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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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