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CTRI Number  CTRI/2023/05/052419 [Registered on: 09/05/2023] Trial Registered Prospectively
Last Modified On: 08/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound of airway device to assess its correct position in children undergoing general anaethesia. 
Scientific Title of Study   Utility of ultrasonography in assessing optimal I-GEL placement in children: an observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Purva Dipak Bhide 
Designation  Junior resident doctor 
Affiliation  Lokmanya Tilak Municipal Medical College and Hospital 
Address  3rd Floor, Room number 312, New RMO Hostel, opposite of gate number 7 of Sion Hospital, Department of Anaesthesiology, Sion(West) Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  8208044598  
Fax    
Email  purvabhide1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anila D Malde 
Designation  Head of the Department of Anaesthesiology 
Affiliation  Lokmanya Tilak municipal medical college and general hospital 
Address  Room number N424, 4th floor, Department of Anaesthesiology, Lokmanya Tilak Municipal medical college and hospital, Sion west, 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Purva D Bhide 
Designation  Junior Resident Doctor 
Affiliation  Lokmanyatilak municipal medical college and general hospital 
Address  3rd floor, Room number 312, New RMO Hostel, opposite of gate number 7 of Sion hospital, Department of Anaesthesiology, Sion(West) Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  8208044598  
Fax    
Email  purvabhide1994@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and General Hospital 
 
Primary Sponsor  
Name  Dr Purva Dipak Bhide 
Address  Room number 312, New RMO hostel, near Sion hospital, Sion west, Mumbai, 400022 
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 Purva Dipak Bhide  Lokmanya Tilak Municipal Medical College  Room number N424, 4th floor, department of Anaesthesiology, Lokmanya Tilak Municipal Medical College, Sion west, Mumbai 400022
Mumbai
MAHARASHTRA 
8208044598

purvabhide1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children undergoing general anaesthesia using I-GEL as a supraglottic airway device. 
 
ExclusionCriteria 
Details  Wherever USG assessment of the neck is not possible e.g.
1. Children with anterior neck mass.
2. Children with burns of anterior surface of neck.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Ultrasonography as a utility in confirming optimal position of I-Gel in children.
 
After induction of anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of ultrasonography as utility in identifying the cause of malposition of I-Gel (asymmetrical, caudad, cephalad, intraglottic placement, or epiglottis downfolding) and thereby guiding in correcting malposition of I-Gel placement.  After induction of anaesthesia and after repositioning of I-gel. 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   17/05/2023 
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   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In children, I-Gel is the most common Supraglottic Airway Device (SGAD) used to provide lung ventilation during general anaesthesia for minor superficial surgeries. 

Clinically, the position of I-Gel is assessed by symmetrical bilateral chest expansion, auscultation of the chest, absence of audible oropharyngeal leakage, square wave capnogram and the seal pressure the pressure beyond which leak starts occurring at a constant flow However, these methods do not provide information regarding the site of the leakage and hence appropriate correctional manoeuvres may not be possible.

Although fibreoptic laryngoscopy (FOL) is considered the gold standard validation tool for the direct visualization of the glottis, it gives idea about only anatomical position and does not provide functional assessment.

Ultrasound imaging is a non-invasive, fast, easy, replicable, and portable technology which can provide not only anatomical but also functional assessment of the airway.

Our study aims to assess the utility of USG to detect the optimal position of the I-Gel, the cause of malpositioning and comparison of its performance with the FOL examination, seal pressure values and clinical parameters in non paralysed patients.

After the I-Gel placement, its position will be confirmed by seal pressure values, USG examination of the neck and fibreoptic laryngoscopy.

If there is malposition of the I-Gel, appropriate correcting manoeuvres will be performed and the seal pressure assessment, USG examination of the neck and fibreoptic laryngoscopy will be repeated.

The objectives of the study are as follow:

1. To assess utility of ultrasonography in comparison to clinical parameters in confirming optimal position of I-Gel in children.

2. To assess utility of ultrasonography in comparison to Fibreoptic laryngeal view (FOL) in confirming optimal position of I-Gel in children.

3. To assess utility of ultrasonography in comparison to seal pressure in confirming optimal position of I-Gel in children.

4. To assess utility of ultrasonography in finding out the cause of suboptimal position and repositioning of I-Gel in children.


 
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