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CTRI Number  CTRI/2024/07/069932 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Use of ultrasound machine to check if central line catheter tip is in right position.  
Scientific Title of Study   Point of care ultrasound to confirm correct positioning of central venous catheter tip -A prospective observational 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  shrasti Tomar  
Designation  Junior Resident 
Affiliation  AIIMS,New delhi 
Address  Anesthesia office room no 5011,floor 5th main AIIMS ward block ,All India Institute of Medical Sciences, New Delhi 110029

South
DELHI
110029
India 
Phone  7065381001  
Fax    
Email  soniginny23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Christopher Dass 
Designation  Assistant professor 
Affiliation  AIIMS,New delhi 
Address  Anesthesia office room no 5011,floor 5th main AIIMS ward block ,All India Institute of Medical Sciences, New Delhi 110029

South
DELHI
110029
India 
Phone  9560177416  
Fax    
Email  christopherdass25@gmail.com  
 
Details of Contact Person
Public Query  
Name  shrasti Tomar  
Designation  Junior Resident 
Affiliation  AIIMS,New delhi 
Address  Anesthesia office room no 5011,floor 5th main AIIMS ward block ,All India Institute of Medical Sciences, New Delhi 110029

South
DELHI
110029
India 
Phone  7065381001  
Fax    
Email  soniginny23@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi 110029  
Type of Sponsor  Research institution and hospital 
 
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 Shrasti Tomar  AIIMS New Delhi  Anesthesia office room no 5011, floor 5th main AIIMS ward block ,AIIMS New Delhi 110029
South
DELHI 		 7065381001

soniginny23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil  
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I, II
Age 18 years and above
site: internal jugular vein, subclavian vein  
 
ExclusionCriteria 
Details  Age less than 18 years
Refusal to participate 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the Accuracy of bedside Ultrasonography in detecting central venous catheter tip correct position.  24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of average amount of time required to complete ultrasonography assessment and reporting vs chest x ray acquisition and reporting.
Feasibility of performing ultrasound
To detect pneumothorax
 		 24hrs 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
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 - NO
Brief Summary  

Central venous catheter (CVC) is used in surgical settings and ICU setups for providing fluid correction, central venous pressure monitoring, for providing total parenteral nutrition, repeated sampling and providing long term intravenous drug infusion. It is also preferred method in patient of difficult cannulation and providing large amount of fluid resuscitation in burns and trauma patient. 

Central venous catheter is typically inserted into the internal jugular vein, subclavian vein and femoral vein. Others alternatives sites include the external jugular vein, cephalic vein and proximal great saphenous vein. It is recommended to perform high frequency linear probe ultrasound to detect the insertion site before using it. This should be done before and after insertion of catheter to detect the CVC tip and other complication The central line tip should be ideally placed at the junction of superior vena cava and right atrium that is cavo-atrial junction.

The complication of CVC depends on the site, patient factors like illness, variation in anatomy and operator skill and experiences. Acute complication can happen like cardiac dysrhythmia, hematoma formation, mechanical injuries to nearby structures like pneumothorax /haemothorax, arterial wall puncture and other rare complications like air embolism, malposition and lost guide wire during insertion.

Conventional chest radiography (CXR) is the current gold standard to examine catheter tip position. Here, chest radiography (CXR) is the current gold standard to examine catheter tip position postoperatively. CXR involves the use of ionized radiation, time consuming and increase in health care expenditure.Use of ultrasound (USG) combined with saline flush or bubble test to determine the CVC tip position.

A rapid injection of 5 ml of agitated saline,as a bolus through catheter, in a stream of microbubble seen in the right atrium through the tip, confirming the tip position. the push to bubble time will be measured to classify the position of tip.

 



 
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