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CTRI Number  CTRI/2025/06/089121 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between The two techniques of I-GEL insertion  
Scientific Title of Study   Comparative study of two techniques of I-GEL Insertion modified Jaw Thrust and Reverse Technique of I-GEL Insertion by new Trainees in patient undergoing General Anaesthesia – A Randomized Clinical Trial 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhavi chaudhari 
Designation  Professor of Department of anaesthesiology 
Affiliation  Pramukhswami medical college, Bhaikaka University 
Address  Department of anaesthesiology,HM patel center for medical care and education, Karamsad -388325, Anand, Gujarat, India

Anand
GUJARAT
388325
India 
Phone  9427084963  
Fax    
Email  madhavic@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi Chaudhari 
Designation  Professor of department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College, Bhaikaka University 
Address  Department of Anaesthesiology, HM Patel center for Medical care and education, Karamsad, Anand, Gujarat,India

Anand
GUJARAT
388325
India 
Phone  9687806182  
Fax    
Email  madhavic@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr RIya Patel 
Designation  Resident doctor of department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College, Bhaikaka University 
Address  Department of anaesthesiology, HM patel center for Medical Care and Education, Karamsad,anand,Gujarat,India

Anand
GUJARAT
388325
India 
Phone  9687806182  
Fax    
Email  rp8303611@gmail.cm  
 
Source of Monetary or Material Support  
SHREE KRINSHNA HOSPITAL ,karamsad-388325,Anand,Gujarat, India 
 
Primary Sponsor  
Name  Shree Krishna hospital 
Address  Shree Krishna hospital, Pramukh Swami medical college, Karamsad,Anand 
Type of Sponsor  Private 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 Riya Patel  Shree krishna hospital   112,Department of Anaesthesiology,Pramukh Swami Medical college,Karamsad-388325, Anand,Gujarat,India
Anand
GUJARAT 
9687806182

rp8303611@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- 2,Bhaikaka University, Karamsad, Anand, Gujarat- 388325  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nill  nill 
Comparator Agent  nill  nill 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient willing to sign the written informed consent.
Belonging to ASA grade 1, 2 ,3.
Male or female between the age range of 18-80 years.
Surgery in supine position.
Patient undergoing elective surgeries for duration more than 15min to less than 8 hours under general anaesthesia.
Procedure will be performed by new trainees.

 
 
ExclusionCriteria 
Details 

• Patients unwilling to participate.
• Patients belonging to ASA grade 4 or more.
• Pregnant and lactating women.
• Age below 18 years.
• Known case of Esophageal disease (cancer, varices)
• Patient with gastroesophageal reflex disease, abnormal head and neck, airway abnormality.
• Limited mouth opening (less than 2 finger).
• Local pathology in pharynx, larynx or upper airway .
• Surgery in prone position.
• Morbidly obese (BMI 40 or more).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare time taken for I-GEL insertion on 1st attempt by Modified jaw thrust and Reverse technique by new trainees  To compare time taken for I-GEL insertion on 1st attempt by Modified jaw thrust and Reverse technique by new trainees,Time taken from I-gel insertion to first ventilation is less than 60 seconds, 60 to 120 seconds,more than 120 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Post operative sore throat between two techniques within 1 hour of I-gel removal
 
0- No sore throat
1-Mild sore throat
2-Moderate sore throat
3-Severe sore throat within 1 hour of I-gel removal
 
Secondary Objectives: 1) To compare the success rate between the two techniques.
 
 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   01/07/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Supraglottic airway devices (SADs), like the I-gel, are increasingly utilized in anesthesia and emergency care due to their ease of insertion and reduced invasiveness compared to tracheal intubation. The I-gel, a second-generation SAD with a thermoelastic cuff, is designed to conform to the patient’s anatomy, minimizing trauma during insertion. However, standard insertion techniques can sometimes be hindered by anatomical challenges, such as tongue folding or resistance in the oropharynx.

To address these challenges, several alternative insertion techniques have been developed:

  • Modified Jaw Thrust Technique: This method involves the operator using their little fingers to lift the mandible while stabilizing the jaw with the other fingers, allowing the thumbs to advance the I-gel into position. This technique has demonstrated a 100% first-attempt success rate in a case series, with an average insertion time of approximately 11 seconds and minimal trauma.

  • Reverse Insertion Technique: In this approach, the I-gel is inserted with its concavity facing the hard palate. Upon reaching the oropharynx, it is rotated 180° into its final position. This method has been effective in cases where the standard technique failed due to tongue folding.

  • Rotational Technique: This technique involves rotating the I-gel 90° during insertion to reduce tongue folding and facilitate smoother placement. Studies have shown higher first-attempt success rates with this method compared to the standard technique.

These alternative techniques can be particularly beneficial for trainees or in scenarios where standard insertion proves challenging. Implementing these methods may improve insertion success rates and reduce complications associated with airway management.

 
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