FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057883 [Registered on: 20/09/2023] Trial Registered Prospectively
Last Modified On: 18/09/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   Comparison of ultrasound and chest X ray for localization of tip of central venous catheter in patients admitted in intensive care unit. 
Scientific Title of Study   Comparison of point of care ultrasound and chest X-ray for localization of tip of central venous catheter in patients admitted in intensive care unit. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahil singh 
Designation  Associate Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Room number 413 BL Taneja block Maulana Azad medical college Bahadur shah Zafar Marg
Intensive Care Unit, fourth floor, Lok Nayak Hospital New Delhi 110002room
Central
DELHI
110002
India 
Phone  09810719025  
Fax    
Email  drrahilsingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rahil singh 
Designation  Associate Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Room number 413 BL Taneja block Maulana Azad medical college Bahadur shah Zafar Marg
Intensive Care Unit, fourth floor, Lok Nayak Hospital New Delhi 110002room
Central
DELHI
110002
India 
Phone  09810719025  
Fax    
Email  drrahilsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rahil singh 
Designation  Associate Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Room number 413 BL Taneja block Maulana Azad medical college Bahadur shah Zafar Marg
Intensive Care Unit, fourth floor, Lok Nayak Hospital New Delhi 110002room
Central
DELHI
110002
India 
Phone  09810719025  
Fax    
Email  drrahilsingh@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital 
 
Primary Sponsor  
Name  Lok Nayak hospital 
Address  Room No. 413 B L Taneja Block Maulana Azad Medical College Bahadur shah Zafar Marg Delhi 
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 
Rahil Singh  Lok Nayak Hospital  Intensive Care Unit, fourth floor, Lok Nayak Hospital New Delhi 110002
Central
DELHI 		 09810719025

drrahilsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College and associated hospitals.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J703||Chronic drug-induced interstitiallung disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Adult patients admitted in intensive care unit requiring central venous line insertion through subclavian or internal jugular vein. 
 
ExclusionCriteria 
Details  • Age < 18 years
• Coagulopathy (INR > 1.5)
• Pregnancy
• Inability to obtain proper window on transthoracic echocardiography
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and specificity of transthoracic echocardiography (TTE) subcostal view in detecting tip of Central Venous Catheter.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Sensitivity and specificity of TTE apical 4 chamber view in detecting tip of CVC.
2. Sensitivity and specificity of Chest X Ray in detecting tip of Central Venous Catheter.
 		 5 min 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   30/09/2023 
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 Yet Recruiting 
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

  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) -  by sending request to drrahilsingh@gmail.com

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 30-09-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Correct position of central venous catheter is important to avoid life threatening mechanical complications such as cardiac tamponade,cardiac perforation, dysrhythmia and for proper interpretation of central venous pressure and intravascular volume. Real time ultrasound guidance of central venous catheter insertion improves the safety and efficacy of its placement, which has been extensively reported. Ultrasonogrphy confirms correct placement and if found to be malpositioned , it can be repositioned at the same sitting. Hence saves time, cost and radiation exposure to the patient. 
In this study we aim to evaluate the efficacy of contrast enhanced ultrasonography using apical four chamber and subcostal view for detection of correct placement of the central venous catheter tip and compare it with chest Xray post central venous catheter insertion.
 
Close