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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  
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 
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  
Status 
Not Applicable 
 
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.

 

 

 

 

 

 
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