| CTRI Number |
CTRI/2020/07/026809 [Registered on: 27/07/2020] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of oropharangeal seal pressure in supraglottic airway devices namely "AMBUAURA GAIN" versus "I GEL" in paediatric surgery patients under general anaesthesia |
|
Scientific Title of Study
|
Comparison of oropharangeal seal pressure in supraglottic airway devices "AMBUAURA GAIN" Versus "I GEL" In paediatric surgery patients under general anaesthesia: A randomised interventional study at SMS medical college and attached group of hospitals, Jaipur during year 2019-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rama Chatterjee |
| Designation |
senior professor |
| Affiliation |
SMS medical college Jaipur |
| Address |
SMS Medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Chatterjee |
| Designation |
senior professor |
| Affiliation |
SMS medical college Jaipur |
| Address |
SMS Medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika kumari |
| Designation |
Junior resident |
| Affiliation |
SMS medical college Jaipur |
| Address |
SMS Medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
Dipika3352@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical college and attached group of hospitals, Jaipur,302004 |
|
|
Primary Sponsor
|
| Name |
department of Anaesthesiology |
| Address |
SMS Medical college and attached group of hospitals, jaipur,302004 |
| 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 Deepika kumari |
Department of anaesthesiology |
Room no. 308
2nd floor dhanvantri OT complex
Department of anaesthesiology
SMS Medical college
Jaipur
302004
Jaipur
RAJASTHAN |
9462609045
dipika3352@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMBUAURA GAIN |
AMBUAURA GAIN, a supraglottic airway device |
| Comparator Agent |
I GEL |
I GEL, a supraglottic airway device |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
Weight between 10 to 30 kg
Elective inguinal, urology procedure for which SADs are routinely used |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in study.
Patient with active respiratory infection.
Patient with difficult airway.
emergency surgeries. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine difference in oropharangeal seal pressure in both groups. |
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine the difference in mean time of insertion of device |
30 s |
| to determine % of cases with successful insertion of device |
1-2 |
| to determine difference in number of attempts for successful gastric tube insertion in both groups |
1-2 |
| to determine difference in mean grading of fiberoptic aperture visibility in both groups |
1-6 |
| to determine difference in % of cases with side effects in both groups |
0-5 |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/07/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study about comparison of supraglottic airway devices AMBUAURA gain versus I gel in paediatric patients. The study helps to provide adequate evidences to help secure paediatric airway in a safe and effective manner with least trauma and side effects and with hemodynamic stability. |