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CTRI Number  CTRI/2024/12/078278 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   central line catheter position confirmation with the use of ultrasound 
Scientific Title of Study   Peripherally inserted central catheter (PICC) tip confirmation with echocardiography using Rapid atrial swirl sign - An 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  Indubala Maurya 
Designation  Associate Professor 
Affiliation  Kalyan Singh Super Specialty Cancer Institute  
Address  Department of Anaesthesiology Kalyan Singh Super Specialty Cancer Institute, CG City

Lucknow
UTTAR PRADESH
226002
India 
Phone  07639769237  
Fax    
Email  indubala.maurya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indubala Maurya 
Designation  Associate Professor 
Affiliation  Kalyan Singh Super Specialty Cancer Institute  
Address  Department of Anaesthesiology Kalyan Singh Super Specialty Cancer Institute, CG City


UTTAR PRADESH
226002
India 
Phone  07639769237  
Fax    
Email  indubala.maurya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Indubala Maurya 
Designation  Associate Professor 
Affiliation  Kalyan Singh Super Specialty Cancer Institute  
Address  Department of Anaesthesiology Kalyan Singh Super Specialty Cancer Institute, CG City


UTTAR PRADESH
226002
India 
Phone  07639769237  
Fax    
Email  indubala.maurya@gmail.com  
 
Source of Monetary or Material Support  
Kalyan Singh Super Speciality Cancer institute, Golf City, Chak Kajehra, Uttar Pradesh, India 226002 
 
Primary Sponsor  
Name  Kalyan Singh Super Speciality Cancer institute 
Address  Department of Anaesthesiology Kalyan Singh Super Specialty Cancer Institute, CG City Lucknow UTTAR PRADESH 226002 India  
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 Indubala Maurya  Kalyan Singh Super Specialty Cancer Institute  1st Floor, OT Complex, Department of Anaesthesiology Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH 		 7639769237

indubala.maurya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Kalyan Singh Super Specialty Cancer Institute (KSSSCI)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients of either gender, aged 18-65 years, who are planned for ultrasound-guided peripherally inserted central catheter insertion on either side. 
 
ExclusionCriteria 
Details  Known case of structural heart disease
Patients with a pacemaker and/or implantable cardioverter-defibrillator
Rhythm abnormalities
History of thoracic surgeries or trauma
History of heart or great vessel surgery
Hemodynamically unstable patients
Body Mass Index > 30
Postoperative patients underwent abdominal surgeries, head and
neck surgeries. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To calculate sensitivity and specificity of rapid right atrial swirl sign in subcostal bicaval view during echocardiography
 		 Immediatley after PICC line insertion. 
 
Secondary Outcome  
Outcome  TimePoints 
To Calculate the positive predictive value & negative predictive value of the rapid
atrial swirl sign in the subcostal bicaval view duing echocardiography 		 Immediately after PICC line insertion. 
To describe characteristics of the RASS with different PICC tip positions on chest X-ray.  Immediately after PICC line insertion 
To find the incidence of malposition after USG-guided PICC insertion.  Immediately after PICC line insertion 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/01/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The incidence of post-insertion PICC tip malposition is 7.8-18 %. The catheter tip malposition can lead to complications, including arrhythmias, precordial discomfort, cardiac tamponade and heart valve damage, swelling, pain in the limb on the affected side, etc. Thus, confirming the correct positioning of PICC in the superior vena cava (SVC) at or before the junction with the right atrium is obligatory. The most common method to ensure correct PICC tip position is the post-procedural chest x-ray (CXR) or considering fluoroscopy-guided insertion. Traditionally, post-procedure chest X-ray has been considered “ Gold standard”. Ultrasound guidance has become a routine practice to guide PICC insertion. However, the use of point of care ultrasound to confirm the correct position of the PICC tip in adults is limited.This study aims to find the diagnostic accuracy of rapid atrial swirl signs in subcostal bicaval view in bedside echocardiography to detect optimal PICC tip position.  
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