Evolution of Diaphragm Thickness Under Veno-arterial ECMO : Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care.
研究概览
简要总结
The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients.
The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the deterioration of patients' prognosis.
详细描述
The evolution of diaphragm muscle thickness is described in human resuscitation under mechanical ventilation, but the incidence, causes and functional impact have not been studied in patients undergoing cardiopulmonary bypass ECMO (extra-corporeal membrane oxygenation) veno-arterial (VA). More generally, the muscular mechanisms of dyspnea in cases of acute cardiac dysfunction are not known.
The evolution of the diaphragmatic thickness in intensive care has been described during prolonged stay in intensive care and from the initial phase of septic status. It is associated with dyspnea, weaning delay of mechanical ventilation and impact on patient outcomes. The atrophy of the diaphragm muscle is related to both loss of function and loss of muscle performance. The same is true for hypertrophy that is caused by overuse of the muscle and also causes loss of function.
Decreased cardiac muscle performance may require both cardiac assistance and respiratory assistance. Cardiac and respiratory dysfunction may complicate withdrawal of respiratory assistance and extracorporeal circulatory support devices. These two supports, respiratory and circulatory support, make it possible to mitigate the insufficiency of the systemic flow, the oxygenation and the purification of the CO2. Respiratory assistance is known to influence the diaphragmatic function. The role of muscle pump function in the weaning process of the ECMO, however, remains largely unknown.
Ultrasound is used in the patient's bed in daily practice to measure cardiac function, the study of vessels but also the diaphragm muscle. It allows to study the trophicity of the diaphragm and these efforts via its contraction. The hypothesis that there is muscular involvement of the diaphragm in this measurable condition by ultrasound method can be formulated.
No study has systematically explored the existence of diaphragmatic atrophy under VA ECMO. The influence of cardiac and respiratory assistance is not known.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient hospitalized in intensive care
- •Patient under veno-arterial ECMO
- •Non-opposition of the patient or relatives
- •Affiliation to a health insurance
排除标准
- •Subject under guardianship or subject deprived of liberty
- •Pregnant or lactating woman
结局指标
主要结局
To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care.
时间窗: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Evaluation of the trophicity of the diaphragm muscle at the end of the expiration from the first day in the intensive care unit after the ECMO implementation until the D7 of the hospitalization with ultrasound. A change greater than 10% of the thickness will define three groups of patients (loss of thickness, stability and thickness gain). The first day that this value is reached will determine the allocation in one or the other group.
次要结局
- To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7)
- To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7)
- To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm(Day 60)
- To evaluate the evolution of the performance of the diaphragm muscle in patients in intensive care.(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7)
- To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7)
- To evaluate the link between the associated organ failures and the diaphragm evolution in patients in intensive care(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7)