| CTRI Number |
CTRI/2025/10/096612 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| 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
|
Tongue width versus weight based method for size determination of laryngeal mask airway in children |
|
Scientific Title of Study
|
Tongue width versus weight based method for size determination of laryngeal mask airway in children
Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sidharth D Nair |
| Designation |
Post graduate resident |
| Affiliation |
MOSC medical College |
| Address |
Department of Anaesthesiology and Critical Care
MOSC medical college
Kolenchery PO
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
7760736131 |
| Fax |
|
| Email |
dsidharthnair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sara Vergis |
| Designation |
HOD and Professor |
| Affiliation |
MOSC medical College |
| Address |
Department of Critical Care
MOSC medical college
Kolenchery PO
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
9446596066 |
| Fax |
|
| Email |
skorula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sara Vergis |
| Designation |
HOD and Professor |
| Affiliation |
MOSC medical College |
| Address |
Department of Critical Care
MOSC medical college
Kolenchery PO
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
9446596066 |
| Fax |
|
| Email |
skorula@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC medical college
Kolenchery PO
Ernakulam
682311 |
|
|
Primary Sponsor
|
| Name |
Dr Sidharth D Nair |
| Address |
Department of anaesthesiology
MOSC medical college
Kolenchery PO
Ernakulam
682311 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sidharth D Nair |
MOSC medical college |
Department of Anaesthesiology
Ernakulam
KERALA |
7760736131
dsidharthnair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commiittee |
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 |
| Comparator Agent |
Size of LMA supreme based on weight of child |
Patients requiring LMA supreme will be allotted the laryngeal mask airway based on the weight of the child for a duration till procedure is completed |
| Intervention |
Size of LMA supreme based on width of tongue |
Patients requiring LMA supreme will be allotted the laryngeal mask airway based on the scale after measuring width of the tongue for a duration till procedure is completed |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between the ages 3 to 12 years of either gender for surgery under general anaesthesia with LMA
ASA category 1 and 2
Duration of surgery less than 2 hours
Adequate nil per oral duration |
|
| ExclusionCriteria |
| Details |
High risk of regurgitation
Anticipated difficult airway
Weight more than 50 kilograms
Contraindication to insertion of LMA
Known allergies to drugs used in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To determine the size of LMA supreme by using tongue width vs weight based method in children
2 To determine the ease of insertion of LMA chosen by using tongue width vs weight based method in children |
Pre operatively and after induction till 15 minutes
After extubation till 30 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess the hemodynamic response to insertion of LMA supreme
2 To assess post operative complication of insertion of LMA supreme |
Pre operatively till 15 minutes after intubation
After extubating for 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to assess the difference in the size determined of a LMA and its ease of insertion by the weight based technique and tongue width based technique and see if the latter can be used as a tool of assessment of the same. Children within the age group of 3 to 12 years are included undergoing surgery under general anaesthesia lasting less than 2 hours and in whom there are no contraindications of LMA insertion or receiving GA Patients will be evaluated prior to the procedure and the LMA provided is based depending on which group the patient is in. Children in group A shall receive LMA based on tongue width and those in group B on weight based. Once inside the operating room the patient is induced and LMA is inserted We assess the time taken insert, number of attempts taken, change in size of LMA or ETT, adequacy of ventilation, adequacy of oxygenation and in the peri operative period look for hypoxemia, laryngospasm, bronchospasm, displacement of LMA and blood on cuff on removal. After extubation the child will be monitored for 30 minutes for any new complication. The above mentioned parameters will be noted all while maintaining safety of the patient. |