CTRI Number |
CTRI/2023/12/060899 [Registered on: 28/12/2023] Trial Registered Prospectively |
Last Modified On: |
25/12/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Single Arm Study |
Public Title of Study
|
usage of ultrasound to determine size of paediatric endotracheal tube |
Scientific Title of Study
|
Ultrasonographic Measurement of Subglottic Diameter for Paediatric Endotracheal Tube Size Selection and its comparison with age based formulae: an observational prospective 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 |
dr charulata deshpande |
Designation |
Head of department,Professor,Guide |
Affiliation |
TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL |
Address |
Room 302,3rd floor,Department of Anesthesia,College building,TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL,mumbai central,mumbai
Mumbai (Suburban) MAHARASHTRA 400008 India |
Phone |
|
Fax |
|
Email |
desh56@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
dr jain roma |
Designation |
postgraduate |
Affiliation |
TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL |
Address |
Room 302,3rd floor,Department of Anestheisa,college building,TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL,mumbai central,mumbai
Mumbai (Suburban) MAHARASHTRA 400008 India |
Phone |
8097671274 |
Fax |
|
Email |
jain.roma6@gmail.com |
|
Details of Contact Person Public Query
|
Name |
dr jain roma |
Designation |
postgraduate |
Affiliation |
TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL |
Address |
Room 302,3rd floor,Department of Anestheisa,college building,TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL,mumbai central,mumbai
MAHARASHTRA 400008 India |
Phone |
8097671274 |
Fax |
|
Email |
jain.roma6@gmail.com |
|
Source of Monetary or Material Support
|
Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital,Dr. A. L. Nair Road, Mumbai - 400008 |
|
Primary Sponsor
|
Name |
dr charulata deshpande |
Address |
Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital,Dr. A. L. Nair Road, Mumbai - 400008 |
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 |
dr jain roma |
TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL |
Room 302,3rd floor,Department of Anestheisa,college building,TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL,mumbai central,mumbai-400008 Mumbai (Suburban) MAHARASHTRA |
8097671274
jain.roma6@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ECARP,TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
MEDICAL DEVICE(ULTRASOUND) |
Ultrasonographic Measurement of Subglottic Diameter of paediatric patients will be done only once,within 30 seconds of apnea time,after administering muscle relaxant. |
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
- Weight more than 10kg
- Patients requiring orotracheal intubation for anaesthesia
- Patients willing to give informed written consent
- American Society of Anaesthesiologists physical Status I and II patients
|
|
ExclusionCriteria |
Details |
- Patient refusal
- Emergency surgery
- Head and neck anatomical abnormality
- Restricted mouth opening
- Soft tissue swelling over neck
- Cervical spine injury, or abnormality
- Any other contraindication to intubation
- Patients requiring rapid sequence intubation.
- Uncooperative patients
- previous histories of tracheal and laryngeal pathologies, such as tracheostomy; previous surgery involving upper airway and any obvious scars
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
to assess the SGD ultrasongraphically and compare it with age based formulae;as a true reflection of the correct ETT size |
its a single point measurement, which be less than a minute after giving muscle relaxant |
|
Secondary Outcome
|
Outcome |
TimePoints |
-To assess the usefulness of US by reintubation attempts with different size of ETT due to unacceptable leak.
-To compare US predicted ETT size with age based formulae
|
Duration of the study will cease once the subglottic diameter is measured which may not be more than 15 minutes |
|
Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
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/ Phase 4 |
Date of First Enrollment (India)
|
05/01/2024 |
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="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
|
Choosing an appropriate sized Endotracheal Tube (ETT) is significant in paediatric patients. In neonatal period, the trachea resembles a funnel, tapered downward, maximally narrowed at the level of cricoid cartilage. However, in the later stages, it takes the shape of a cylinder. A large-sized ETT leads to trauma of the surrounding structures and subsequent airway edema, postextubation stridor, and subglottic stenosis in few. On the other hand, a smaller ETT would result in leakage, inadequate ventilation, increased resistance flow, and risk of aspiration, poor monitoring of end tidal gases. Both the cases demand an immediate tube change, complicating the situation as these patients having lower lung volume reserves tend to desaturate fast.A list of physical indices-based formulae such as age based, height based, Modified Cole’s formula for uncuffed tubes and Khine’s formula for cuffed tube, diameter of the distal digit of the little finger, have been used traditionally to determine the most suited size of the ETT. However, these assessments have failed to justify the purpose many a times leading to repeated laryngoscopy and tube change at time of intubation. Age based formulae are most commonly used and show a variable success rate ranging from 47% to 77%. During recent years, several studies explored the possibility of utilising ultrasound guided ETT size selection in paediatric age group. The advantages of using US for measuring airway diameters are the following: it is a minimally invasive technique, is easily available at the bedside, and has proven value for assessing airway anatomy. In addition, it can also assess the airway for any other abnormality before attempting intubation. All the previous studies were performed in a western population. It is well known that ultrasound measurements vary significantly depending on the ethnicity of the child, hence the need for this study. With the increase in availability and acquaintance of the modern ultrasound devices to the anaesthesiologists, the complication rate is expected to see a downward trend with a promise toward better outcome. |