跳至主要内容
临床试验/CTRI/2022/05/042808
CTRI/2022/05/042808招募中不适用

Cardiac output measurement using Trans-esophageal echocardiography versus Thermodilution in patients undergoing off-pump CABG

G B Pant hospital GIPMER New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
1.Cardiac output by thermodilution method

研究概览

简要总结

Perioperative cardiac function monitoring plays a crucial role in the assessment, treatment, and prognosis of patients undergoing cardiac surgery of which Cardiac output (CO) measurement is one of the most important parameters.

Pulmonary artery catheter (PAC) is used to measure CO by thermodilution (TD) technique and is still considered as gold standard method since 1970s when it was first introduced by Dexter et al and further modified by William Ganz et al.

PAC is invasive and is associated with numerous complications like pneumothorax, arrhythmia, infection, pulmonary artery rupture, valve injury, knotting and thrombo-embolism. It is prone to technical errors due to loss of injectate, temperature variability, thermistor malfunction, coiling of catheter or variability in timing of injectate. Intracardiac shunts, mechanical ventilation and valvular dysfunction may lead to incorrect interpretation. This led to the development of less invasive methods of CO monitoring such as Echocardiography, thoracic electrical bioimpedance, and magnetic resonance imaging, arterial wave contour analysis, PiCCO, transpulmonary thermodilution, transpulmonary lithium dilution which have questionable benefits during open-heart cardiovascular surgery.

Trans-esophageal echocardiography (TEE) allows both cardiac structure and functions evaluation. Valvular pathology can also be detected by it. However, it requires training and skills by the operator and has a higher cost. Certain requirements must be fulfilled: (a) the absence of turbulence (b) parallel orientation of the Doppler beam to the direction of the blood flow in the left ventricle outflow tract (LVOT) and aortic valve. Various routes for CO measurements are: at the level of pulmonary artery (PA), mitral valve (MV) or aortic valve (AV) and at left ventricular outflow tract (LVOT) with pulsed wave doppler (PWD) and continuous wave doppler (CWD).

It has been observed that use of PAC in elective coronary artery bypass graft (CABG) surgery increases patients risk adjusted mortality and morbidity. In addition, TEE provides cause of low CO, hemodynamic instability and other associated lesions such as aortic pathology. TEE has been shown to improve mortality. Hence, if CO measurement by PAC and TEE are comparable or if TEE method is superior, use of PAC can be avoided in CABG patients. With lesser complications than PA catheter based thermodilution techniques, we would like to assess if TEE based CO measurement can be interchanged with the latter in patients undergoing off pump coronary artery bypass graft (OPCAB) as use of TEE is recommended (Class I) for intra-operative monitoring of CABG patients.

Lacunae in existing knowledge:

Whether echocardiography can replace thermodilution method in CO measurement still remains controversial. Certain studies including systematic reviews and meta-analysis show good correlation between TEE and TDwhile others have concluded TEE cannot be interchanged with TD and have suggested further evaluation. The accuracy of CO measurement using TEE has not been adequately validated, especially in CABG surgeries.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adult patients undergoing off pump CABG with LVEF less than 50%.

排除标准

  • 1.Patients with mitral/aortic valve insufficiency or other significant valve abnormalities 2.Patients in non-sinus rhythm 3.Patients requiring inotropic support/IABP/haemodynamically unstable pre-operatively 4.Patients with right ventricular assist device 5.Patients with esophageal diseases 6.Patients requiring conversion from off pump CABG to on pump CABG 7.Patients with ventricular septal defects (VSD) and right ventricle outflow tract (RVOT) / LVOT obstruction.

结局指标

主要结局

1.Cardiac output by thermodilution method

时间窗: T1: Clinical steady state 15minutes after induction of anaesthesia | T2: After sternal closure

2.Cardiac output by trans-esophageal echocardiography at aortic valve level

时间窗: T1: Clinical steady state 15minutes after induction of anaesthesia | T2: After sternal closure

次要结局

  • 1.Hemodynamic monitoring including heart rate, systolic, diastolic and mean arterial pressures and pulmonary artery pressure.(Every 60minutes throughout the operative period)
  • 2.Complications associated with each technique(intra-operative and post-operative till patient is discharged from ICU)
  • Clinical outcome assessment:(a)Total inotropic score)

研究者

发起方
G B Pant hospital GIPMER New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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