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
|
|
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
|
|
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. |