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CTRI Number  CTRI/2022/08/044742 [Registered on: 18/08/2022] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of performance of Ambu Aura Gain and I gel in fatty female patients undergoing short duration surgeries under general anaesthesia  
Scientific Title of Study   Clinical performance evaluation of Ambu- Aura Gain versus I-gel in Obese female patients undergoing Short duration Surgeries under general anesthesia (CAAIOSS): a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suparna Mitra Barman 
Designation  Consultant 
Affiliation  Tata Medical Center, Kolkata 
Address  Department of Anaesthesia, critical care and pain, E-W,Major Arterial Road, New Town, Kolkata-700160
Department of Anaesthesia, critical care and pain,14 E-W,Major Arterial Road, New Town, Kolkata-700160
North Twentyfour Parganas
WEST BENGAL
700160
India 
Phone    
Fax    
Email  suparna.barman@tmckolkata.com  
 
Details of Contact Person
Scientific Query
 
Name  Suparna Mitra Barman 
Designation  Consultant 
Affiliation  Tata Medical Center, Kolkata 
Address  Department of Anaesthesia, critical care and pain, 14 E-W,Major Arterial Road, New Town, Kolkata-700160
Department of Anaesthesia, critical care and pain, 14 E-W,Major Arterial Road, New Town, Kolkata-700160
North Twentyfour Parganas
WEST BENGAL
700160
India 
Phone    
Fax    
Email  suparna.barman@tmckolkata.com  
 
Details of Contact Person
Public Query
 
Name  Suparna Mitra Barman 
Designation  Consultant 
Affiliation  Tata Medical Center, Kolkata 
Address  Department of Anaesthesia, critical care and pain, 14 E-W,Major Arterial Road, New Town, Kolkata-700160
Department of Anaesthesia, critical care and pain,14 E-W,Major Arterial Road, New Town, Kolkata-700160
North Twentyfour Parganas
WEST BENGAL
700160
India 
Phone    
Fax    
Email  suparna.barman@tmckolkata.com  
 
Source of Monetary or Material Support  
Tata Medical Center, Kolkata 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Other [nil] 
 
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 Suparna Mitra Barman  Tata Medical Center  Operation theatre, Department of Anaesthesia, critical care and pain, 14 MAR (E-W), New Town, Pin-700160
North Twentyfour Parganas
WEST BENGAL 
8017552743

suparna.barman@tmckolkata.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Medical Center Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ambu-Aura Gain  Oro pharyngeal leak pressure (OLP) at 1 minute after insertion of Ambu-Aura Gain 
Comparator Agent  I-gel  Oro-pharyngeal leak pressure (OLP) at 1 minute after insertion of I-gel 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1. Duration of surgery less than 3 hours
2. American society of anesthesiologists class(ASA) 1,2,3
3. Body mass Index more than 30kg/m2 
 
ExclusionCriteria 
Details  1. Emergency surgery
2. ASA more than 3
3. History of Cervical spine disorder or surgery
4. Risk of aspiration
5. Anticipated difficult airway
Surgery requiring pneumo-peritoneum,
trendelenburg, lateral or prone positioning, surgery in head and neck region or involving the airway 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
OLP after insertion of SAD  OLP after insertion of SAD at 1 minute 
 
Secondary Outcome  
Outcome  TimePoints 
1. OLP after insertion of SAD
2. Time of insertion
3. No of insertion attempts
4. Ease of insertion
5. Additional airway maneuvers during insertion and maintenance
6. Fibreoptic bronchoscopic view
7. Ease of suction catheter placement
8. Ventilation quality
9. Complications
 
at 30 minutes 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/08/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Supraglottic airway devices (SAD) have been used to secure and maintain airways in patients during surgery or emergency situations, as well as in the management of expected and unexpected difficult airways. I-gel is a second-generation SAD which has a soft non-inflatable cuff and a gastric access port, has been widely used in patients undergoing surgery under general anesthesia. A third-generation SAD, Ambu Aura Gain, has an inflatable cuff and a gastric port. One of the key features of the Ambu Aura Gain is the 90-degree angulated shaft, following the anatomy of the upper airway, which facilitates proper insertion and is associated with a high success rate for insertion. To compare the clinical performance of Ambu Aura Gain versus I-gel in patients undergoing breast surgery under general anesthesiaPatients who will undergo elective breast surgery will be randomized either to the Ambu Aura Gain group (group A) or the Igel group (Group B) (Sample size of 40 in each group). In both the groups, general anesthesia will be administered. For patients allocated to Group A, airway will be secured with Ambu Aura Gain of appropriate size (as per manufacturer’s recommendation). For patients allocated to Group B, airway will be secured with I-gel of appropriate size (as per manufacturer’s recommendation). Primary outcome to be observed will be oropharyngeal leak pressure (OLP) at 1 minute after insertion. Secondary outcome to be observed are: oropharyngeal leak pressure (OLP) at 30 minute after insertion, time and ease of insertion of SAD, no of insertion attempts, additional airway maneuvers during insertion and maintenance, fibreoptic bronchoscopic view score, ease of suction catheter placement, ventilation quality, complications. All statistical analyses will be performed using the Statistical Package for the Social Sciences software, v22.0 (SPSS Inc., Chicago, IL, USA).


 
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