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CTRI Number  CTRI/2024/01/061401 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 11/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare two methods of removal of a tube at the end of anaesthesia using a device called I-gel 
Scientific Title of Study   Comparison of success rates of two techniques of extubation over supraglottic airway device (I-gel) in patients with unanticipated difficult airway  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  EESHWAR M V 
Designation  Assistant Professor 
Affiliation  AIIMS MANGALAGIRI 
Address  Room no.425, Department of Anesthesia, AIIMS, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9740122272  
Fax    
Email  dreeshwarmv@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Scientific Query  
Name  EESHWAR M V 
Designation  Assistant Professor 
Affiliation  AIIMS MANGALAGIRI 
Address  Room no.425, Department of Anesthesia, AIIMS, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9740122272  
Fax    
Email  dreeshwarmv@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query  
Name  EESHWAR M V 
Designation  Assistant Professor 
Affiliation  AIIMS MANGALAGIRI 
Address  Room no.425, Department of Anesthesia, AIIMS, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9740122272  
Fax    
Email  dreeshwarmv@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Mangalagiri, Andhra Pradesh 
 
Primary Sponsor  
Name  AIIMS Mangalariri 
Address  Dept of Anaesthesia, Room. 425, AIIMS, Mangalagiri 
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 Eeshwar M V  AIIMS Mangalagiri  Room No. 425, 4th floor Department of Anesthesia
Guntur
ANDHRA PRADESH 		 9740122272

dreeshwarmv@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Mangalagiri Institute ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Airway exchange catheter (AEC)  Use the AEC to insert the I-gel and compare the first attempt success rate with that of I-gel alone. 
Intervention  I-gel  Replace the endotracheal tube with I-gel at the end of the surgery and look for 1st attempt success rate in proper placement. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients belonging to the age group 18 to
65 years
2.ASA PS I – III
3.Intubation difficulty score (IDS) ≤ 5
4.Scheduled for surgery under general anaesthesia
 
 
ExclusionCriteria 
Details  2.IDS > 5
3.Predictors of difficult LMA insertion
4.Patients who are at risk of aspiration
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to compare the success rate of placement of I-gel (SGAD) using the Airway Exchange Catheter (AEC) technique with Asai’s technique in patients with an unanticipated difficult airway.  At 1 min after the successful insertion of I-gel using either of the 2 techniques, FOB will be performed to grade the view of the laryngeal inlet 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes which will be evaluated are the haemodynamic changes, the time & number of attempts taken to insert the I-gel, 1st attempt success rate, the grade of laryngeal view attained using a fibreoptic bronchoscope, the incidence of other airway-related complications like sore throat, trauma, laryngospasm & bronchospasm in the perioperative period.  Haemodynamics will be monitored at 1 min, 5min & 10min after insertion of the I gel
Post operative sore throat will be assessed at 30 min, 1 hour & 24 hours post operative period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/02/2024 
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   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Extubation marks the period of transition from an established airway to a normal natural airway. Similar to intubation, extubation is associated with numerous complications such as bronchospasm, laryngospasm, airway obstruction etc. These can lead to extubation failure and reintubation. Extubation is also associated with haemodynamic stress response which cannot be tolerated in patients with underlying cardiovascular disease, or in patients undergoing intracranial or intraocular surgeries.  All of these increase morbidity and mortality. NAP4 reported a mortality of 5% in patients with extubation failure after general anaesthesia. The Difficult Airway Society (DAS) guidelines and also the recent All India Difficult Airway Guidelines (AIDAA) mention the use of supraglottic airway devices (SGAD) as a rescue device in the event of a failed intubation and also as a bridge to extubate patients in whom the haemodynamic stress response needs to be attenuated. Asai and later Raveendran et al described two techniques of extubation over a SGAD. The SGAD devices used in these techniques are classic LMA and Proseal LMA respectively. We plan to use I-gel, a novel device that has been time-tested. 
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