| CTRI Number |
CTRI/2025/05/087955 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Caval Sonography] |
| Study Design |
Other |
|
Public Title of Study
|
Caval sonography in correlation with central venous pressure for the assessment of volume status in critically ill patients |
|
Scientific Title of Study
|
Caval sonography in correlation with central venous pressure for the assessment of volume status in critically ill patients: A cross - sectional 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 |
Dr Sangeetha Lakshmikanthan |
| Designation |
Post Graduate |
| Affiliation |
Karnataka Institute Of Medical Sciences Hubballi |
| Address |
Department of Anaesthesiology Karnataka Institute Of Medical Sciences Vidyanagar Hubballi Dharwad karnataka 580021 India
Dharwad
KARNATAKA
580021
India |
| Phone |
9080757987 |
| Fax |
|
| Email |
sange.kanthan93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagadish B Alur |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute Of Medical Sciences Hubballi |
| Address |
Department of Anaesthesiology Karnataka Institute Of Medical Sciences Vidyanagar Hubballi Dharwad karnataka 580021 India
Dharwad
KARNATAKA
580021
India |
| Phone |
9449455665 |
| Fax |
|
| Email |
alurjaggs9495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagadish B Alur MD |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute Of Medical Sciences Hubballi |
| Address |
Department of Anaesthesiology Karnataka Institute Of Medical Sciences Vidyanagar Hubballi Dharwad karnataka 580021 India
Dharwad
KARNATAKA
580021
India |
| Phone |
9449455665 |
| Fax |
|
| Email |
alurjaggs9495@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Medical College and Research Institute (KMC-RI), PB Road, Vidya Nagar, Hubballi, Karnataka, INDIA- 580022 |
|
|
Primary Sponsor
|
| Name |
Dr Sangeetha Lakshmikanthan |
| Address |
Post Graduate Department Of Anaesthesiology
Karnataka Medical College and Research Institute (KMC-RI),PB Rd, Vidya Nagar, Hubballi, Karnataka, India - 580022 |
| 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 Sangeetha Lakshmikanthan |
Karnataka institute Of Medical Sciences |
Department Of Anaesthesiology Room No 206 Karnataka Institute Of Medical Sciences Vidyanagar Hubballi
Dharwad
KARNATAKA |
9080757987
sange.kanthan93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute Of Medical Sciences Hubballi 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 |
Caval Sonography |
Bedside ultrasonographic examination of Inferior Vena Cava will be performed in critically ill patients to measure IVC diameters and IVC collapsibility index for 5 minutes |
| Comparator Agent |
Central Venous Pressure measurement |
Immediately after measuring the IVC diameters and IVC collapsibilty index recording of central venous pressure will be done using the manometer technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients in intensive care unit, Spontaneously breathing patients, patients with functioning Central venous catheter that had already been placed for clinical indications, patients giving informed valid and written consent |
|
| ExclusionCriteria |
| Details |
Patients in whom CVC is contraindicated, patients with overt right heart failure or with moderate to severe tricuspid regurgitation, patients with clinical signs of elevated intra abdominal pressure, Patients for whom required ultrasound examination would not be appropriate , mechanically ventilated patients, patients who refused to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between inferior vena cava diameters, central venous pressure and IVC collapsibility index for estimating the volume status in critically ill patients |
Ultrasound image acquisition recording will be done initially. After one minute central venous pressure will be measured |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish inferior vena cava diameter & IVC collapsibility index as a non invasive tool for the evaluation of intravascular fluid volume & to guide fluid management in critically ill patients |
Baseline USG guided IVC diameter & IVC collapsibility index obtained. After 1 minute CVP will be measured & values will be correlated |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="11"
Days="1" |
|
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
|
Accurate assessment of intravascular volume status in critically-ill patients is crucial for their diagnosis and management. Traditional CVP measurement requires invasive central venous catheter placement which is time consuming and is associated with potential complications. Clinician performed bedside ultrasonographic evaluation of the IVC is a potential tool that could provide an instant and non-invasive measure of volume status. This cross sectional study aims to establish the accuracy of ultrasonography as a feasible, rapid and non-invasive method for assessment of intravascular volume status in spontaneously breathing critically ill patients. |