| CTRI Number |
CTRI/2020/12/029858 [Registered on: 16/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
TO STUDY AND COMPARE THE CHANGES IN DIMENTION WITH BREATHING OF INTERNAL JUGULAR VEIN AND INFERIOR VENA CAVA IN NORMAL PATIENTS AND PATIENTS WITH HEART DISEASE. |
|
Scientific Title of Study
|
TO STUDY AND COMPARE THE DIMENSIONS AND RESPIRATORY VARIATIONS OF INTERNAL JUGULAR VEIN AND INFERIOR VENA CAVA IN STABLE CARDIAC AND NON CARDIAC PATIENTS - A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maninder Singh Raizada |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC, Kangra at Tanda |
| Address |
junior resident,
department of anesthesia,
ssb2, ot complex,
dr. rpgmc
kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8988385356 |
| Fax |
|
| Email |
manirana946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Bhandari |
| Designation |
Associate professor |
| Affiliation |
Dr. RPGMC, Kangra at Tanda |
| Address |
department of anesthesia,
ssb 2,ot complex
dr. rpgmc
kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805135129 |
| Fax |
|
| Email |
dr.bhandari@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maninder Singh Raizada |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC, Kangra at Tanda |
| Address |
junior resident,
department of anesthesia,
ssb 2, ot complex
dr. rpgmc
kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8988385356 |
| Fax |
|
| Email |
manirana946@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Govt Medical College, Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Dr. Rajendra Prasad Govt Medical College, Kangra at Tanda |
| 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 Maninder singh Raizada |
Dr. RPGMC Tanda |
Dr. rajendra prasad govt medical college,2nd floor Main OT Complex
kangra at tanda
Kangra
HIMACHAL PRADESH |
8988385356
manirana946@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra prasad government medical college Kangra at tanda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients of non cardiac diseases coming to hospital |
| Patients |
(1) ICD-10 Condition: I422||Other hypertrophic cardiomyopathy, (2) ICD-10 Condition: I425||Other restrictive cardiomyopathy, (3) ICD-10 Condition: I420||Dilated cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 >18 year of age
2 DCMP without decompensation
3 RCMP without decompensation
4 HCM without decompensation
5 CAD: Ischemic Cardiomyopathy
6 Valvular heart disease without decompensation excluding TR
7 Pulmonary HTN without RV failure
|
|
| ExclusionCriteria |
| Details |
• Patient’s unwillingness to participate in study.
• Patients who are unable to lie in supine position
• Uncooperative patients who are not able to understand the commands.
• Patients who are obese with BMI >30.
• Patients who are k/c/o Chronic liver disease/ Portal HTN
• Patients who are k/c/o ADHF, Stable CAD, RV dysfunction.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study and compare the IJV and IVC diameter and CSA in stable cardiac and non cardiac patients.
2. To study the effect of respiratory variations in the diameter of IJV and IVC in stable cardiac patients.
3. To study the effect of respiratory variations in the diameter of IJV and IVC in non cardiac patients.
4. To find the relation between collapsibility index of IJV and IVC in stable cardiac and non cardiac patients.
|
with in one years from commencement of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find any relation between height, weight and BMI and dimensions of IJV and IVC.
2. To find any gender and site differences in dimensions of IJV and IVC.
|
with in one years from commencement of study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
23/12/2020 |
| 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)?
Response - NO
|
|
Brief Summary
|
Assessment of degree of hypovolemia is key step
in adequate management and outcome of patients. Many times patients end up with
the under hydration or fluid overload due to poor assessment of blood loss
which have deleterious effect on patients outcome.-invasive evaluation of central venous pressure
(CVP) is a component of the physical examination that can be very valuable in
patient care, especially in the assessment of volume status. Measurement of end
expiratory diameter of the IJV by USG in supine position exhibited a high
correlation to CVP. Point-of-care ultrasound (POCUS) is convenient,
safe, non invasive, economical, easily obtainable, performed at the bedside |