| CTRI Number |
CTRI/2026/02/104828 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing heart ultrasound with chest radiography to check if a central line is in the right place in ICU patients. |
|
Scientific Title of Study
|
PROSPECTIVE EVALUATION OF THE ACCURACY AND TIME EFFICIENCY OF THE SALINE
FLUSH ECHOCARDIOGRAPHY TEST COMPARED WITH CHEST RADIOGRAPHY FOR CENTRAL VENOUS CATHETER TIP LOCALIZATION IN INTENSIVE CARE UNIT PATIENTS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANAS OMER |
| Designation |
DNB RESIDENT |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL (MAX SAKET) |
| Address |
1, 2 PRESS ENCLAVE MARG, SAKET INSTITUTIONAL AREA, SAKET, NEW DELHI.
1, 2 PRESS ENCLAVE MARG, SAKET INSTITUTIONAL AREA, SAKET, NEW DELHI.
New Delhi
DELHI
110017
India |
| Phone |
8808079780 |
| Fax |
|
| Email |
manasomer76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omender Singh |
| Designation |
Principal Director, Institute of Critical Care Medicine |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Critical Care Medicine ICUs,
Max Super Speciality Hospital,
1,2 Press Enclave Road, Saket Institutional Area, Saket, New Delhi-110017
New Delhi
DELHI
110017
India |
| Phone |
9205076072 |
| Fax |
|
| Email |
omender.singh@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Manas Omer |
| Designation |
DNB RESIDENT |
| Affiliation |
Max Super Speciality Hospital, Saket |
| Address |
Critical care medicine ICUs,
Max Super Speciality Hospital,
1,2 Press Enclave Road,
Saket Institutional Area, Saket, New Delhi-110017
New Delhi
DELHI
110017
India |
| Phone |
8808079780 |
| Fax |
|
| Email |
manasomer76@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manas Omer |
| Address |
Max Super Speciality Hospital,
1,2 Press Enclave Road, Saket Institutional Area, Saket, New Delhi-110017 |
| Type of Sponsor |
Other [Self] |
|
|
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 Manas Omer |
Max Super Speciality Hospital, Saket |
Medical Intensive Care Units, Critical Care Medicine,
Max Super Speciality Hospital,
1,2 Press Enclave Road, Saket Institutional Area, Saket, New Delhi-110017
New Delhi
DELHI |
8808079780
manasomer76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z452||Encounter for adjustment and management of vascular access device, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18 to 90 years) admitted to ICU requiring central venous catheterization
CVC insertion through internal jugular or subclavian vein using ultrasound guidance
Written informed consent obtained |
|
| ExclusionCriteria |
| Details |
Femoral central venous catheter insertions
PICC or totally implantable port devices
Known cardiac anomalies or congenital heart disease or severe heart failure
Poor echocardiographic windows
Patients on ECMO |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy (sensitivity and specificity) of saline flush echocardiography test compared to chest X-ray for confirming central venous catheter tip position |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for CVC tip position confirmation using saline flush test compared to chest X-ray
Rate of malpositions or complications detected using Peres formula |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
08/03/2026 |
| 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 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
|
This prospective comparative study evaluates the accuracy and time efficiency of saline flush echocardiography test versus chest radiography for confirming central venous catheter tip position in ICU patients. CVCs will be inserted using the Peres formula, followed by both saline flush test and chest X-ray. The study aims to determine if echocardiography provides comparable accuracy with faster confirmation times. |