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CTRI Number  CTRI/2024/08/072727 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Endotracheal tube depth confirmation using ultrasound in adults 
Scientific Title of Study   Study of correct endotracheal tube insertion depth using ultrasound in adults undergoing elective surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amulya S P 
Designation  POST GRADUATE 
Affiliation  ESIC Medical college and PGIMSR 
Address  Room 1 Department of anaesthesiology,2nd floor

Bangalore
KARNATAKA
560010
India 
Phone  9036805907  
Fax    
Email  Amulyasp1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Dhummansure 
Designation  Professor and HOD  
Affiliation  ESIC Medical college and PGIMSR 
Address  2nd Floor OT Complex, Department of Anaesthesiology, ESIC MC and PGIMSR, Rajajinagar

Bangalore
KARNATAKA
560010
India 
Phone  9980050864  
Fax    
Email  10drdeepak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Dhummansure 
Designation  Professor and HOD dept of anaesthesia 
Affiliation  ESIC Medical college and PGIMSR 
Address  2nd Floor OT Complex, Department of Anaesthesiology, ESIC MC and PGIMSR, Rajajinagar

Bangalore
KARNATAKA
560010
India 
Phone  9980050864  
Fax    
Email  10drdeepak@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical college and PGIMSR Rajajinagar,Bangalore-560010 
 
Primary Sponsor  
Name  Dr Amulya S P 
Address  ESIC Medical college and PGIMSR,Rajajinagar,Bangalore-560010 
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
ESIC Medical college and PGIMSR  ESIC medical college and PGIMSR,Rajajinagar,Bangalore,560010 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AMULYA S P  ESIC Medical college and PGIMSR  Department of anaesthesiology,2nd floor,room no 1,Rajajinagar,Bangalore,560010
Bangalore
KARNATAKA 		 9036805907

amulyasp1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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 
Comparator Agent  Bilateral air entry confirmation  Confirming endotracheal tube placement with bilateral air entry and etco2 method in adults undergoing elective surgery 
Intervention  Measurement of vocal cord to endotracheal cuff using ultrasound  Measurement of vocal cord to endotracheal cuff using ultrasound and adjusting the appropriate distance 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient willing to give informed consent
ASA GRADE I and II
Elective surgical procedures requiring general anesthesia 
 
ExclusionCriteria 
Details  Difficult airway
Patient with cervical trauma, midline neck swelling
Pregnant and breast feeding females
Patient with non-visualization of vocal cords on ultrasound 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.depth of insertion of endotracheal tube between 2-4cm  immediately 
 
Secondary Outcome  
Outcome  TimePoints 
1Variation in depth of insertion  Immediately 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   30/08/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  through publication

  6. For how long will this data be available start date provided 08-08-2024 and end date provided 07-10-2044?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary    Correct endotracheal tube insertion depth using ultrasound to prevent endobronchial or endotracheal placement and for confirmation of correct depth of endotracheal tube in adults undergoing elective surgery under general anaesthesia 
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