| CTRI Number |
CTRI/2020/11/029110 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
13/11/2020 |
| 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
|
Determining size of supralaryngeal device I gel by body weight method or measurement of thenar eminence dimension in paediatric patients |
|
Scientific Title of Study
|
Comparative study to determine i-gel size by recommended body weight method and measurement of thenar eminence dimension in paediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sivashankari B |
| Designation |
Post graduate resident |
| Affiliation |
B.j medical college,civil hospital, ahmedabad |
| Address |
B.j medical college,
Asarwa,Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
8667479075 |
| Fax |
|
| Email |
shankarisiva24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
B.j medical college,civil hospital, ahmedabad |
| Address |
b.j medical college,
Civil hospital,
Asarwa,
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
B.j medical college,civil hospital, ahmedabad |
| Address |
b.j medical college,
Civil hospital,
Asarwa,
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and family welfare department, Sachivalay, Gandhinagar |
| 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 |
| Sivashankari b |
Pediatric operation theater |
3rd floor, F7, pediatric operation theater, civil hospital, Asarwa, ahmedabad
Ahmadabad
GUJARAT |
8667479075
shankarisiva24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee , B.J medical college and civil hospital,ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
determination of I gel size by recommended body weight method or measurement of thenar eminence dimensions |
In paediatric patients preoperatively size of I gel determinataion by determination of I gel size by recommended body weight method or measurement of thenar eminence dimensions |
| Intervention |
Insertion of proper size I gel |
After determination of I gel size by recommended body weight method or measurement of thenar eminence dimensions, proper size I gel insertion for continuation of general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Weight 5 to 25 kg
Elective surgeries
Surgeries last less than 2hours
ASA classification I, II, III
|
|
| ExclusionCriteria |
| Details |
Any morphological changes of hand
Patient had previous hand surgeries
ASA classification IV, V
Patient and parent refusal
Children with anticipated difficult airway
Patient needed rapid sequence induction
History of upper respiratory tract infection in past 2 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proper Placement of device and Adequacy of Ventilation |
Time for the initiation of insertion of i gel and the adequacy of ventilation achieved |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts, Leak fraction LF, Total insertion time and Incidence of complications |
starting of I gel insertion to 20 minutes after adequate ventilation with I gel |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable at present |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I gel is most widely used second generation supraglottic device. In pediatric day care surgery, I gel can be used safely and effectively in anesthetized children. Four sizes (1, 1.5, 2 and 2.5) of pediatric I gel is available. The manufacturer recommends the size of I gel to be used in children should be based on actual body weight but this method has several limitations. One important limitation is size of oropharyngeal cavity which is related to height and age rather than weight of child. All these factors may lead to inappropriate size selection, which may result in larger sized I gel causing trauma/injury to the airway and smaller size causing obstruction or insufficient ventilation. To overcome these concerns, some alternatives have been tried by few researchers. One of them is association between thenar eminence and I gel dimension in paediatric patients. Considering this we therefore would like to know whether the thenar eminence dimension based method can be used for I gel size selection in pediatric surgical patients. |