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CTRI Number  CTRI/2022/12/047909 [Registered on: 06/12/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two airway devices in adult patients undergoing elective surgery under general anaesthesia 
Scientific Title of Study   Comparative evaluation of efficacy of two anatomically preformed supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ASWATHI S ANAND 
Designation  POST GRADUATE RESIDENT (Anaesthesia) 
Affiliation  Safdarjung Hospital and Vardhman Mahavir Medical College 
Address  Department of Anaesthesia and Intensive Care. Ground floor, Main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029

New Delhi
DELHI
110029
India 
Phone  8590449334  
Fax    
Email  aswathianjanam@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NIDHI AGRAWAL 
Designation  CONSULTANT 
Affiliation  Safdarjung Hospital and Vardhman Mahavir Medical College 
Address  Department of Anaesthesia and Intensive Care. Ground floor, Main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029

New Delhi
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR NIDHI AGRAWAL 
Designation  CONSULTANT 
Affiliation  Safdarjung Hospital and Vardhman Mahavir Medical College 
Address  Department of Anaesthesia and Intensive Care. Ground floor, Main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029

New Delhi
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung Hospital and Vardhman Mahavir Medical college, New Delhi,India 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and intensive care. Ground floor, main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029  
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 ASWATHI S ANAND  Safdarjung hospital and Vardhman Mahavir Medical College  Department of Anaesthesia and intensive care. Ground floor, main operation theatre building, Safdarjung hospital and Vardhman Mahavir Medical college, New Delhi, 110029
New Delhi
DELHI 
08590449334

aswathianjanam@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS 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 
Comparator Agent  Ambu AuraGain  Ambu AuraGain of appropriate size will be inserted as per manufacturers instructions. Before insertion cuff will be deflated completely and a sterile, water based lubricant will be applied to the posterior surface of the cuff. The airway tube will be held like a flute, with three fingers placed on the flat part of the bite absorption area and the thumb on the vertical line on the bite absorption area, which is oriented anteriorly towards the patients nose. The other hand will be placed under the patients head. The tip of the cuff will be inserted by pressing upward against the hard palate thus the flattening the cuff against it. The jaw will be gently pushed downwards with the middle finger to open the mouth further. The tip of the cuff will be placed correctly in the mouth opening and inserted by swinging the mask inward with a continuous circular motion, pressing the contours of the hard and soft palate. The Ambu AuraGain will be advanced into the hypopharynx until a definite resistance is felt, where its tip will be resting against the upper oesophageal sphincter. 
Intervention  LMA Protector  LMA Protector of appropriate size will be introduced. Cuff of the device will be fully deflated and posterior surface of the mask and airway tube will be lubricated with water soluble lubricating jelly, the patients head and neck will be placed in sniffing position . The mouth will be opened with the investigators nondominant hand. Using the dominant hand, device will be introduced in the oral cavity pressing the posterior part of the tip of the mask against the hard palate . Device will be advanced further into hypopharynx in one smooth circular movement pressing against the contours of the hard and the soft palate until definite resistance is felt. Device will be fixed to the cheeks with tape placed transversely across fixation tab. Cuff of LMA protector will be inflated with air to 60cm of water using cuff pressure gauge. Intracuff pressure will be checked every 30 minutes and adjusted to 60cm of water throughout anaesthesia. the LMA Protector cuff pilot technology will be compared to the cuff pressure measured by a manometer. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  This study will be conducted in adult patients , in age group 18 to 65 years, weighing 30 to 70 kg, ASA physical status I and II undergoing elective surgery under general anaesthesia with controlled ventilation in supine position. 
 
ExclusionCriteria 
Details  1)Patients with anticipated difficult airway
2)Mouth opening less than 3.5cm, BMI more than 30kg/m2
3)Cervical spine pathology
4)Intestinal and oesophageal pathology
5)Operation time greater than 4 hours
6)High risk of aspiration
7)Cardiac and pulmonary compromise, Hypertension
8)Poor dentition with high risk of damage
9)Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure  after device insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts taken for successful insertion of device, Time for achieving effective ventilation, Number of patients requiring manipulation for achieving effective ventilation and type of manipulation, Ease of insertion of device, Ease of gastric catheter insertion, Score regarding anatomical alignment of device  At the time of device insertion. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   12/12/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The supraglottic airway device is commonly used for airway management during anaesthesia or as an immediate life saving measurement in patients with difficult or failed airway.  The laryngeal mask protector(LMA Protector) is a new second generation supraglottic airway device made with medical grade silicon. The LMA  protector provides access tp and functional separation of the ventilation and digestive tract, with the presence of two drainage channels, which emerge proximally as separate ports and enter the chamber located behind th cuff bowl. Ambu AuraGain is a well established second generation supraglottic airway device. It has noninflatable gel like cuff made up of  medical grade thermoplastic elastomer and designed to anatomically fit the peri laryngeal structures to provide effective seal.
 This study will compare LMA Protector and Ambu AuraGain, mainly on the basis of the oropharyngeal leak  pressure, also compares other parameters during the insertion of these devices.
 
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