| CTRI Number |
CTRI/2018/12/016614 [Registered on: 11/12/2018] Trial Registered Prospectively |
| Last Modified On: |
11/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three techniques of insertion of i-gel with respect to time of insertion, failure rate. |
|
Scientific Title of Study
|
A study to compare three insertion techniques for i-gel placement: standard, reverse and rotation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S K Singhal |
| Designation |
Senior Professor |
| Affiliation |
Pt. B. D. Sharma post graduate institute of medical sciences, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416391115 |
| Fax |
01126588872 |
| Email |
ssinghal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Singhal |
| Designation |
Senior Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology and Critical Care. Pt B D Sharma PGIMS
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416391115 |
| Fax |
|
| Email |
ssinghal12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S K Singhal |
| Designation |
Senior Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology and Critical Care. Pt B D Sharma PGIMS
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416391115 |
| Fax |
|
| Email |
ssinghal12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care PGIMS, Rohtak 124001, Haryana |
|
|
Primary Sponsor
|
| Name |
Anaesthesia and Critical Care Department PGIMS Rohtak |
| Address |
Pt BD Sharma Medical College and Hospital, Rohtak |
| 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 Rashmi |
Pt. B.D.Sharma PGIMS |
Department of anaesthesiology and critical care, PGIMS Rohtak
Rohtak
HARYANA |
9557283508
9557283508
rashi.singh65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Pt B D Sharma Post graduate institute of Medical Sciences, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
i-gel insertion |
i-gel is placed by rotation and reverse techniques of i-gel placement |
| Intervention |
i-gel insertion in general anaesthesia |
i-gel is placed by standard technique of placement of i-gel |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology (ASA) status I and II patients scheduled to undergo elective surgery in supine position |
|
| ExclusionCriteria |
| Details |
Mouth opening <2.5cm
Known difficult airway
Risk of aspiration
Body mass index >35 kg/m2
Acute sore throat |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i-gel is supraglottic airway device which can be insetted by either standard, rotation or reverse techniques. Various insertion characterstics like time of insertion, first attempt success rate are compared in these three techniques of insertion of i-gel. |
specific characterstics of i-gel insertion by three different techniques will be compared at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reverse and rotation techniques prevent tongue folding as compared to standard technique at the time of insertion |
insertion characterstics like first attempt success rate, oropharyngeal leak pressure, peak airway pressure, fibreoptic grades of placement are compared |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
15/12/2018 |
| 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="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Three techniques of insertion of i-gel will be compared in patients undergoing elective surgery in supine position |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In standard technique of i-gel placement i-gel will be inserted with its concave structure facing the mandible and advanced along hard palate, soft palate and posterior pharynx. In reverse technique i-gel will be inserted with its concavity facing toward hard palate and on reaching hard palate it will be rotated by 180 degree. In rotation technique i-gel will be inserted in mouth and rotated 90 degree counter clockwise around patients tongue, advanced until resistance is felt and re rotated clockwise to attain final position. And different insertion characterstics of all three techniques will be compared. |