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CTRI Number  CTRI/2025/02/081275 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 23/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the success rate of two methods of removing tube that is put inside the patient during general anaesthesia  
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  No. 1051 Dept. of anaesthesiology 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  No. 1051 Dept. of anaesthesiology AIIMS Mangalagiri


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  No. 1051 Dept. of anaesthesiology AIIMS Mangalagiri


ANDHRA PRADESH
522503
India 
Phone  9740122272  
Fax    
Email  dreeshwarmv@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Mangalagiri Guntur district Andhrapradesh Pin code 522503 
 
Primary Sponsor  
Name  AIIMS 
Address  Mangalagiri Guntur district 522503 
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  All India Institute of Medical Science Mangalagiri  No. 1051 Dept. of anaesthesiology AIIMS Mangalagiri Guntur district Pincode 522503
Guntur
ANDHRA PRADESH 
9740122272

dreeshwarmv@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AEC  Insert AEC through ETT and remove ETT. Insert I gel over the AEC and follow up the patient at 0, 30 minutes and 60 minutes post surgery. 
Intervention  I gel  Insert I gel at the end of the surgery after removing endotracheal tube and follow up the patient at 0, 30 minutes and 60 minutes post surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients belonging to the age group 18 to 65 years
ASA PS I – III
Intubation difficulty score (IDS) ≤ 5Scheduled for surgery under general anaesthesia
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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 using brimacombe score  From insertion of I gel to appearance of capnograph 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic changes
Number of attempts 
During the insertion of Igel up to 10 minutes post insertion 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/04/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·       Preoperative anaesthetic fitness along with written informed consent will be obtained from all the participants by the principal investigator. Premedication in the form of Tablet Alprazolam 0.25 to 0.5 milligram and Tablet Pantoprazole 40 milligram will be administered the night before the surgery as per the institute protocol and patients will be asked to fast as per the standard recommendations. Observer 1 will allocate the participants to either of the group  as per the computer generated randomisation table The participant will remain blinded to the group allocation. In the operation theatre, after attaching standard monitoring including pulse oximetry electrocardiography and non-invasive blood pressure. Intravenous line will be secured in the non-dependent arm. Anaesthesia will be administered as per standard protocol by observer 2 . The Intubation Difficulty Sore will be calculated after the successful placement of endotracheal tube. If the score is less than 5 the patient, observer 2 will proceed with the extubation strategy as per the randomisation table. At the end of the surgery observer 2 will ensure adequate neuromuscular blockade and depth of anaesthesia before performing one of the two techniques of extubation. It will be ensured that patients will get 100% throughout the procedure. A weight-based formula as recommended by the manufacturer will be used to choose the appropriate sized Intersurgical gel. After confirming the placement of the Igel, the laryngeal alignment of the SGAD will be determined by passing an adult fibreoptic bronchoscope by observer 2The fiberoptic bronchoscope will be passed through the airway tube to a position 1 cm beyond the aperture of the tube. The fiberoptic glottic view will be scored using an established scoring system Neuromuscular blockade will be reversed once the train of four count shows at least 3 twitches. The Intersurgical gel will be removed once the patient fulfils the subjective and objective criteria of extubation. Heart rate and blood pressure changes will be monitored while removing the Intersurgical gel every min up to 10 minutes after removal. Observer 1 will follow up with the patient for complications in the postoperative recovery unit.

 

 
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