Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantation
研究概览
简要总结
The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.
Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.
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
- 否
入选标准
- •Adult (over 18 years)
- •Patient affiliated to a social protection scheme insurance
- •Patient was informed of the study and w gave their consent
- •Patient on the lung transplant list
- •Patient eligible for a pulmonary transplantation after decision of a multidisciplinary team
- •Patients with chronic lung disease with parenchymal dysfunctions (Chronic obstructive pulmonary disease or COPD, alpha-1 antitrypsin deficiency, cystic fibrosis, pulmonary fibrosis, bronchiolitis obliterans organizing pneumonia or BOOP)
排除标准
- •Minor patients
- •Patient under judicial protection, under guardianship
- •Patient in exclusion period (determined by a previous study or in progress)
- •Patient participating in parallel in another clinical trial that may interfere with the results of the study
- •Inability to give informed patient information (emergency, understanding difficulties, etc ...)
- •The refusal of patient consent
- •The use of cardiopulmonary bypass during lung transplantation
- •Uni-pulmonary transplant
- •A transplant for idiopathic or primary pulmonary hypertension
- •The presence of a cons-indication for transesophageal echocardiography:
- •o Absolute contraindications:
- •Abnormalities of the esophagus: stenosis, tumor, diverticulum perforation, active bleeding
- •o Relative contraindications:
- •ancient cervicothoracic irradiation history (> 10 years)
- •recent upper gastrointestinal bleeding history
- •presence of esophageal varices ≥ grade II
- •zero cervical mobility
- •Reflux Esophagitis
- •Severe coagulation disorders
- •Pregnancy / Breastfeeding
结局指标
主要结局
Transesophageal echocardiographic assessment for comparision of right ventricle isovolumic acceleration in perioperative care of bipulmonary transplantation
时间窗: utcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
Transesophageal echocardiographic assessment for comparision of right ventricle free-wall strain rate in perioperative care of bipulmonary transplantation
时间窗: Outcome is measured 3 times : after induction of general anesthesia, before surgical incision, after throacic closure and 6 to 12 hours postoperative.
次要结局
未报告次要终点