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
|
|
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
|
|
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 | | | | |