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临床试验/CTRI/2024/10/075236
CTRI/2024/10/075236
尚未招募
不适用

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

GIPMER, NEW DELHI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月30日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
GIPMER, NEW DELHI
入组人数
40
试验地点
1
主要终点
1. Deceleration time of pulmonary vein diastolic wave (DT(D))

概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • LVEF MORE THAN AND EQUAL TO 50 PERCENT.

排除标准

  • 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.

结局指标

主要结局

1. Deceleration time of pulmonary vein diastolic wave (DT(D))

时间窗: Immediately post sternotomy and 15 minutes after protamine administration

2. Left atrial pressure (LAP) measured directly via needle insertion

时间窗: Immediately post sternotomy and 15 minutes after protamine administration

次要结局

  • 1. Calculated LAP via E/e prime(2. Left Atrial Diameter)

研究者

发起方
GIPMER, NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Akif Ahmed Kichloo

G B Pant Institute of Post Graduate Medical Education and Research

研究点 (1)

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