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
|
|
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
|
|
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.
|