| CTRI Number |
CTRI/2024/07/070535 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can wrist bone size in children measured using ultrasound predict the right size breathing tube for children. |
|
Scientific Title of Study
|
Evaluation of distal radius epiphyseal diameter as a predictor of endotracheal tube size in paediatric 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 Labeeba Latheef K K |
| Designation |
Postgraduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main
OT Complex, VMMC & Safdarjung Hospital, Ansari Nagar(in front of
AIIMS)
South DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8547953717 |
| Fax |
|
| Email |
lamby770@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main
OT Complex, VMMC & Safdarjung Hospital, Ansari Nagar(in front of
AIIMS)
South DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Labeeba Latheef K K |
| Designation |
Postgraduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main
OT Complex, VMMC & Safdarjung Hospital, Ansari Nagar(in front of
AIIMS)
South DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8547953717 |
| Fax |
|
| Email |
lamby770@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC &
Safdarjung Hospital, Ansari Nagar(in front of AIIMS), New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC & Safdarjung Hospital, Ansari Nagar(in front of AIIMS), New Delhi - 110029 |
| Type of Sponsor |
Government 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 |
| Labeeba Latheef K K |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and intensive care
New Delhi
DELHI |
8547953717
lamby770@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung Hospital Institutional ethics committee |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2-7 years, having American Society of Anaesthesiologist physical status I and II, undergoing elective surgery under general anaesthesia requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Children with:
1.Known laryngeal or tracheal pathology
2.Known musculoskeletal disorders
3.Congenital developmental disorders
Deformity of the hand and extremities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find correlation of ultrasonographic measurement of distal radius epiphysis diameter with appropriate endotracheal tube size in paediatric age group. |
5 minutes after intubating the patient. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find correlation, of
1)ultrasonographic measurement of epiphyseal transverse diameter of the 3rd and 5th proximal phalanx with endotracheal tube size.
2)circumference of the wrist with endotracheal tube size.
3)circumference of the finger at the level of 3rd and the 5th proximal phalanx with endotracheal tube size. |
10 minutes after intubating the patient. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/07/2024 |
| 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="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
|
My study is aimed to evaluate the role of distal radius epiphysis diameter as a predictor of appropriate endotracheal tube size in paediatric patients.All children will undergo preanaesthetic checkup and cases included in study according to inclusion and exclusion criteria.Premedication will be given using nasal dexmedetomidine.Baseline parameters will be recorded after shifting them to operation theatre.Inhalational or intravenous induction of general anaesthesia will be carried out.Intravenous vecuronium will be used to facilitate muscle relaxation.After three minutes,the first trial of intubation will be carried out using an uncuffed endotracheal tube which will be selected according to the age based formula.And then monitor the air leakage over the larynx using sthethoscope.If a leak occur at an airway pressure of less than 10cm H2O when the lungs are inflated or no audible leak at airway pressure more than 25cm H20 change ETT 0.5mm ID bigger or smaller respectively.Then the childs hand will be examined using a portable ultrasound device.The epiphyseal transverse diameter of the distal radius,the 3rd proximal phalanx,and the 5th proximal phalanx will be estimated.Circumferences of the wrist and the finger at the level of the 3rd and the 5th proximal phalanx will also be measured. |