| CTRI Number |
CTRI/2025/03/083001 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In paediatric population, 2 types of supraglottic airway devices will be used - Igel and Classic laryngeal airway and their ease of insertion and variation in vitals of the patient will be compared.
|
|
Scientific Title of Study
|
A comparative study of ease of insertion and hemodynamic
parameters between Supraglottic airway device - Igel and Classic Laryngeal
Mask Airway , in paediatric patients – A prospective randomized study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Christina George |
| Designation |
professor |
| Affiliation |
Christian Medical College and Hospital, Ludhiana, Punjab |
| Address |
Department of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
8146650178 |
| Fax |
|
| Email |
23cgeorge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elzeba Susan Varghese |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital, Ludhiana, Punjab |
| Address |
Department of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
8281430469 |
| Fax |
|
| Email |
elzebasusan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elzeba Susan Varghese |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital, Ludhiana, Punjab |
| Address |
Department of Anaesthesia, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
8281430469 |
| Fax |
|
| Email |
elzebasusan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab |
|
|
Primary Sponsor
|
| Name |
Christian Medical College and Hospital |
| Address |
Christian Medical College and Hospital, Ludhiana, Punjab |
| 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 Christina George |
Christian Medical College and Hospital |
Department of Anaesthesia , First floor,Christian Medical College and Hospital,Brown Road, Ludhiana, Punjab,Code-141008
Ludhiana
PUNJAB |
8146650178
23cgeorge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Biomedical and Health Research, Christian Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative evaluation of ease of insertion and hemodynamic parameters between I-gel and Classic Laryngeal Mask Airway |
Patients in group 1 - I-Gel will be used as airway conduit(supralaryngeal airway device) to secure the airway during general anaesthesia in elective surgery |
| Comparator Agent |
Comparative evaluation of ease of insertion and hemodynamic parameters between I-gel and Classic Laryngeal Mask Airway |
Patients in group II- Classic Laryngeal Mask Airway will be used as airway conduit(supralaryngeal airway device) to secure the airway during general anaesthesia 8n elective surgery |
|
|
Inclusion Criteria
|
| Age From |
4.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 4 months to 6 years , males and females.
2.Patients whose guardians provide us with informed consent.
3.American Society of Anaesthesiologists (ASA) class I and II.
4.Scheduled for elective surgical procedures less than one and half hour.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not providing consent.
2.Patients having difficult airway , restricted mouth opening.
3.Patient with risk of aspiration.
4.Patients with upper respiratory tract infection.
5.Patient with bleeding and clotting abnormality.
6.Patient with Oesophageal trauma.
7.Patients with congenital heart disease.
8.Patients with history of upper gastrointestinal surgery.
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the ease of insertion , hemodynamic parameters and complications following insertion of I-gel versus Classic Laryngeal mask airway in children |
Immediately after insertion,1 minute, 3 minutes, 5 minutes and 10 minutes after insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the hemodynamic parameters and complications following the removal of I-gel and Classic laryngeal mask airway in children |
Immediately after removal, 5 minutes and 20 minutes after removal |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/03/2025 |
| 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="6"
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
|
The use of Supraglottic airway devices in paediatric anaesthesia has increased recently in
view of recent advancement in ambulatory surgeries . The most commonly used is the
Laryngeal mask airway – Classic which are equipped with an inflatable cuff for sealing the
perilaryngeal space . I-gel is a new single use supraglottic airway device without an inflatable
cuff. The Aim of the study is to compare the ease of insertion , airway sealing ability and assess hemodynamic parameters
and complications in children following insertion of I-gel versus Classic Laryngeal Mask Airway
(LMA) in children . This will be a prospective observational study that will be conducted in the department of
Anaesthesia of Christian Medical College and Hospital Ludhiana , in 70 paediatric patients (4
months to 6 years) belonging to American Society of Anaesthesiologists (ASA) I-II .Computer
generated random assignation will be done – Group I – I gel and Group II- cLMA will be used. |