:

Aim:

Compare the effectiveness of  I-gel and Baska mask in terms of Ease of Insertion and its success rate, sealing pressure, Quality of ventilation and incidence of post insertion complications.

Primary Objective:

1)    To assess and compare the overall success rate of airway management, including successful insertion and ventilation efficacy by using the Baska mask and I-gel in patients undergoing elective surgery.

2)    To compare the ease of use and handling by healthcare providers for the Baska mask and I-gel.

Secondary Objectives:

1. To evaluate the incidence of complications (e.g., airway leaks, desaturation events) associated with the use of the Baska mask and I-gel.

2. To investigate the impact of patient characteristics (e.g., age, BMI) on the performance of the Baska mask and I-gel in elective surgery scenarios.

 

5.REVIEW OF LITERATURE:

 

1)   According to a study by Sinasamy et Al, Group IG showed a significantly shorter median insertion time (13.3 [interquartile range, IQR 7.8] vs. 17.0 [IQR 9.6] s; P < 0.001), a higher percentage in the ’very easy’ ease of insertion category (62.5% vs. 10.0%; P < 0.001), a higher percentage in the no corrective manoeuvre category (92.5% vs. 72.5%; P = 0.003) and a higher percentage in the no post-operative throat pain category (67.5% vs. 32.5%; P = 0.011) than Group BM. However, Group BM showed a significantly higher generated PAP than Group IG (12.7 [1.8] and 11.5 [2.2] cm H2O, respectively; P = 0.010). There were no significant differences in other parameters. (1)

 

2)   A similar study by Sachidananda et Al showed that the first-time insertion success rate of the Baska® mask was 21/24 (88%) when compared with the I-gel, which was 23/25 (92%) (p=0.585). The insertion time of the Baska® mask was 14.9±6.2 s, whereas that of the I-gel was 14.7±4.4 s (p=0.877). The mean sealing pressure of the Baska® mask was significantly higher when compared with the I-gel (28.9±3.5 vs. 25.9±2.5 cmH2O) (p=0.001). (2)

 

 

3)   According to Kara et Al, compared to I-gel, the Baska mask required a longer time for insertion, and its airway pressure was higher. The median (minimum-maximum) duration of LMA insertion in the Baska and I-gel groups was 14 (6-25) and 7 (5-12) seconds, respectively (z=-10.934; P<.001). The mean (SD) airway pressures were significantly different between the two groups (15.8 [1.9] and 14.9 [1.7] cm/H2O for Baska and I-gel, respectively; t=3.668; P<.001). Seal pressure was not significantly different between the groups (0.08 [0.2] vs. 0.07 [0.2] cm/H2O in the Baska and I-gel groups, respectively, (t=1.35; P=.194).

 

4)    Based on a study by Agarwal et Al,Oropharyngeal seal pressure was significantly higher at insertion (31.70±3.67 cmH2O versus 27.3±2.93 cmH2O respectively, p value<0.001) and after deflation of carboperitoneum (31.33±3.51 cmH2O and 28.20±3.07 cmH2O respectively, p value < 0.001) in group B than group I. Time for achieving effective airway in group B was comparable to that in group I (17.83±2.05 seconds vs17.86±1.041 seconds respectively, p value=0.937). Ease of insertion of device was comparable between the two groups (p value= 0.584). Upon fibreoptic assessment, anatomical alignment of the device to larynx was comparable between the two groups (p value =0.655).

 
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