跳至主要内容
临床试验/NCT03032900
NCT03032900终止不适用

Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
110
试验地点
1
主要终点
Right ventricular dysfunction

研究概览

简要总结

This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.

详细描述

Few clinical trial studied the incidence of right ventricular dysfunction after major lung resection and time frame of occurrence.

In this prospective observational study the right ventricular function will be mesure with echocardiographic criteria. Echocardiographic exam will be standardised and be realised day before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery.

In order to assess prognostic value of right dysfunction after lung resection, data as hospitalization stay, complications and survival will be collected at 6 months.

Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical finding and other echocardiographic measurements.

研究设计

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

入排标准

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

入选标准

  • •Written consent
  • •Patient older than 18 years
  • •Major lung surgery (pneumonectomy, lobectomy)

排除标准

  • •Pre-existing pulmonary arteria hypertension
  • •Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery)
  • •Technical difficulty preventing adequate echocardiographic assessment
  • •Patient refusal

结局指标

主要结局

Right ventricular dysfunction

时间窗: 5 days

Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS \> 35mmHg or right ventricular dilatation or right systolic markers abnormalities.

次要结局

  • Risk factors(5 days)
  • Time frame to right ventricular dysfunction(5 days)
  • Assessment of 2D strain for right ventricular dysfunctio(5 days)
  • Estimate impact of right ventricular dysfunction on patient prognosis.(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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