| CTRI Number |
CTRI/2024/10/075236 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study for comparison of left heart pressure measured by lung blood flow via ultrasound of heart with left heart pressure by direct insertion of needle in patients undergoing elective bypass surgery |
|
Scientific Title of Study
|
Study to compare left atrial pressure measured by pulmonary venous flow via transesophageal echocardiography with left atrial pressure via direct needle insertion in patients undergoing elective off pump coronary artery bypass grafting |
| 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. Akif Ahmed Kichloo |
| Designation |
Senior Resident Cardiac anaesthesia |
| Affiliation |
G B Pant Institute of Post Graduate Medical Education and Research |
| Address |
Department of Anaesthesiology, 6th floor, Academic Block, G B Pant Hospital, New Delhi
New Delhi DELHI 110002 India |
| Phone |
8492829925 |
| Fax |
|
| Email |
aakifkichloo@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rachna Wadhwa |
| Designation |
Professor, Department of anaesthesiology, cardiac anesthesia unit |
| Affiliation |
GIPMER |
| Address |
Department of Anaesthesiology, 6th floor, Academic Block G B Pant Hospital, New Delhi
New Delhi DELHI 110002 India |
| Phone |
9891943326 |
| Fax |
|
| Email |
drrachnawadhwa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rachna Wadhwa |
| Designation |
Professor, Department of anaesthesiology, cardiac anesthesia unit |
| Affiliation |
GIPMER |
| Address |
Department of Anaesthesiology, 6th floor, Academic Block G B Pant Hospital, New Delhi
New Delhi DELHI 110002 India |
| Phone |
9891943326 |
| Fax |
|
| Email |
drrachnawadhwa@gmail.com |
|
|
Source of Monetary or Material Support
|
| GIPMER New Delhi India 110002 |
|
|
Primary Sponsor
|
| Name |
GIPMER, NEW DELHI |
| Address |
Department of Anaesthesiology, 6th floor, Academic Block G B Pant Hospital, New Delhi DELHI 110002 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akif Ahmed Kichloo |
G B Pant Hospital |
Cardio-thoracic and vascular surgery operation theatre, 2nd and 5th Floor, B
Block New Delhi DELHI |
8492829925
aakifkichloo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
LVEF MORE THAN AND EQUAL TO 50 PERCENT |
|
| ExclusionCriteria |
| Details |
Mitral/aortic valve or other significant valve abnormalities
Non-sinus rhythm
Inotropic support/ IABP/hemodynamically unstable patient pre-operatively
Patients on ventricular assist device
Patients requiring conversion from off pump CABG to on pump CABG
Critical left main coronary artery disease
Intracardiac shunts
Congenital Heart disease
Redo surgery
Patients with known contraindications for the insertion of TEE
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Deceleration time of pulmonary vein diastolic wave (DT(D))
2. Left atrial pressure (LAP) measured directly via needle insertion |
Immediately post sternotomy and 15 minutes after protamine administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Calculated LAP via E/e prime
2. Left Atrial Diameter
3. NT pro BNP levels
|
Immediately post sternotomy & 15 minutes after protamine administration
|
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
30/10/2024 |
| 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="0" |
|
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
|
Historically, the pulmonary artery catheter (PAC) has been utilized for measuring cardiac filling pressures, with pulmonary capillary wedge pressure (PCWP) serving as a proxy for left atrial pressure (LAP) and left ventricular end-diastolic pressure. Numerous extensive studies have demonstrated a correlation between PCWP and LAP in patients afflicted with cardiovascular diseases. Assessing left atrial pressure (LAP) is integral to the evaluation of left ventricular diastolic function. Increased left ventricular filling pressures are predictive of unfavourable long-term outcomes, even in individuals with normal ejection fractions. Furthermore, a restrictive diastolic filling pattern has been associated with heightened major morbidity and mortality rates in patients undergoing cardiac surgery. The utility of the pulmonary artery catheter (PAC) in the perioperative setting has come under scrutiny, as numerous extensive studies have failed to conclusively establish its benefits across patient cohorts. Consequently, its utilization during the perioperative period has dwindled. There is now a growing need for alternative non-invasive approaches to estimate left-sided filling pressures. In the absence of mitral valve disease, left atrial pressure (LAP) is often considered equivalent to left ventricular end-diastolic pressure (LVEDP). Various echocardiographic parameters have been confirmed for assessing left ventricular filling pressures (LVFP). Among these, the ratio of mitral early diastolic velocity to early diastolic mitral annular velocity (E/e′) is commonly utilized and has been found to be superior among available Doppler indices. The e′ velocity, representing mitral annular velocities, adjusts the E wave velocity for relaxation impact. A lateral E/e′ ratio of ≥12 or septal E/e′ ratio of ≥15 correlates with an elevated left atrial pressure (LAP). However, E/e′ may lack reliability in conditions where the mitral annulus is tethered by calcium or a prosthetic ring, as well as in left ventricular disorders like hypertrophic cardiomyopathy and regional wall motion abnormalities. Therefore, this study aimed to identify a parameter capable of indirectly estimating left atrial pressure (LAP) irrespective of left ventricular and mitral valve disorders. The deceleration time of the pulmonary vein diastolic wave (DT(D)) has shown strong correlations with invasive pulmonary capillary pressure in numerous studies, independent of left ventricular systolic function and mitral annular disorders. However, the practical application is hindered by challenges in recording pulmonary venous flow (PVF) from apical windows in critically ill patients using transthoracic echocardiography. Transesophageal echocardiography offers a superior imaging window for visualizing pulmonary veins, given their posterior location. Additionally NT pro-BNP levels have been found to have strong linear correlation with LAP. Therefore, this study aims to correlate transesophageal echocardiography (TEE)-derived deceleration time of the pulmonary vein diastolic wave (DT(D), calculated left atrial pressure (LAP) obtained by the E/e’ ratio, and LAP measured directly via needle insertion in patients with coronary artery disease undergoing off-pump coronary artery bypass grafting (OPCAB). Additionally, NT-proBNP samples will be collected at the beginning of surgery
PCWP, an invasive technique, is considered the gold standard for estimating left atrial pressure. The use of non-invasive methods in place of pulmonary artery catheterization is still controversial. There are various studies comparing PCWP and E/e’ via TTE but very few studies comparing (TEE)-derived deceleration time of the pulmonary vein diastolic wave DT(D) and LA pressure measured directly via needle insertion. Even those studies that have been done have varying and contradictory findings. Therefore this study is designed to compare DT(D) measured via TEE and left atrial pressure obtained directly via needle insertion in patients undergoing elective Off pump CABG. |