跳至主要内容
临床试验/NCT03179644
NCT03179644已完成不适用

Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Pleural pressure

研究概览

简要总结

The primary objective of the study is to determine the correlation between mean pleural pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation.

In this research, oesophageal pressure will be measured by a nasogastric tube with an esophageal balloon (also suitable for feeding the patient) usually installed at the time of transplantation, pleural pressure will be measured by several Pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the surgery without additional skin intrusion.

详细描述

Pulmonary transplantation is a model of acute lung injury due to ischemia-reperfusion phenomena responsible in 1 in 4 patients for the occurrence of primary graft dysfunction (DPG), which penalizes graft prognosis in the short to medium term. The survival of transplant patients. Furthermore, the post-operative period is a complex period in which multiple hemorrhagic, immunological, infectious, and neuromuscular complications may arise that may require prolonged mechanical ventilation. At present, there are no data on the measurement of pressure in pleural space after pulmonary transplantation. Achieving this measurement would make it possible to adapt the settings of the ventilator to both the acute phase in the case of DPG and to a later phase in case of mechanical weaning. In the case of bi-pulmonary transplantation, before the thorax is closed, each patient benefits from the systematic placement of bilateral anterior and posterior thoracic drains to prevent the formation of fluid effusions (hemothorax, pleurisy) and / or gases (pneumothorax ) Which would impede ventilation and compromise gas exchange. These drains are gradually withdrawn during resuscitation usually after weaning mechanical ventilation

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Adult patient admitted in the Respiratory Distress and Severe Infections Intensive Care Unit in the postoperative period following a double lung transplant after written informed consent.

排除标准

  • Age less than 18 years, Pregnancy, breast feeding, adults under guardianship or under safeguard justice, not beneficiaries of a social security scheme, persons deprived of liberty by a judicial or administrative decision , those hospitalized without consent Single lung transplant
  • Open chest at the end of transplantation
  • high flow pleura-pulmonary fistula (Contraindication to the establishment of a nasogastric tube proven presence of esophageal varices esophageal tumor Surgery of the esophagus of less than 1 year

结局指标

主要结局

Pleural pressure

时间窗: 5 days

The pleural pressure will be measured using several pleurocath-type catheters (Prodimed Inc, France)(4 inspiratory measures and 4 expiratory measures)

Oesophageal pressure

时间窗: 5 days

The oesophageal pressure will be measured with a nasogastric tube with an esophageal balloon (also enabling the patient to be fed)(6 measurements at the end of inspiration and 6 at the end of expiration).

次要结局

  • Correlations between the mean pleural pressure and esophageal pressure during the 5 days following a double lung transplant.(5 days)
  • Comparison between the pleural pressure and esophageal pressure depending on the lung injury, the ventilation mode and the body position (supine and prone position)(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验