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CTRI Number  CTRI/2023/08/055927 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Prospective observational study for estimating the point of fixation of endotracheal tube using ultrasound and clinical parameters (5-point auscultation) in Indian population  
Scientific Title of Study   Prospective observational study for estimating the optimal Depth of insertion of endotracheal tube in orotracheal Intubation using ultrasound and clinical parameters (5-Point auscultation) in Indian population at tertiary care Hospital 
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 Shrikanta Oak 
Designation  Professor  
Affiliation  Seth GSMC and KEM Hospital  
Address  Department of Anaesthesiology Seth GSMC and KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9324134023  
Fax    
Email  Shrikanta_oak@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shrikanta Oak 
Designation  Professor  
Affiliation  Seth GSMC and KEM Hospital  
Address  Department of Anaesthesiology Seth GSMC and KEM Hospital Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9324134023  
Fax    
Email  Shrikanta_oak@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharayu Parode  
Designation  Junior Resident  
Affiliation  Seth GSMC and KEM Hospital  
Address  Department of Anaesthesiology Seth GSMC and KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8605265390  
Fax    
Email  Sharayup96@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Seth GSMC and KEM Hospital Parel Mumbai 
 
Primary Sponsor  
Name  Seth GSMC and KEM Hospital  
Address  Department of Anaesthesiology Seth GSMC and KEM Hospital Parel Mumbai 
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 Shrikanta Oak  Seth GSMC and KEM Hospital  Neurosurgery theatre Department of Neurosurgery, Seth GSMC and KEM Hospital Parel Mumbai
Mumbai
MAHARASHTRA 
9324134023

shrikanta_oak@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-II Seth GSMC and KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female in age group of 18 to 65years.
2. Planned for elective surgery under general anaesthesia requiring orotracheal intubation. 
 
ExclusionCriteria 
Details  1. Patient not willing for study.
2. Abnormal airways or Neck anatomy (Burns or Post
burn contractures).
3. Restrictive neck movement.
4. History of neck tumor and Cervical surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the optimal depth of insertion of Endotracheal tube using Ultrasound & Clinical parameters
 
After induction and intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To find the percentage of subjects requiring change in depth of insertion with use of USG  After completion of study 
To find the optimal depth of insertion of endotracheal tube in relation to height & neck length in an individual in Indian population  After completion of study 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/08/2023 
Date of Study Completion (India) 31/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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
Modification(s)  

Endotracheal intubation is routine procedure in general anaesthesia to maintain the oxygenation and ventilation. Appropriate depth of insertion of endotracheal intubation confirms the safety of patient from endobronchial intubation leading to single lung ventilation, atelectasis and too shallow placed endobronchial cuff will result in vocal cord injury. Among the various techniques such as X-Rays, fiber optic bronchoscopy, ultrasound etc. used to determine the correct depth of endotracheal tube insertion Ultrasound is noninvasive, safe and fairly accurate method.

Saline inflated cuff is visualized using ultrasound to confirm the correct endotracheal tube placement and depth of insertion. As length of trachea and distance from teeth to vocal cords varies in individuals a fixed depth or fixed mark on ETT may be inadequate and will vary with height and neck length. As suggested in some studies the proximal part of cuff should be 1.5 cm to 2.5 cm from vocal cords and at Tracheal ring T2 to T4 the ultrasound will be easy guide to determine the endotracheal tube cuff position.

Ultrasound can be used to determine the correct depth of ET cuff in Indian adult population and its relation to height, neck length.

Anthropometry of Individuals i.e. (Height and Neck Length) affect the optimal depth of insertion of Endotracheal tube.

The primary objective of this study is to determine the depth of insertion of Endotracheal tube using Ultrasound and Clinical parameters. Secondary is to find the correlation between the depth of insertion of ETT with height and neck length in Indian population.

 
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