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CTRI Number  CTRI/2016/12/007579 [Registered on: 14/12/2016] Trial Registered Retrospectively
Last Modified On: 14/12/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical trial to study the success of re-intubation over Airway Exchange catheter, with or without I-Gel (a supra-glottic airway device) as a conduit. 
Scientific Title of Study   PROSPECTIVE RANDOMISED STUDY TO COMPARE REINSERTION OF ENDOTRACHEAL TUBE OVER AIRWAY EXCHANGE CATHETER (AEC) ALONE OR OVER AIRWAY EXCHANGE CATHETER WITH I-GEL AS A CONDUIT. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anant Shukla 
Designation  Doctor 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Anaesthesia office Department of Anaesthesia BL Taneja block Third floor Maulana azad medical college New delhi-02

Central
DELHI
110002
India 
Phone  9999296429  
Fax    
Email  anantanantshukla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Bhardwaj 
Designation  Professor 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Anaesthesia office Department of Anaesthesia BL Taneja block Third floor Maulana azad medical college New delhi-02

Central
DELHI
110002
India 
Phone  9968604220  
Fax    
Email  manojb8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anant Shukla 
Designation  Doctor 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Anaesthesia office Department of Anaesthesia BL Taneja block Third floor Maulana azad medical college New delhi-02

Central
DELHI
110002
India 
Phone  9999296429  
Fax    
Email  anantanantshukla@gmail.com  
 
Source of Monetary or Material Support  
Anaesthesia department, BL Taneja block, third floor, Maulana azad medical college, new delhi -110002 
 
Primary Sponsor  
Name  maulana azad medical college 
Address  Anaesthesia office, BL Taneja block, third floor, Maulana azad medical college, new delhi -110002 
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 Anant Shukla  Maulana azad medical college  Anaesthesia department, B.L.Taneja block, third floor, Maulana azad medical college, new delhi-110002
Central
DELHI 		 9999296429

anantanantshukla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy American society of anaesthesiologists (ASA) grade - I/II patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AEC.  AEC (Airway exchange catheter) assisted reinsertion of endotracheal tube. 
Intervention  i-gel.  An i-gel will increase success rate of AEC(airway exchange catheter) assisted reinsertion of endotracheal tube or not. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults having ASA Grade I or II physical status. 
 
ExclusionCriteria 
Details  1.) Predicted difficult airway as shown by one/more of the following
i. MMP class > II
ii. Inter incisor gap<3cms
iii. Thyromental distance<6cms
iv. Sternomental distance <12cms
v. Neck motion<90°
vi. Neck circumference>40cms
2.) Perioperative airway deterioration.
3.) Patients at an increased risk of aspiration, including pregnant patients.
4.) Nasogastric tube in situ at the time of extubation. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Success rate (in %) of reinsertion of endotracheal tube, over airway exchange catheter, in both the groups  After the completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Manoeuvres needed for success of re-intubation
 		 yes/no 
Time
 		 seconds 
Haemodynamic response to re-intubation  change in heart rate, B.P. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2012 
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="1"
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  

IMPLICATION STATEMENT & BACKGROUND:  Extubation related airway problems are underestimated and under-reported. Airway exchange catheters (AEC) and supra-glottic airway device (SAD) supported extubation are now well established. This study explores whether the combination of AEC inside a SAD (i-gel in this case) be synergistic or not.

 

METHODS: One hundred ASA I/II patients were randomized to tracheal intubation using AEC alone (n=50) or over iGel with AEC (n=50) in situ. At the end of surgery, after adequate reversal and maintaining sedation using fentanyl and 2% Isoflurane, AEC was inserted and patient’s trachea extubated in one group. In the other group, iGel was slid over the AEC following extubation. Thereafter, ETT was re-inserted over AEC with or without iGel as conduit. First attempt and overall intubation success rates were evaluated and tracheal intubation times were measured.

 


 
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