| CTRI Number |
CTRI/2020/06/026185 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
26/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
CORRELATION OF TWO METHODS TO ASSESS THE VOLUME STATUS IN CRITICALLY ILL PATIENTS. |
|
Scientific Title of Study
|
CORRELATION OF ULTRASOUND GUIDED IVC COLLAPSIBILITY INDEX WITH CENTRAL VENOUS PRESSURE TO ASSESS THE VOLUME STATUS IN INTENSIVE CARE UNIT PATIENTS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranvinder Kaur |
| Designation |
Professor |
| Affiliation |
ABVIMS Dr RML Hospital |
| Address |
Department of Critical Care Medicine
2nd floor Trauma building
ABVIMS Dr RML Hospital
New Delhi
Central DELHI 110001 India |
| Phone |
9717932744 |
| Fax |
|
| Email |
rsindhoo@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Ranvinder Kaur |
| Designation |
Professor |
| Affiliation |
ABVIMS Dr RML Hospital |
| Address |
Department of Critical Care Medicine
2nd floor Trauma building
ABVIMS Dr RML Hospital
New Delhi
Central DELHI 110001 India |
| Phone |
9717932744 |
| Fax |
|
| Email |
rsindhoo@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Anjane Sree |
| Designation |
PG Resident |
| Affiliation |
ABVIMS Dr RML Hospital |
| Address |
Department of Anesthesiology
3rd floor PGI building
ABVIMS Dr RML Hospital
New Delhi
Central DELHI 110001 India |
| Phone |
8148103365 |
| Fax |
|
| Email |
anjanesree@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS AND DR.RML HOSPITAL
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
3rd floor PGI Building
ABVIMS Dr RML Hospital
New Delhi |
| 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 Anjane Sree |
ABVIMS and Dr RML Hospital |
Department of Critical Care Medicine
2nd floor
Trauma building
ABVIMS and Dr RML Hospital
New Delhi Central DELHI |
8148103365
anjanesree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS Dr RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient >18 yrs of age with a central venous catheter terminating in distal SVC.
2. BMI 18-30 Kg/m2. |
|
| ExclusionCriteria |
| Details |
1. Clinical signs of elevated abdominal pressure.
2. Moderate to severe tricuspid regurgitation.
3. Patients in whom the supine position is contraindicated. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of ultrasound guided collapsibility index and CVP. |
At time of admission to ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of ultrasound guided collapsibility index and CVP. |
After 24 hours of admission to ICU |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
27/06/2020 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bedside assessment of intravascular volume status in critically ill patients is challenging. Fluid management impacts systemic perfusion and may influence the risk of organ failure and mortality. Clinicians often use invasive hemodynamic monitoring as an adjunct to information gathered from the physical examination and laboratory evaluation to arrive at a fluid management strategy. A non-invasive and economical technique like ultrasound in the ICU helps to approach regarding hemodynamic status and treatment of the critically ill patients. The physiologic principle underlying IVC collapsibility index is that during spontaneous breathing, inspiration leads to negative intrathoracic pressure, which in turn leads to three additional effects. Collapsibility of the inferior vena cava has been found to be useful in monitoring response to therapy as well as assisting in ongoing resuscitation by providing means to measure CVP non-invasively. Informed consent will be obtained from all the patients, and they will be assured that the identity of the respondents will be kept anonymous. Before collection of USG data, study ultra-sonographers will be blinded to CVP monitoring. Bedside ultrasound images will be obtained in a systematic fashion with the patient supine to determine the dimensions and collapsibility of the IVC.
Immediately following the ultrasound image acquisition, study personnel will obtain a simultaneous recording of the CVP waveform from the distal lumen of the central venous catheter . The CVP will be uniformly measured from a recording at end expiration with the patient supine and the pressure transducer having been zeroed at the mid-thoracic position. A patient with CVP of less than 8 cmH2O will be considered as hypovolemic. The patients with CVP between 8–12 cmH2O will be considered as euvolemic and patients having CVP > 12 cmH2O will be considered as hypervolemic. Statistical Analysis will be performed using standard statistical methods. |