| CTRI Number |
CTRI/2024/06/069327 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of two techniques to measure heart function in critically ill patients |
|
Scientific Title of Study
|
Relationship Of Tissue Doppler Imaging Systolic Velocity With Mitral Annular Plane Systolic Excursion And Left Ventricular Ejection Fraction By Modified Simpsons Method Using Cardiac Ultrasound An Observational Analytical 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 |
Nishant Kumar |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
7th floor ICU
Department of Anaesthesia
Shahid Bhagat Singh Marg
New Delhi DELHI 110001 India |
| Phone |
09811934659 |
| Fax |
|
| Email |
kumarnishant@yahoo.co.uk |
|
Details of Contact Person Scientific Query
|
| Name |
Pooja Panchal |
| Designation |
PG Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
7th floor ICU
Department of Anaesthesia
Shahid Bhagat Singh Marg
New Delhi DELHI 110001 India |
| Phone |
7234963067 |
| Fax |
|
| Email |
panchalpoojakgmu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Pooja Panchal |
| Designation |
PG Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
7th floor ICU
Dept. of Anaesthesia
Shahid Bhagat Singh Marg
DELHI 110001 India |
| Phone |
7234963067 |
| Fax |
|
| Email |
panchalpoojakgmu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Lady Hardinge Medical College
Shahid Bhagat Singh Marg
New Delhi India 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Shahid Bhagat Singh Marg New Delhi India 110001 |
| 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 Nishant Kumar |
Lady Hardinge Medical College |
7th Floor ICU
Department of Anaesthesia
Shahid Bhagat Singh Marg New Delhi 110001 New Delhi DELHI |
9811934659
kumarnishant@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge Medical College & Associated Hospitals New Delhi 110001 India |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients admitted to the intensive care unit
2. Patients more than 18 years and less than 60 years in age
3. Patients of either sex
|
|
| ExclusionCriteria |
| Details |
1. Patients with cardiac valvular pathologies
2. Patients with poor cardiac window
3. Rhythm other than sinus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spearman correlation of TDI s’ with MAPSE and ejection fraction by modified Simpson’s method. |
Measurements shall be made only once in one patient for the first 60 patients during the stay in ICU for the purpose of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Equation for the relationship between TDI s’ & left ventricular EF by Modified Simpson’s method.
2. Mean/Median time taken to measure TDI s’, MAPSE & EF by Modified Simpson’s method using 1 way ANOVA/ Friedman’s ANOVA test.
3. Comparison of ejection fraction from our equation, equation given my Matos et al [3]
and modified Simpson’s method using 1-way ANOVA test or Friedman’s test.
4. Validation of derived equation by calculating bias & precision as compared to the other two methods using Bland Altman analysis.
5. Determination of agreement of ejection fraction obtained by TDIs’, MAPSE & modified Simpson’s method.
6. Cutoff value of TDIs’ to predict low left ventricular ejection fraction using receiver operating characteristics (ROC) curve analysis. |
1. Calculations will be performed for the values obtained after first 60 patients have been recorded.
2-6. Calculations will be performed after the observations in 120 patients at the end of study
Values will be recorded at the time of diagnostic scan & only once in each patient |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
29/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="2" Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Point of care cardiac ultrasound is
universally accepted as one of the most important tools for the assessment of
the cardiac function of a patient. The ejection fraction is often taken as an
indicator for left ventricular function and is a cornerstone for deciding
management and interventions. However, there are various methods to assess Left
ventricular ejection fraction (LVEF). The standard accepted method is the
modified Simpson’s method. This entails calculation of end-diastolic volume
(EDV) and end-systolic volume (ESV) from the area of left ventricle using two
views, thereby calculating LVEF. This measurement
may not be accurate if the entire left ventricle is not visible, or the window
is poor. It may take time to acquire the desired view, and as measurements are
made in two views, precious time may be wasted, especially for an urgent
assessment
Ventricular systole is a result of
the contraction of longitudinal and circumferential fibers of the heart. The
mitral annulus plane systolic excursion occurs as a result of the contraction
of longitudinal fibers. It is hence a representative of the myocardial
contractility and the ejection fraction. This displacement can be easily
measured on M-mode of a cardiac ultrasound and is known as mitral annular plane
systolic excursion or MAPSE.2 The average of septal and lateral
movement of the mitral valve may correlate directly with myocardial
contractility. It is technically easier to obtain and can even be attempted
with good accuracy by an untrained hand. But it requires the lateral mitral
annulus to move in the same plane of M-Mode cursor, which may be difficult to
achieve under suboptimal conditions
Tissue Doppler Imaging (TDI) uses
the principle of pulse wave doppler. High velocity low amplitude signals from
RBCs are eliminated to display only the low velocity high amplitude signals for
the myocardium. The two initial positive velocities correspond to LV isovolumic
contraction velocity and peak systolic contraction velocity (s’) respectively
Peak systolic velocity is a
sensitive marker of calculating Left Ventricle systolic function. TDI is
technically much easier and has the lowest intra & inter observer
variability. TDI s’ therefore could prove to be a reliable substitute and it
could offer a choice to the clinician between the three methods for left
ventricular ejection fraction assessment, which is especially advantageous in
emergent conditions
LACUNAE IN EXISTING LITERATURE
There are only a few reported studies
establishing a relationship of TDIs’ with MAPSE and LVEF, mainly in the western
population with moderate success. There is no universal equation available to
calculate left ventricular ejection fraction from TDI s’. This study is
therefore being designed to find the relationship of TDI s’ with MAPSE and left
ventricular ejection fraction measured by modified Simpson’s method and to
derive and validate a generalized equation for the same. |