| CTRI Number |
CTRI/2024/01/061139 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Internal Jugular vein Collapsibility and IVC Collapsibilty with CVP measurement. |
|
Scientific Title of Study
|
Comparative Analysis of IJV Collapsibility Index vs. IVC Collapsibility Index by Point of Care Ultrasound with Direct CVP Estimation: A Comparative 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 |
Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
BJGMC and SGH, Pune |
| Address |
Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001
Pune MAHARASHTRA 411001 India |
| Phone |
08983741147 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
BJGMC and SGH, Pune |
| Address |
Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001
MAHARASHTRA 411001 India |
| Phone |
08983741147 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
BJGMC and SGH, Pune |
| Address |
Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001
MAHARASHTRA 411001 India |
| Phone |
08983741147 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sassoon General Hospital, Pune |
|
|
Primary Sponsor
|
| Name |
Sujit Kshirsagar |
| Address |
Dept of Trauma care centre, BJGMC and SGH, Pune |
| 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 Sujit Kshirsagar |
Sassoon General Hospital, Pune |
Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001 Pune MAHARASHTRA |
8983741147
bjsujit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, B.J. Govt. Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T149||Unspecified injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age 18 to 65 yrs.
2. Patients admitted in intensive care unit.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had a history of radiotherapy or surgery to the neck or chest
2. Patients with pulmonary hypertension, severe tricuspid regurgitation
3. Patients with previous or active upper extremity deep venous thrombosis
4. Pregnant women will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the correlation between IJV-CI, IVC-CI and direct CVP measurements. |
At the time of admission in intensive care unit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
10/01/2024 |
| 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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Introduction: - Hemodynamic
assessment is a critical aspect of patient care, particularly in situations
where accurate estimation of central venous pressure (CVP) is essential for
guiding clinical management. Traditional methods of CVP measurement involve
invasive procedures that can lead to complications and are often
time-consuming. In recent years, point-of-care ultrasound (POCUS) has emerged
as a valuable tool for non-invasive hemodynamic assessment. Specifically, the
collapsibility indices of the internal jugular vein (IJV) and inferior vena
cava (IVC) have gained attention as reliable indicators of CVP. This
comparative study aims to evaluate the effectiveness of IJV collapsibility
index and IVC collapsibility index, as determined through POCUS, in estimating
CVP when compared with direct CVP estimation methods.
Material & methods: - This
single-centre, observational, comparative study designed to
assess whether IJV measurements would correlate with that of IVC measurements
and invasively monitored CVP in critically ill
patients. |