跳至主要内容
临床试验/NCT02900300
NCT02900300已完成不适用

Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年2月18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
12
试验地点
1
主要终点
Myoblast differentiation capacity

研究概览

简要总结

This non-interventional study focuses on mechanical ventilation used in intensive care unit to supplement ventilatory function in patients. Mechanical ventilation can "paradoxically" be at the origin of complications that can be life-threatening in patients. This muscular pathology is called ventilation-induced diaphragmatic dysfunction (DDIV).

Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved. The diaphragm biopsy from the care will be retained for biobanking to obtain myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.

研究设计

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

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 30 and 65 years old
  • patient treated by the digestive surgery department of Montpellier University Hospital for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm
  • Non-smoker patient for more than 6 months
  • patient clinically stable at the time of the study, ie not requiring any treatment

排除标准

  • Patients undergoing treatment with antibiotics or corticosteroids, or recently within the last 4 months
  • Patients with a body mass index > 30
  • Patients with any criteria that may in themselves impair respiratory muscle function such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology or metabolic disorder.
  • Patients with coagulopathy or thrombocytopenia.

结局指标

主要结局

Myoblast differentiation capacity

时间窗: 24 month

Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress.

次要结局

  • Myoblast proliferation capacity(24 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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