FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034600 [Registered on: 05/07/2021] Trial Registered Prospectively
Last Modified On: 30/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Prediction of Endotracheal Tube Size in Children by Comparing Ultrasound Based Technique versus Age Based Formula. 
Scientific Title of Study   Comparision between Ultrasound Based Technique with Age Based Formula in Prediction of Appropriate Endotracheal Tube Size in Children. "One Year Hospital Based Randomised Control Trial" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  YEKKALDEVI MANOGNYA 
Designation  POST GRADUATE 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE,KLE CAMPUS ,NEHRU NAGAR,BELAGAVI.
DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE,KLE CAMPUS ,NEHRU NAGAR,BELAGAVI.
Belgaum
KARNATAKA
590010
India 
Phone  9848092044  
Fax    
Email  manognyahy94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RAJESH S MANE 
Designation  PROFESSOR AND HEAD OF DEPARTMENT 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE,KLE CAMPUS ,NEHRU NAGAR,BELAGAVI.
DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE,KLE CAMPUS ,NEHRU NAGAR,BELAGAVI.
Belgaum
KARNATAKA
590010
India 
Phone  9844131062  
Fax    
Email  drrajeshmane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  YEKKALDEVI MANOGNYA 
Designation  POST GRADUATE 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE,KLE CAMPUS ,NEHRU NAGAR,BELAGAVI.

Belgaum
KARNATAKA
590010
India 
Phone  9848092044  
Fax    
Email  manognyahy94@gmail.com  
 
Source of Monetary or Material Support  
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER,BELAGAVI,KARNATAKA 
 
Primary Sponsor  
Name  YEKKALDEVI MANOGNYA 
Address  DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE,BELAGAVI,KARNATAKA 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Yekkaldevi Manognya  Department of Anaesthesiology  IInd Floor OT Complex, Jawaharlal Nehru Medical College, KLE Campus, Belagavi
Belgaum
KARNATAKA 
9848092044

manognyahy94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AGE BASED TECHNIQUE  Patient intubated with an endotracheal tube size as determined by the age based formula 
Intervention  ULTRASOUND BASED TECHNIQUE   Patient intubated with an Endotracheal tube of the size as determined by ultrasonographic assessment of subglottic diameter by sonosite M TURBO linear probe of frequency 7-15MHZ 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Consent provided by parents and guardians
2.Children aged 1-8 years of age
3.ASA physical status I and II
4.Patients undergoing elective surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  1.Patients whose parents are not consenting for the study
2.Patients having upper respiratory tract infection, tracheal and laryngeal pathology
3.Patients undergoing emergency surgeries
4.Patients with airway difficulties
5.Previous history of child requiring an exceptionally large or small size tube 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the Efficiency of ultrasound with age-based formula to estimate the correct size Endotracheal tube in paediatric age  2 minutes of induction 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare number of endotracheal tube changes in two groups  0mins 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   12/07/2021 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Methodology:

After obtaining the approval of ethical committee and written informed consent, a total of 50 paediatric patients undergoing surgery under general anesthesia with endotracheal intubation will be included in the study.

After having met inclusion and exclusion criteria, and having obtained informed consent, patients will be randomized based on computer generated randomization table into one of the two groups of 25 each

 

Group A: (N=25)

Intubated with an Endotracheal tube of the size as determined by the age based formula.

 

Group B: (N=25)

Intubated with an Endotracheal tube of the size as determined by ultrasonographic assessment of subglottic diameter. By sonosite M TURBO linear probe of frequency 7-15MHz.

 

A thorough pre-anesthetic evaluation will be done on the day   before surgery with necessary investigations like complete blood count (CBC), chest X-ray, mini renal profile & liver function test will be done if required

 

Child will be kept NBM for at least 6 hours prior to surgery.

On the day of surgery, in the recovery room after confirming the NBM status and consent will be ascertained. Child will be given Inj.Glycopyrrolate (0.005mg/kg) and Inj. Ketamine(5mg/kg) IM and then shifted to operation theatre.

 

Inside the operation theatre standard monitoring devices like ECG, pulse oximeter and NIBP will be connected.

Intravenous access will be secured using 22G or 24G IV cannula and IV infusion will be started.

       

Group-A: ETT tube size will be estimated by using age based formula 

Age/3 + 3.5

In children < 6years -

In children > 6years -  Age/4 + 4.5

Group-B:

ETT tube size will be estimated by measuring the subglottic diameter using high resolution B ultrasonography.

 

·       Child in supine position with head at neutral position the probe of ultrasonography will be placed in midline.

·       True vocal cords will be localized which can be seen as a pair of hyperechoic linears structure which move along with respiration and swallowing.

·       Then the probe will be moved caudally to visualize the cricoid arch to avoid confusion between the cricoid cartilage and tracheal ring.

·       The measurement of tracheal diameter will be taken as a transverse air column diameter done at cephalic half of the cricoid cartilage which is narrower than the caudal part of cricoid cartilage.

·       Patient will be pre-oxygenated with 100% oxygen for 3 minutes and then premedicated with Inj.Midaz(0.05mg/kg) and Fentanyl (1-2mcg/kg) and induced with Inj.ketamine(1-2mg/kg) and Inj. Scoline(2mg/kg) will be given to achieve skeletal muscle paralysis to facilitate endotracheal intubation.

·       Uncuffed endotracheal tubes will be used.

·       Endo tracheal tube intubation will be done.

The following parameters will be used to assess whether the selected ETT is of an appropriate size :

  • ·       ETT passing smoothly through the glottis
  •      No audible leak occurs at 10 to 20 cms of H2O.
  •        A square wave capnography on ventilation.



 

GROUP A

GROUP B

“Best fit” < Predicted

“Best fit” = Predicted

“Best fit > Predicted

“Best fit” < Predicted

“Best fit” = Predicted

“Best fit” > Predicted

ESTIMATION OF ENDOTRACHEAL TUBE SIZE BY USING ULTRASONOGRAPHY

 

 

 

 

 

 

 

ESTIMATION OF ENDOTRACHEAL TUBE SIZE BY USING AGE BASED FORMULA

 

 

 

 

 

 




















Number of tube changes for intubation


Age group (years)

1

2

3

1 – 2

 

 

 

2 -3

 

 

 

3 -4

 

 

 

4 -5

 

 

 

5 -6

 

 

 

6- 7

 

 

 

7 -8

 

 

 

 

 
Close