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CTRI Number  CTRI/2015/09/006155 [Registered on: 03/09/2015] Trial Registered Retrospectively
Last Modified On: 29/06/2015
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 airway devices named I-gel and Proseal LMA used to give anesthesia in children in different head and neck positions 
Scientific Title of Study   Comparison of I-Gelâ„¢ Airway with laryngeal mask airway prosealâ„¢ in different head and neck positions in paralysed children –prospective,randomized trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gargi Banerjee 
Designation  resident 
Affiliation  PGIMER,Chandigarh 
Address  Department of anesthesia,PGIMER,sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  gargibanerjee001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya Jain 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Department of anesthesia,PGIMER,sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  jaindivya77@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divya Jain 
Designation  Assistant Professor 
Affiliation  Postgraduate institute of medical education and research, chandigarh 
Address  Department of anesthesia,PGIMER,sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  jaindivya77@rediffmail.com  
 
Source of Monetary or Material Support  
Postgraduate institute of medical education and research,sector 12, Chandigarh 
 
Primary Sponsor  
Name  PGIMERChandigarh 
Address  Postgraduate Institute of Medical Education and Research,Sector 12, Chandigarh 
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 Gargi Banerjee  Department of anesthesia,PGIMER,Sector 12, chandigarh  PGIMER,Sector 12, chandigarh
Chandigarh
CHANDIGARH 		 9814769829

jaindivya77@rediffmail.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 
Healthy Human Volunteers  Undergoing lower limb,urological procedures. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Igel  Measuring OPLP, Fiberoptic grading,Ventilatory parameters in different head and neck positions with Igelafter 3 minutes of insertion of the device. 
Comparator Agent  Proseal LMA  Measuring OPLP, Fiberoptic grading,Ventilatory parameters in different head and neck positions with Proseal LMA after 3 minutes of insertion of the device. 
 
Inclusion Criteria  
Age From  1.50 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  children scheduled to undergo elective lower abdominal surgeries and urological procedures in supine position requiring general anaesthesia will be included in the study. 
 
ExclusionCriteria 
Details  Upper respiratory tract infection (cough, fever, rhinorrhea) at the day of surgery,Respiratory tract pathology ( oropharynx, larynx ),Anticipated difficult airway,Children at increased risk of aspiration - Gastro esophageal reflux disease, non fasting status,Hiatus hernia,Lung diseases,Cardiorespiratory or cerebrovascular disease and Limited head and neck movements.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the oropharyngeal leak pressure of I gel with LMA Proseal in different head and neck positions i.e. neutral, maximum flexion, maximum extension.   After 2 minutes of each position change namely after flexion,extension and neutral. 
 
Secondary Outcome  
Outcome  TimePoints 
• We will also compare ease of insertion, insertion attempts, manoeuvres required, failed attempt and the hemodynamic response to insertion of the device. The ventilation scoring, Fiberoptic grading and passage of gastric tube in neural, maximum flexion and maximum extension with both the study devices will also be compared  ease of insertion, insertion attempts, manoeuvres required, failed attempt-Just after insertion of the device
Hemodynamic response- every minute after intubation till 10 minutes of insertion of the device 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/08/2014 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   We wish to compare the oropharangeal leak pressures, ventilatory parameters with Proseal LMA and I-gel  in different head and neck positions of neutral, maximum flexion and maximum extension  in anesthetised, paralysed children.
We would also compare ryle’s tube insertion and fiberoptic grading in these three head and neck positions.
 
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