| CTRI Number |
CTRI/2017/04/008357 [Registered on: 17/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare two instruments (LMA Supreme and I-gel) used for securing breathing passage under anaesthesia in patients undergoing elective surgeries |
|
Scientific Title of Study
|
Comparison of clinical performance of Laryngeal Mask Airway Supreme and I-Gel in patients undergoing elective non-laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Gogia |
| Designation |
DNB student |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Dept of Anaesthesia, Jaipur Golden Hospital,plot no. 2, Yog Ashram Marg, Sector 3, Institutional area, Rohini
North West
DELHI
110085
India |
| Phone |
|
| Fax |
|
| Email |
smitagogia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monica Gupta |
| Designation |
Associate Consultant |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Dept of Anaesthesia, Jaipur Golden Hospital, Plot no. 2, Yog Ashram Marg, Sector 3, Institutional area, Rohini
North West
DELHI
110085
India |
| Phone |
9811302428 |
| Fax |
|
| Email |
monaansh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Monica Gupta |
| Designation |
Associate Consultant |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Dept of Anaesthesia, Jaipur Golden Hospital, Plot no. 2, Yog Ashram Marg, Sector 3, Institutional area, Rohini
North West
DELHI
110085
India |
| Phone |
9811302428 |
| Fax |
|
| Email |
monaansh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Jaipur Golden Hospital, plot no.2, Yog Ashram Marg,Sector 3, Institutional area, Rohini, Delhi, 110085 |
|
|
Primary Sponsor
|
| Name |
Jaipur Golden Hospital |
| Address |
Dept of Anaesthesia, Jaipur Golden Hospital, plot no. 2, Yog Ashram Marg, Sector 3, Institutional area , Rohini, Delhi 110085 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Monica Gupta |
Dept of Anaesthesia, Jaipur Golden Hospital, plot no. 2, Yog Ashram Marg, Sector 3, Institutional area, Rohini, Delhi, 110085 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Gogia |
Jaipur Golden Hospital |
Department of Anaesthesia,first floor,Plot no. 2, Yog Ashram Marg, Sector 3, Institutional area, Rohini
North West
DELHI |
9650243154
smitagogia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Comparison of two airway devices in patients undergoing elective surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-Gel |
It is a new type of single use supraglottic device.It is cuffless made from a gel like thermoplastic elastomer. |
| Intervention |
Laryngeal Mask Airway Supreme |
It is a new type of single use supraglottic airway device with an anatomically shaped airway tube and a drain tube designed for passage of gastric tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex aged between 18 & 60 years
2.Patients with ASA physical status 1 and 2
3.Patients scheduled for elective non laparoscopic surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patients with high risk of aspiration
2.Morbid obesity
3.Cervical spine disease
4.Anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Ease of insertion and time taken for insertion of both the devices
2.Airway sealing pressure with both the devices |
At the time of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ease of gastric tube insertion
2.Oral or Dental trauma
3.Post op sore throat,hoarseness |
At the time of intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The latest supraglottic devices like LMA Supreme and I-Gel have been developed to overcome the limitations of currently available supraglottic devices like high cost, demand for careful handling to prevent cuff damage, relative difficulty of insertion and growing concern over the ability to use clean reusable devices.
In this randomized parallel group study we attempt to compare LMA Supreme and I-Gel in anesthetized patients undergoing non laparoscopic surgeries , in terms of ease of insertion, airway sealing pressure, insertion attempts, ease of gastric tube placement, oral or dental trauma, post operative sore throat or hoarseness. Eighty patients aged 18 to 60 years of either sex of ASA physical status 1 and 2 undergoing elective non laparoscopic surgeries will be studied.
|