| CTRI Number |
CTRI/2024/07/069882 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical study comparing different methods to estimate the size of endotracheal tube in children |
|
Scientific Title of Study
|
Clinical study comparing ultrasound, age and height based estimation of endotracheal tube size in pediatric patients |
| 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 Abhishek R |
| Designation |
Associate Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar,Meppadi(PO),Wayanad,
Kerala, India
Wayanad
KERALA
673577
India |
| Phone |
07795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek R |
| Designation |
Associate Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO),Wayanad,Kerala, India.
Wayanad
KERALA
673577
India |
| Phone |
07795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek R |
| Designation |
Associate Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Naseera Nagar,Meppadi (PO),Wayanad, Kerala, India
Wayanad
KERALA
673577
India |
| Phone |
07795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Moopens Medical College, Naseera Nagar, Meppadi (PO),Wayanad, Kerala, India.
PIN-673577 |
|
|
Primary Sponsor
|
| Name |
Dr Moopens Medical College |
| Address |
Dr Moopens Medical College, Naseera Nagar, Meppadi (PO),Wayanad, Kerala, India. PIN-673577 |
| Type of Sponsor |
Private 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 |
| Dr Abhishek R |
Dr Moopens Medical College |
Department of Anaesthesiology, 7th floor OT complex, Naseera Nagar,Meppadi (P.O),Wayanad,
Kerala, India. PIN- 673577
Wayanad
KERALA |
7795450038
dr.abhishek.rajanaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Moopens Medical College |
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 |
Group A |
Age based formula to estimate the size of endotracheal tube will be used in this group with the formula-Age/3+3.75 . This will be measured once the Allocated patient is shifted to the operation theater holding area and his Age will be used to derive the size of endotracheal tube |
| Comparator Agent |
Group H |
Height based formula to estimate the size of endotracheal tube will be used in this group with the formula- 4+0.1x Height in centimeters. This will be measured once the Allocated patient is shifted to the operation theater holding area and his height in centimeters will be measured and used to derive the size of endotracheal tube. |
| Intervention |
Group U |
Ultrasound scan of front of the neck is done using a linear ultrasound probe which is placed on front of the neck to scan the larynx, the scan is non invasive and painless. This will be measured once the Allocated patient is shifted to the operation theater holding area. This scan will take a duration of 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
78 patients aged 5 years to 14 years who are healthy with no co morbidities undergoing elective surgeries under general anesthesia are included in the study |
|
| ExclusionCriteria |
| Details |
Patients with difficult airway,
patients with history of delayed growth milestones,
patients with respiratory or cardiac diseases,
presence of any neck mass or swelling |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the most efficient way to estimate the size of endotracheal tube in pediatric patients by comparing ultrasound scan, age based formula or height based formula |
Leak test will be performed at baseline and every 5 minutes until the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measure ease of insertion using 3 point scale of easy, difficult & no intubation |
at baseline & every 5 minutes until the end of surgery & every hour after that until 24 hours |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| Date of Study Completion (India) |
05/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 primary objective of the study is to find out the accurate method of estimating the size of Endotracheal tube which will be used for intubations for surgeries. In current practice endotracheal tube size is estimated using age based formula and height based formula but, in our study we are doing an ultrasound scan of the front of the neck to estimate the appropriate size of endotracheal tube to be used. Hence, in this study, a total of 78 healthy patients aged 5years to 14years undergoing elective surgeries under general anesthesia will be recruited,
The total sample size will be divided into 3 groups of 26 each. Group U will undergo an ultrasound scan of the front of the neck to estimate the size of endotracheal tube. Group A will use age based formula to calculate the appropriate size of the endotracheal tube and Group H will use patients height to estimate the size of the endotracheal tube. This study is relevant because choosing the wrong size of endotracheal tube can cause multiple complications related to the larynx and the trachea. Also, the Age and Height based formulas were designed for western children and the same measurements are not accurate for our pediatric population. Hence In this study we are comparing a non invasive, painless, novel modern technique using ultrasound scan to estimate the size of endotracheal tube in pediatric patients undergoing elective surgeries. The primary Objective of this study is to find out which method is more accurate in estimating endotracheal tube size by performing a ’leak test’ on the ventilator to see if the size is appropriate. |