| CTRI Number |
CTRI/2025/10/095778 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the proper placement of right internal jugular venous catheter
inserted using height based formula with a technique called transesophageal echocardiography in
adults undergoing cardiac surgery. |
|
Scientific Title of Study
|
Trans-Esophageal Echocardiographic Assessment Of Tip Position Of Right Internal Jugular Venous Catheter Inserted Using Peres Height Formula In Adults Undergoing Cardiac Surgery |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananya Sharma |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital
Ansari Nagar east, near to Aiims metro station
VMMC and Safdarjung Hospital
Ansari Nagar east, near to Aiims metro station
New Delhi
110029
South
DELHI
110029
India |
| Phone |
7807887999 |
| Fax |
|
| Email |
ananyasharma2272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratiti Choudhuri |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
Ansari Nagar east, near to Aiims metro station
New Delhi
110029
South
DELHI
110029
India |
| Phone |
9831081183 |
| Fax |
|
| Email |
dr.pratiti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratiti Choudhuri |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
Ansari Nagar east, near to Aiims metro station
New Delhi
110029
South
DELHI
110029
India |
| Phone |
9831081183 |
| Fax |
|
| Email |
dr.pratiti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia And Intensive Care
VMMC And Safdarjung Hospital
New Delhi
110029 |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia And Intensive Care |
| Address |
VMMC And Safdarjung Hospital
New Delhi
110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya Sharma |
Department of Anaesthesia and Intensive care |
VMMC And Safdarjung Hospital
New Delhi
110029
South
DELHI |
7807887999
ananyasharma2272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safdarjung Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-70 years of either gender belonging to ASA physical status II-III undergoing elective cardiac surgery with intraoperative trans-esophageal echocardiographic monitoring under general anesthesia requiring right internal jugular central venous catheter insertion will be enrolled in this study |
|
| ExclusionCriteria |
| Details |
Deformities and pathologies of the neck, Previous right IJV central venous catheterization, Gross deformities of the chest, Known vascular anomalies, Anticipated difficult TEE probe insertion conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The linear distance between the SVC RA junction and the tip of IJV catheter inserted using Peres height formula on trans esophageal echocardiographic bi caval view |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between the optimal depth of right IJV catheter (in centimeters) as assessed by TEE & Patient height in centimeters, Body weight in kilograms, Gender & the vertical distance between the catheter insertion point to the sternal angle of the patient in centimeters |
Baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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)
|
20/10/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
This is an observational study conducted at a single center in India, involving a sample size of 91 patients. Participants will be adults aged 18 to 70 years, of either gender, classified as ASA physical status 2-3, and scheduled for elective cardiac surgery under general anesthesia. All patients will undergo intraoperative transesophageal echocardiographic (TEE) monitoring and require insertion of a right internal jugular vein (IJV) central venous catheter. The primary objective of the study is to evaluate the position of the right IJV catheter tip by measuring the linear distance between the catheter tip (inserted using Peres height-based formula) and the superior vena cava–right atrium (SVC-RA) junction, as visualized on the bi-caval view in TEE. The secondary objective is to assess the correlation between the optimal depth of catheter insertion (defined as the difference between the catheter depth based on Peres formula and the measured distance from the catheter tip to the SVC-RA junction) and the patient’s height, weight, gender, and vertical distance from the catheter insertion site to the sternal angle. |