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临床试验/NCT04167241
NCT04167241Unknown不适用

Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection

Humanitas Clinical and Research Center0 个研究点目标入组 50 人开始时间: 2019年11月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Prevalence of right ventricle disfunction

研究概览

简要总结

Major lung resection is associated with high post-operative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications.

RV (Right Ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. The RV is exquisitely sensitive to changes in afterload. When pulmonary vascular reserve is compromised RV ejection may be also compromised, increasing right atrial pressure and limiting maximal cardiac output. Acute increase in RV outflow resistance, as may occur with acute pulmonary embolism will cause acute RV dilatation and, by ventricular interdependence, markedly decreased LV (Left Ventricle) compliance, rapidly spiraling to acute cardiogenic shock and death.

Most of the studies on RV function after lung resection are small and have found different results, and sometimes conflicting findings. As far as the investigators know, there are no data on the incidence of the RV dysfunction after major lung resection (pneumonectomy/bilobectomy) and it's not clear if there is some direct association between the RV dysfunction and post-operative complications. If so, early detection of RV dysfunction after major lung resection could provide the opportunity for interventional therapy with consequent possible improvement of these patients' prognosis.

详细描述

The aim of this study is to identify the incidence of early RV systolic dysfunction (defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 cm, S' (TDI) < 10 cm/s) and estimate the RV-PA (Right Ventricle-Pulmonary Artery) coupling as indicated by Guazzi et all. (TAPSE/PAPs ratio, where PAPs is the Systolic Pulmonary Artery Pressure) after major lung resection (bilobectomy and pneumonectomy) using echocardiography, and to assess if these modifications (RV dysfunction and RV-PA coupling) may be associated with post-operative cardiopulmonary complications occurring during the hospitalization period. Investigators also intend to evaluate if these changes are associated with impaired functional capacity at 3 months after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients undergoing right pneumonectomy
  • Adults patients undergoing pulmonary bilobectomy

排除标准

  • Left pneumonectomy (it will not permit TTE postoperatively)
  • Completion pneumonectomy
  • Patients suffering from any myocardial disease
  • Preceding Pulmonary Embolism
  • Pregnancy
  • Potential pregnancy
  • Patients enrolled into another trial

结局指标

主要结局

Prevalence of right ventricle disfunction

时间窗: Immediately after the awakening from general anesthesia (Day 0)

Incidence of early RV systolic dysfunction (defined as TAPSE \< 17 mm, S' (TDI) \< 10 cm/s) and estimate the RV-PA coupling as indicated by Guazzi et al. (TAPSE/PAPs ratio mm/mmHg) after major lung resection (bilobectomy and pneumonectomy) using echocardiography.

次要结局

  • Post-operative outcome(Within 3rd post-operative day)
  • Post-operative quality of life(3 months, post-operatively)
  • Right ventricle failure(Within 3rd post-operative day)

研究者

发起方
Humanitas Clinical and Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Giustiniano

Principal Investigator

Humanitas Clinical and Research Center

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