| CTRI Number |
CTRI/2025/11/097055 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oropharyngeal leak pressure comparison between i gel and air q sp] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two types of airway devices air-q and I-gel used to help children breathe safely during general anaesthesia |
|
Scientific Title of Study
|
A Randomised comparative Study to evaluate oropharyngeal leak pressure of Self – pressurized Air-Q versus I-Gel Laryngeal Airway in pediatrict patients under general anaesthesia at SMS Medical College Jaipur |
| 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 Neelam Dogra |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLEGE, JAIPUR |
| Address |
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Dogra |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLEGE, JAIPUR |
| Address |
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna Sharma |
| Designation |
Junior resident |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8005861914 |
| Fax |
|
| Email |
chikisharma2307@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur |
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR |
| Address |
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur |
| 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 neelam dogra |
OPERATION THEATERS OF SMS MEDICAL COLLEGE, JAIPUR |
Department of anaesthesia, dhanwantari block,2nd floor,SMS medical College and attached hospital, jaipur
Jaipur
RAJASTHAN |
9928709289
neelam_dogra24@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (3) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-gel laryngeal airway |
I-gel is a second generation supraglottic airway,provide an anatomical seal without cuff inflation,standard insertion and monitoring protocol will be followed |
| Comparator Agent |
Self pressurized Air-Q Laryngeal Airway |
Self pressurized Air-Q Laryngeal Airway used to maintain airway patency during general anaesthesia ,it will be used as the comparator device,standard insertion and monitoring protocols will be followed |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Parent/guardian willing to provide consent for participation.
Patients of either sex.
age 0-5 years
weight -0-25 kg
ASA GRADE I and II
Undergoing elective surgery in supine position requiring general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Abnormal airway anatomy assessed by – inadequate mouth opening, micrognathia, thyromental distance, and submental compliance, intra oral growth.
Patient with cardiopulmonary disease
Severe gastrointestinal reflux
History of upper respiratory tract infection in previous 14 days.
Syndromic children with difficult airway, intraoral pathology. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak pressure of Self -pressurised Air-Q and I-Gel laryngeal airway measured in paediatric patients under general anaesthesia |
1.Immediately after insertion of the device
2.After 5 minutes post insertion
3.At the end of surgery befor device removal
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare fiber optic view of larynx between two study groups.
To evaluate and compare post-operative complications (laryngospasm, sore throat, dysphagia, blood staining of device) between two study groups.
To evaluate and compare hemodynamic changes between two study groups. |
Time (in min)
HR(bpm)
BP(mmHG)
MAP(mmHG)
SpO2(%)
Baseline
After Induction
After Insertion of LMA
3 mins after insertion of LMA
5 mins after insertion of LMA
10 mins after insertion of LMA
15 mins after insertion of LMA
20 mins after insertion of LMA
30 mins after insertion of LMA
40 mins after insertion of LMA
50 mins after insertion of LMA
60 mins after insertion of LMA
Time (in min)
HR(bpm)
BP(mmHG)
MAP(mmHG)
SpO2(%)
Baseline
After Induction
After Insertion of LMA
3 mins after insertion of LMA
5 mins after insertion of LMA
10 mins after insertion of LMA
15 mins after insertion of LMA
20 mins after insertion of LMA
30 mins after insertion of LMA
40 mins after insertion of LMA
50 mins after insertion of LMA
60 mins after insertion of LMA
|
|
|
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)
|
15/11/2025 |
| 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="0"
Months="2"
Days="10" |
|
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
|
A Randomised Study to compare oropharyngeal leak pressure of I-Gel v/s Self – pressurized Air-Q Laryngeal Airway in pediatric patients under general anaesthesia,To find out the effectiveness of supraglottic Airway device Air-Q SP and I-Gel in terms of oropharyngeal leak pressure in pediatric surgical patients under general anaesthesia.
|