| CTRI Number |
CTRI/2024/04/065299 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two ways to pick the right size breathing tube for children during surgery - Using a formula based on age or ultrasound |
|
Scientific Title of Study
|
Age based motoyama formula versus ultrasound guided subglottic diameter in predicting endotracheal tube size in pediatric population - A Prospective Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajasekar MG |
| Designation |
1st year Post Graduate resident |
| Affiliation |
Apollo KH Hospital |
| Address |
Apollo KH Hospital
Department of Anaesthesiology
MELVISHARAM
RANIPET DISTRICT
Vellore
TAMIL NADU
632509
India |
| Phone |
7598404362 |
| Fax |
|
| Email |
krishrajasekar54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jalakandan B |
| Designation |
Head of department |
| Affiliation |
Apollo KH Hospital |
| Address |
Apollo KH Hospital
Department of Anaesthesiology
MELVISHARAM
RANIPET DISTRICT
Vellore
TAMIL NADU
632509
India |
| Phone |
9994976064 |
| Fax |
|
| Email |
dr_jalakandan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dinakaran K |
| Designation |
Senior consultant |
| Affiliation |
Apollo KH Hospital |
| Address |
Apollo KH Hospital
Department of Anaesthesiology
MELVISHARAM
RANIPET DISTRICT
Vellore
TAMIL NADU
632509
India |
| Phone |
9789133630 |
| Fax |
|
| Email |
drkaran01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo KH hospital,Ranipet Vellore Bye Pass Road,Melvisharam 632 509, Ranipet District, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
RAJASEKAR MG |
| Address |
APOLLO KH HOSPITAL
Department of Anaesthesiology
MELVISHARAM
RANIPET DISTRICT |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| APOLLO KH HOSPITAL |
MELVISHARAM
RANIPET DISTRICT |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAJASEKAR MG |
Apollo KH Hospital |
Operation theatre complex,
Department of anaesthesiology
Ranipet Vellore Bye Pass Road,Melvisharam 632 509, Ranipet District, Tamil Nadu, india.
Ranipet
Vellore
TAMIL NADU |
7598404362
krishrajasekar54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KHIHS Ethics committee clearance |
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 |
Predicting endotracheal tube size by age based motoyama formula |
After the pre-anesthetic assessment, patients are randomized into two groups for intubation.For group B patient after the mask ventilation endotracheal tube size will be derived by age based motoyama formula and patients will be intubated with this formula.Both groups undergo standard anesthesia induction and maintenance, with endotracheal tube leak tests performed to ensure correct sizing.
|
| Intervention |
ULTRASOUND GUIDED SUBGLOTTIC DIAMETER MEASUREMENT |
After the pre-anesthetic assessment, patients are randomized into two groups for intubation.For group A patients during the mask ventilation ,the subglottic diameter will be assessed with high resolution B mode ultrasonography with linear probe having frequencies 6 to 13 MHz on the midline of the anterior neck.The transverse air column diameter measured at the cephalic half of the cricoid cartilage will be taken as subglottic diameter.The measured subglottic diameter corresponds to the ETT with similar outer diameter.But to avoid injury to the airway we will choose Endotracheal tube size 0.5 mm less than the measured tracheal diameter and the patient will be intubated with USG derived endotracheal tube size.Both groups undergo standard anesthesia induction and maintenance, with endotracheal tube leak tests performed to ensure correct sizing. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients parent/guardian willing to give informed written consent
2. American society of Anaesthesiologist (ASA) class 1,class 2
3. Age group 5-12 years
4. Both sexes
5. BMI [ 5th - 85th percentiles]
6. Patients undergoing various elective surgery under general anaesthesia and requiring endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1.Preexisting laryngeal or tracheal pathology
2. Patients with facial abnormalities
3.Anticipated difficult airway
4.Patients having respiratory tract infections
5.Emergency surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Leak Test |
Immediately after the intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Airway pressure
2.Number of times the child was intubated
3.Post op complication
|
1.After 5 minutes of succesful insertion of endotracheal tube
2.During the intubation
3.Post operatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| 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="5"
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
|
This prospective comparative study, led by Dr. MG Rajasekar, aims to evaluate the effectiveness of age-based Motoyama formula versus ultrasound-guided subglottic diameter in predicting the correct endotracheal tube (ETT) size in the pediatric population. The primary objective involves identifying appropriate ETT size by the leak test, with secondary objectives including assessing airway pressure, intubation attempts, and postoperative complications.The study plans to enroll 70 pediatric patients.After the pre-anesthetic assessment, patients are randomized into two groups for intubation. Group B uses the Motoyama age-based formula for endotracheal tube (ETT) size calculation, while Group A employs high-resolution ultrasonography to assess subglottic diameter. Both groups undergo standard anesthesia induction and maintenance, with ETT leak tests performed to ensure correct sizing. Airway pressure is monitored, and neuromuscular blockade is managed. Post-surgery, complications such as cough, blood staining, and stridor incidence are observed.Total number of clinically fit and unfit will be calculated by the leak test and number of times ETT changed will be documented.Statistical analysis will employ IBM SPSS version 20.0, with significance set at p-value < 0.05. The study is scheduled from April 2024 to September 2025 at Apollo KH Hospital, Melvisharam. |