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CTRI Number  CTRI/2015/06/005905 [Registered on: 10/06/2015] Trial Registered Retrospectively
Last Modified On: 06/06/2015
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 supraglottic airway devices air-Q ILA and i –gel for maintaining ventilation under general anaesthesia  
Scientific Title of Study   Comparison of air-Q ILA and i –gel supraglottic device in airway management during general anaesthesia – a randomised 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  BALAJI K 
Designation  JUNIOR RESIDENT 
Affiliation  JIPMER 
Address  BALAJI K JUNIOR RESIDENT DEPT OF ANAESTHESIA JIPMER PUDUCHERRY

Pondicherry
PONDICHERRY
605 006
India 
Phone  9688663021  
Fax    
Email  balajikresan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Suman Lata Gupta 
Designation  Associate Professor,Anaesthesiology And Crtical Care,JIPMER 
Affiliation  JIPMER 
Address  Dept. of Anaesthesiology and Critical Care JIPMER PUDUCHERRY

Pondicherry
PONDICHERRY
605 006
India 
Phone  9488830091  
Fax    
Email  sumanlatagupta13@gmal.com  
 
Details of Contact Person
Public Query  
Name  BALAJI K 
Designation  JUNIOR RESIDENT 
Affiliation  JIPMER 
Address  BALAJI K JUNIOR RESIDENT DEPT OF ANAESTHESIA JIPMER PUDUCHERRY

Pondicherry
PONDICHERRY
605 006
India 
Phone  9688663021  
Fax    
Email  balajikresan@gmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER PONDICHERRY 
Type of Sponsor  Research institution and hospital 
 
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 SANDEEP MISHRA  JIPMER  Department of Anaesthesiology and Critical Care, Main OT Complex, SSB OT Complex and WCH OT complex.JIPMER PONDICHERRY
Pondicherry
PONDICHERRY 		 9344668104

jipmermishra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ● ASA class 1 & 2 patients requiring general anaesthesia for elective surgery in JIPMER of age 18 to 60 year ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  air q  air-Q® Masked Laryngeal Airways Disposable(mercury medicals) will be secured under standard anaesthesia technique. Intubation through the airway channel of air-Q® will be attempted. If not succeed it will be done under fiberoptic guidance.  
Comparator Agent  i gel  I-gel (Inter surgical Ltd) will be secured with standard anaesthesia technique and intubation through the airway channel of i-gel will be attempted. If not succeed it will be done under fiberoptic guidance.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA class 1 & 2 patients requiring general anaesthesia for elective surgery in JIPMER  
 
ExclusionCriteria 
Details  1 Any pathology of the neck, upper respiratory tract or upper alimentary tract.
2 Predicted difficult airway,
3 A body mass index >35 kg/m2.
4 Patients with history of obstructive sleep apnea.
5 Patients at risk of pulmonary aspiration of gastric contents
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the success rate of endotracheal intubation through both devices  during perioperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following parameters in both devices
No of attempts in device insertion and endotracheal intubation
Ease of insertion of S.G.A
Device insertion time and ET intubation time
Device removal time
 		 during perioperative period 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/12/2013 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

AIMS AND OBJECTIVES

Primary aim

—  To compare the success rate of endotracheal intubation through both devices

Secondary  aim

                To compare the following parameters in both devices

  •  No  of attempts in device insertion & endotracheal intubation
  • Ease of insertion of S.G.A
  • Device insertion time & ET intubation time
  • Device removal time

                               Hypothesis:

AIR Q is better than I-Gel   in terms of blind intubation  for patients under General anesthesia 

 
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