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CTRI Number  CTRI/2023/11/060186 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Three Supraglottic Airway Devices in adult patients undergoing General Anesthesia 
Scientific Title of Study   A Randomised controlled trial comparing I-gel, Ambu Auragain and Baska Mask for Fiberoptic view and Oropharyngeal Leak pressure in adult patients undergoing General Anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivek Singla 
Designation  PG 2nd year Anesthesia Resident  
Affiliation  Sardar Patel Medical Collage, Bikaner, Rajasthan 
Address  Department Of Anesthesia Sardar Patel Medical Collage Bikaner Rajasthan India 334001

Bikaner
RAJASTHAN
334001
India 
Phone  7027119454  
Fax    
Email  shivek2singla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonali Dhawan 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical Collage 
Address  Department Of Anesthesia Sardar Patel Medical Collage Bikaner Rajasthan India 334001

Bikaner
RAJASTHAN
334001
India 
Phone  9414137866  
Fax    
Email  sonaligsoni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Dhawan 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical Collage 
Address  Department Of Anesthesia Sardar Patel Medical Collage Bikaner Rajasthan India 334001

Bikaner
RAJASTHAN
334001
India 
Phone  9414137866  
Fax    
Email  sonaligsoni@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Medical Collage, Bikaner, Rajasthan 
 
Primary Sponsor  
Name  Sardar Patel Medical Collage Bikaner Rajasthan 
Address  Department of Anesthesiology, Sardar Patel Medical Collage, Bikaner, Rajasthan 
Type of Sponsor  Government medical college 
 
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 Sonali Dhawan  Sardar Patel Medical Collage, Bikaner, Rajasthan  Department of Anesthesia PBM Hospital Bikaner Rajasthan
Bikaner
RAJASTHAN 		 9414137866

Sonaligsoni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical and Research Board , Sardar Patel Medical Collage, Bikaner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (4) ICD-10 Condition: K358||Other and unspecified acute appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparing three supraglottic airway devices like I-gel, Ambu Auragain and Baska mask  Compare I-gel, Ambu Auragain and Baska Mask for Fiberoptic View and Oropharyngeal Leak Pressure in adult patient under General Anesthesia 
Intervention  Insertion of supraglottic airway devices  Under general anesthesia securing airway with use of supraglottic airway devices like I-gel or Ambu auragain or Baska Mask in 10 to 25 seconds 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA category I and II, undergoing any type of surgery in supine position under general Anesthesia be included in the study after getting informed consent. 
 
ExclusionCriteria 
Details  Patient refusal to give consent, Patients with anticipated difficult airway, having upper respiratory tract infection, patients at risk of gastroesophageal regurgitation, history of upper gastrointestinal surgery, adults having limited mouth opening and mass in pharyngeal/laryngeal cavity will be excluded from the study. The patients in whom the insertion was not successful even after three attempts will get excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Fiberoptic view and the Oropharyngeal leak pressure between I-gel, Ambu Auragain and Baska Mask after insertion   To compare the Fiberoptic view and the Oropharyngeal leak pressure between I-gel, Ambu Auragain and Baska Mask after 5 minutes of insertion 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the number of attempts, Ease of insertion, Complications between I-gel, Ambu Auragain and Baska Mask  Till the point of insertion of second and third generation of supraglottic airway devices 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2023 
Date of Study Completion (India) 02/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 Supraglottic Airway Devices are meant to provide clear airway in a quicker manner and are designed to overcome the disadvantages of endotracheal intubation like soft tissue injury, exaggerated hemodynamic response and barotrauma. The advantages of supraglottic Devices include less invasiveness, avoidance of laryngoscopy, ease of placement, improved hemodynamic stability and less airway related morbidity. The newer second and third generation supraglottic airway devices are provided with safety features of integrated bite block, gastric drainage channel and also has a higher Orpharyngeal leak pressure reducing the risk of aspiration. In this study we are comparing the fiberoptic view and oropharyngeal Leak pressure of I-gel, Ambu Auragain and Baska Mask in adult patients under general anesthesia.  
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