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CTRI Number  CTRI/2013/02/003364 [Registered on: 08/02/2013] Trial Registered Retrospectively
Last Modified On: 04/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative study of two different type of airway tubes in infants, for short surgeries  
Scientific Title of Study   A Comparative study of LMA size-1 vs i-gel size-1 in infants undergoing daycare procedures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EC/04/11/243  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepanjali Pant 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital New Delhi  
Address  Dept of Anaesthesiolog Pain & Perioperative Medicine Sir Ganga Ram Hospita New Delhi

Central
DELHI
110060
India 
Phone  01142252513  
Fax    
Email  deepanjalipant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepanjali Pant 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital New Delhi  
Address  Dept of Anaesthesiolog Pain & Perioperative Medicine Sir Ganga Ram Hospita New Delhi

Central
DELHI
110060
India 
Phone  01142252513  
Fax    
Email  deepanjalipant@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archna Koul 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram Hospital New Delhi 
Address  Dept of Anaesthesiology Pain & Perioperative Medicine Sir Ganga Ram Hospital New Delhi

Central
DELHI
110060
India 
Phone  01142252513  
Fax    
Email  archnakoul1@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesiology Pain Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi  
 
Primary Sponsor  
Name  Dept of Anaesthesiology Pain Perioperative Medicine 
Address  Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi - 110060 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Archna Koul  Sir Ganga Ram hospital   Department of Anaesthesiology, Pain & Perioperative Medicine Sir Ganga Ram Hospital, New Delhi
Central
DELHI 
01142252513

archnakoul1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sir Ganga Ram Hospital Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Lower abdominal surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  i-gel size 1  comparison of i-gel size 1 with laryngeal mask airway size 1 in paedriatric patients undergoing daycare procedures 
Comparator Agent  Laryngeal Mask Airway size 1  comparison of i-gel size1 with laryngeal mask airway size 1 in paedriatric patients undergoing day care surgeries 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  1. ASA grade I/II
2. Weight 2Kg to 5 Kg 
 
ExclusionCriteria 
Details  1. ASA physical status greater than II
2. Risk of pulmonary aspiration
3. Potential difficult airway
4. Children who require surgery in positions other than supine or lithotomy

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Seal pressure achieved   From induction af anaesthesia to awakening from anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1. Ease of insertion
2. Stability of the device

 
From induction af anaesthesia to awakening from anaesthesia 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/09/2011 
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="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The laryngeal mask airway and similar supraglottic devices use an inflatable cuff to wedge into the upper oesophagus and provide a perilaryngeal seal. Inflatable masks provide an airway seal but can have negative impact on how these devices are inserted, how they are positioned and how they can perform. Inflation using the recommended volumes increases mask rigidity and decreases conformity with perilaryngeal structures. Mechanically, inflation can cause movement of the device. Inflatable masks also have the potential to cause tissue distortion, venous compression and nerve injury. Depending upon their material they can absorb anaesthetic gases leading to increased mucosal pressures. Size 1 LMA which is used in children upto 5 kg is vulnerable to displacement with slight movement of head of the child or anaesthesia circuit or with cuff inflation.

Currently the classical supralaryngeal airway devices (SAD) have been modified and i-gelTM airway is one of the alternative SADs which has been recently introduced.

The i-gel airway (Intrasurgical Ltd, Wokingham, Berkshire, UK) is a novel, single patient use, disposable supraglottic device made up of a thermoplastic elastomer (SEBS, styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel like feel. It is designed to achieve a mirrored impression of the pharyngeal and laryngeal structures and to provide perilaryngeal seal without cuff inflation. A supraglottic airway without a cuff has potential advantages including easier insertion and use, minimal risk of tissue compression, stability after insertion (i.e. no position change with cuff inflation) 
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