| CTRI Number |
CTRI/2021/02/031494 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
13/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of weight based to thenar eminence size based insertion of igel in paediatric patients. |
|
Scientific Title of Study
|
The comparison of standard weight based and thenar eminence dimension based selection of I-gel in paediatric patients- A randomized controlled study. |
| Trial Acronym |
CSTSIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Latha V Petkar |
| Designation |
Postgraduate in Anaesthesiology |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Kims, hubli
Department of Anaesthesiology,
KIMS, Hubli
Davanagere
KARNATAKA
577006
India |
| Phone |
09380822826 |
| Fax |
|
| Email |
liyaaa2700@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Sachidananda |
| Designation |
Associate professor |
| Affiliation |
KIMS HUBLI KARNATAKA |
| Address |
Dept of Anaesthesiology
KIMS
Hubli
Karnataka
Dept of Anaesthesiology
KIMS
HUBLI
KARNATAKA
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Sachidananda |
| Designation |
Associate professor |
| Affiliation |
KIMS HUBLI KARNATAKA |
| Address |
Dept of Anaesthesiology
KIMS
Hubli
Karnataka
Dept of Anaesthesiology
KIMS
HUBLI
KARNATAKA
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
KIMS |
| Address |
KIMS, HUBLI, KARNATAKA |
| 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 |
| Latha |
KIMS |
Room no.206, Anaesthesiology department, KIMS, HUBLI KARNATAKA.
Dharwad
KARNATAKA |
9380822826
liyaaa2700@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka institute of medical council |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Thenar eminence size based group and
Weight based group |
In thenar eminence size based group, I-gel will be based on the thenar eminence size of paediatric patients undergoing GA.
In standard weight based group, I-gel will be selected based method in paediatric patients undergoing general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and grade 2.
Patients belonging to either sex.
Scheduled to undergo various short surgical procedures under General anaesthesia using I-gel.
Patients giving informed written consent .
|
|
| ExclusionCriteria |
| Details |
Patients with suspected airway difficulty( mallampati grade 3 and grade 4)
Significant cardiovascular pulmonary and liver diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Alternate method of selection of i-gel, which can be applied in cases where the weight of the patient is not known and where the weight is not a reliable factor and can be applied in emergency cases.
|
The percentage of successful insertion of i-gel .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of insertion and adverse events in thenar eminence size based selection of i-gel in terms of time taken for insertion of i-gel or adverse events associated with insertion of i-gel like coughing, gagging, etc. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
Supraglottic airway devices are integral part of general anaesthesia and various anatomical landmarks are being studied as a tool for selection of appropriate size of I-gel. Weight based selection of i-gel may not be suitable for underweight or overweight children and in immobilized or unconscious patients. Hence, first attempt success rate of insertion of igel will be compared among two groups - thenar eminence based and standard weight based among paediatric patients. |