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CTRI Number  CTRI/2025/04/084002 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ease of placement of 2 airway devices  
Scientific Title of Study   Evaluation of Ease of Insertion and Successful Placement of I-Gel and Ambu Aura Gain In Spontaneously Breathing Anaesthetized Patient  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SannapuRajitha  
Designation  Junior resident  
Affiliation  Gandhi medical College  
Address  OT complex second floor Department of anesthesiology block -1 Gandhi medical College Hamidia hospital

Bhopal
MADHYA PRADESH
462001
India 
Phone  7989987286  
Fax    
Email  raji444.rt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVikas kumar Gupta  
Designation  Associate professor  
Affiliation  Gandhi medical College  
Address  OT complex second floor Department of anesthesiology block -1 Gandhi medical College Hamidia hospital

Bhopal
MADHYA PRADESH
462001
India 
Phone  9229988164  
Fax    
Email  1074vicky@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrVikas kumar Gupta  
Designation  Associate professor  
Affiliation  Gandhi medical College  
Address  OT complex second floor Department of anesthesiology block -1 Gandhi medical College Hamidia hospital

Bhopal
MADHYA PRADESH
462001
India 
Phone  9229988164  
Fax    
Email  1074vicky@gmail.com  
 
Source of Monetary or Material Support  
Gandhi Medical College Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal MADHYA PRADESH India 462001  
 
Primary Sponsor  
Name  Gandhi Medical College Bhopal Madhya Pradesh  
Address  Sultania Royal Market Bhopal Madhya Pradesh India 462001 
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 
DrVikas Kumar Gupta  Hamidia Hospital   OT 3 Block 1 Second Floor Department of Anesthesiology Gandhi Medical College Bhopal Madhya Pradesh India 462001 
Bhopal
MADHYA PRADESH 		 9229988164

1074vicky@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee Gandhi Medical College Bhopal MP INDIA  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 
Comparator Agent  Ambu Aura Gain   Ambu Aura gain is a new anatomically curved, phthalate free, single use supraglottic airway with inflatable cuff. Additionally, because the airway tube of Ambu aura gain is wide it can be used as conduit for tracheal intubation. minimise gastric aspiration, and are associated with lower hemodynamic and metabolic stress are recommended for use in routine clinical practice, as well as to rescue failed tracheal intubation  
Comparator Agent  I Gel   I Gel is used for difficult airway emergencies lifethreatening situations and in Cardiopulmonary resuscitation for emergency airway management.It facilitate intubation by providing an unobstructed passage from mouth to glottic opening. It minimise gastric aspiration and are associated with lower hemodynamic and metabolic stress are recommended for use in routine clinical practice as well as to rescue failed tracheal intubation. The I-gel is a second-generation SAD made of thermoplastic elastomer to fit the perilaryngeal structure for effective airway management & used in both anaesthesia and resuscitation.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA grade l and ll
Age group 20 to 60 year
All patients scheduled to undergo elective surgery in the
supine position with spontaneous respiration
Duration of surgery less than one hr
 
 
ExclusionCriteria 
Details  Patients with known difficult airways
Cervical spine disease
Mouth opening less than 2 cm
History of upper gastrointestinal bleeding or
clotting abnormalities gastroesophageal reflux disease
Excluded in the study  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the ease and success rate of Ambu Auragain
and I-gel in patients for short surgical procedures with Spontaneous respiration  		 SGA insertion time after 1 min 5 min 15 min and after SGA removal number of attempts leak pressure and ease of placement will be assessed  
 
Secondary Outcome  
Outcome  TimePoints 
To observe Variation in haemodynamic parameters.  Vital monitoring baseline after induction after insertion for 1 min 5 min 15 min after removal of SGA  
 
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   N/A 
Date of First Enrollment (India)   30/04/2025 
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="11"
Days="30" 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [raji444.rt@gmail.com].

  6. For how long will this data be available start date provided 10-03-2025 and end date provided 10-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Standard anaesthesia monitoring will be established  iv access will be secured  The anaesthesia protocol will be standard patient will be preoxygenated with 100% oxygen then anaesthesia will be induced by premedication with glycopyrolate midazolom  fentanyl and induction  propofol till loss of verbal response then  SGA  will be inserted and Patients will be ventilated with oxygen and sevoflurane 2% for 3 min After  checking adequate ventilation patient is kept on spontaneous respiration while maintaining anesthesia with oxygen+N2O+sevoflurane 2-3%  Ease of SGA devices  insertion will be graded according to subject handling score easy  satisfactory  difficulty Time of successful SGA devices will be measured from insertion of SGA devices from dental arches until confirmation of successful ventilation T1  Number of attempts and manoeuvres required for SGA devices insertion will be  recorded  Maximum 2 attempts for SGA devices insertion will be taken and will be proceeded for alternative technique or endotracheal intubation depanding upon decision of anaesthesiologist  
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