| CTRI Number |
CTRI/2018/05/013670 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
24/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Ultrasound guided measurements of diameters of Subclavian vein and IJV for fluid volume status and to see their variations in mechanically ventilated and spontaneously breathing patients in ICU . |
|
Scientific Title of Study
|
Respirophasic variations of sonographically measured subclavian vein and internal jugular vein dimensions 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 |
Aditi Ranaut |
| Designation |
Post graduate student |
| Affiliation |
Dr RPGMC Tanda at Kangra |
| Address |
Department of anaesthesia
Dr RPGMC Tanda at Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418323381 |
| Fax |
|
| Email |
aditiranaut04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr RPGMC Tanda at kangra |
| Address |
Department of anaesthesia
Dr RPGMC Tanda at kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr RPGMC Tanda at kangra |
| Address |
Department of anaesthesia
Dr RPGMC Tanda at kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia,Dr. RPGMC Kangra at Tanda Himachal pradesh- 176001 |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Tanda at Kangra |
| Address |
Department of Anaesthesia, Dr RPGMC Tanda at Kangra-176001 H.P. |
| 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 |
| Aditi Ranaut |
Dr. RPGMC Kangra at Tanda |
Anaesthesia ICU,first floor, Dr RPGMC Kangra at Tanda, Himachal Pradesh 176001
Kangra
HIMACHAL PRADESH |
9418323381
aditiranaut04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. RPGMC Kangra at Tanda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients admitted in ICU, spontaneously as well as mechanically ventilated., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients in ICU
Spontaneously as well as mechanically ventilated patients |
|
| ExclusionCriteria |
| Details |
1 patients for whomever ultrasound examination would not be appropriate
2 obstetrics patients
3 patients undergone abdominal surgeries and ascitis
4 History of radiotherapy and surgery of neck region
5 Cardiac arrythmias
6 DVT in upper extremities
7 Clinically significant tricuspid and mitral regurgitation
8 patients having PaO2/FiO2 less than 200
9 patients with right sided CVP in situ |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respirophasic variations in sonographically measured subclavian vein and internal jugular vein dimensions in intensive care unit patients. |
5-10 days according to the length of stay in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Implications of respirophasic variations in dimensions of subclavian vein and IJV on fluid status assessment in spontaneously breathing and mechanically ventilated patients.
To observe the best predictor ( USG guided subclavian or IJV) in predicting fluid status in mechanically ventilated and spontaneously breathing patients in ICU. |
5-10 days |
|
|
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)
|
07/05/2018 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The assessment of intravascular fluid volume status in patients admitted to ICU is essential,not only for diagnosis and treatment but also to improve patient’s monitoring. Although clinical examination and other static(CVP, pulmonary artery wedge pressure,stroke volume) as well as dynamic measures (stroke volume variation, pulse pressure variation) are used but USG is convenient, safe,non invasive,economical, easily obtainable, performed at bedside and encouraging results have been observed with USG based parameters used for CVP estimation. So we intend to do ultrasonographic measurements of IJV and subclavian vein to observe fluid volume status and respiropha variations in ICU patients. |