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临床试验/NCT03301571
NCT03301571已完成不适用

Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in right ventricular function during CABG assessed with TAPSE

研究概览

简要总结

Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac failure after cardiac surgery substantially. A comprehensive understanding of this condition is paramount in order to achieve success in treatment and early diagnosis.

This study has two main aims.

Perioperative aim:

To investigate correlations between changes in echocardiographic measurements and hemodynamic changes at baseline and following coronary artery bypass graft (CABG) surgery.

Postoperative aim:

To evaluate changes in haemodynamics and echocardiographic parameters during separate physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes (AAI/DDD/VVI)).

详细描述

Clinical procedure:

For the operation standard procedures for anaesthesia, surgery and cardiopulmonary bypass will be used. This includes installment of a pulmonary artery catheter and performing a transesophageal echocardiography. For the purpose of this study additional TEE images and a transthoracic echocardiography (TTE) will be obtained in order to correlate different echocardiographic indices with haemodynamic measurements and investigate any differences between TTE and TEE measurements.

Transthoracic echocardiography (TTE):

Basic TTE will be performed after anaesthesia induction, before surgery commences and repeated immediately after arrival at the ICU.

Image acquisitions from TTE:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective coronary artery bypass graft patients
  • Normal left ventricular function defined as LVEF over 50 % on TTE preoperatively

排除标准

  • Pre-existing right ventricular malformations
  • Severe right ventricular impairment preoperatively
  • Pre-existing non-sinus rhythm
  • Pre-existing mitral valve stenosis or severe regurgitation
  • Pre-existing pulmonary hypertension
  • Pre-existing tricuspid valve stenosis or severe regurgitation
  • Patients with contraindication to TEE probe placement such as oesophageal stricture or obstruction
  • Patients with contraindication to Swan-Ganz catheter placement

研究组 & 干预措施

All patients

Other

All patients will receive the treatment (CABG) and postoperatively three different interventions:

  1. Change in preload and afterload
  2. Change in inspired oxygen
  3. Change in pacemaker modes

干预措施: Change in preload and afterload (Other)

All patients

Other

All patients will receive the treatment (CABG) and postoperatively three different interventions:

  1. Change in preload and afterload
  2. Change in inspired oxygen
  3. Change in pacemaker modes

干预措施: Inspired oxygen (Other)

All patients

Other

All patients will receive the treatment (CABG) and postoperatively three different interventions:

  1. Change in preload and afterload
  2. Change in inspired oxygen
  3. Change in pacemaker modes

干预措施: Pacemaker mode (Other)

结局指标

主要结局

Change in right ventricular function during CABG assessed with TAPSE

时间窗: During a standard CABG operation

Assessing the change in RV function during CABG surgery

次要结局

  • Response in right ventricular function parameter S' to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter Tei index to each intervention(Immediate postoperative period)
  • Change in cardiac output measured with Swan-Ganz during CABG(During a standard CABG operation)
  • Response in right ventricular function parameter RVFAC to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter strain rate during a standard CABG operation(During a standard CABG operation)
  • Response in right ventricular function parameter strain rate to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter RV size to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter RV size during a standard CABG operation(During a standard CABG operation)
  • Right ventricular function assessed with TAPSE after each intervention(Immediate postoperative period)
  • Change in cardiac output measured with Swan-Ganz after each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter RVFAC during a standard CABG operation(During a standard CABG operation)
  • Response in left ventricular function parameter MAPSE during a standard CABG operation(During a standard CABG operation)
  • Response in right ventricular function parameter pulmonary artery flow velocity to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter RVEF during a standard CABG operation(During a standard CABG operation)
  • Change in cardiac output measured with Swan Ganz in response during a standard CABG operation(During a standard CABG operation)
  • Response in right ventricular function parameter S' during CABG(During a standard CABG operation)
  • Response in right ventricular function parameter Tei index during a standard CABG operation(During a standard CABG operation)
  • Response in left ventricular function parameter MAPSE to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter strain % to each intervention(Immediate postoperative period)
  • Response in right ventricular function parameter strain % during a standard CABG operation(During a standard CABG operation)
  • Response in right ventricular function parameter RVEF during CABG(Immediate postoperative period)
  • Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation(During a standard CABG operation)
  • Response in right ventricular function parameter RVEF to each intervention(Immediate postoperative period)
  • Change in cardiac output measured with Swan Ganz in response to each intervention(Immediate postoperative period)
  • Change in hemodynamic pressures in response to each intervention(Immediate postoperative period)
  • Change in hemodynamic pressures during a standard CABG operation(During a standard CABG operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Grønlykke

Principal investigator, MD

Rigshospitalet, Denmark

研究点 (1)

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