| CTRI Number |
CTRI/2019/05/019405 [Registered on: 29/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out which technique of i-gel insertion is better then each other |
|
Scientific Title of Study
|
Comparison of malposition of i-gel in paediatric patients after blind and C-MAC guided insertion- A Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur Jodhpur RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9460429221 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur Jodhpur RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India
RAJASTHAN
342005
India |
| Phone |
9460429221 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur Jodhpur RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India
RAJASTHAN
342005
India |
| Phone |
9460429221 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Basni phase 2 Jodhpur 342005 |
| 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 |
| Rakesh Kumar |
All India Institute of Medical Sciences Jodhpur |
Department of anesthesia
and Critical care
OPD building, 3rd floor OT Complex AIIMS Jodhpur
Jodhpur
RAJASTHAN |
9460429221
drrakeshspmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee, All India Institute of Medical Sciences Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C-MAC |
C-MAC Videolaryngoscope will be used to guide insertion of i-gel device. |
| Comparator Agent |
Conventional |
Convention technique or blind insertion of i-gel. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist (ASA) physical status I and II, aged between 2 to 5 years, scheduled for elective surgery in supine position under general anaesthesia will be enrolled |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway, having upper respiratory tract infection, patients at risk of gastroesophageal regurgitation, history of upper gastrointestinal surgery, children having limited mouth opening, mass in pharyngeal/laryngeal cavity and syndromic babies will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of malposition between two insertion techniques (Blind vs C-MAC guided) of i-gel where the correct position will be confirm by using flexible laryngoscope |
To compare the incidence of malposition between two insertion techniques (Blind vs C-MAC guided) of i-gel where the correct position will be confirm by using flexible laryngoscope five minute after induction of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the insertion characteristics (number of attempts, ease of insertion and time required for successful insertion) of i-gel.
To compare Oropharyngeal seal pressure (OPLP) between the two techniques.
To compare any untoward event eg. sore throat, nerve injuries etc
|
at time of insertion then intraoperatively and lastely at time of extubation |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2019 |
| Date of Study Completion (India) |
25/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
. The use of supraglottic airway (SGA) has also been increased in routine airway management during general anaesthesia practice.Paediatric SGA devices have also become popular and are being used in over 50% of general anaesthetic procedures as reflected by a survey of the Association of Paediatric Anaesthetists of Great Britain and Ireland.Blind insertion often result in malposition of supraglottic airway with incidence ranging from 50-80%, as confirmed by various imaging studies including magnetic resonance image(MRI), computer tomography scan (CT) and X-ray soft tissue neck.The use of VL for SGA placement in paediatric patients have not been studied yet. Hence, this study is planned to compare the conventional versus C-MAC guided insertion of i-gel in paediatric patient. We hypothesize that C-MAC guided insertion will result in better positioning of i-gel compared to blind insertion in paediatric patients undergoing surgery in supine position |