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临床试验/NCT03736239
NCT03736239已完成不适用

Ultrasound Study of the Diaphragm Evolution Under ECMO

Association Pro-arte1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Evaluate the evolution of the diaphragm muscle effort in cardiogenic shock during the first ECLS weaning in patients in ICU.

研究概览

简要总结

Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients.

详细描述

Diaphragmatic atrophy and diaphragmatic dysfunction are described in human resuscitation under mechanical ventilation, but this diaphragmatic function has not been studied in patients with cardiogenic shock and also under cardiac assistance by extracorporeal circulation called ECLS (Extra -corporeal Life support). Diaphragmatic dysfunction in intensive care has been described during prolonged stay in intensive care and early sepsis. It is associated with dyspnea and delayed weaning from mechanical ventilation. The atrophy of the diaphragm muscle is related to both loss of function and also loss of muscle performance.

Decreases in heart muscle and diaphragm performance may require both cardiac and respiratory assistance. Cardiac and respiratory dysfunctions can complicate the weaning of the respiratory assistance and also extracorporeal circulatory support supports. These two supports, respiratory and circulatory assistance, allow the purification of CO2 and respiratory assistance is known to influence the diaphragmatic function. The role of the muscular pump function in the withdrawal process of the ECLS, remains largely unknown. The aim of our study is to give a description of the physiology of the diaphragm in case of cardiogenic shock: we want to evaluate the force of the diaphragm according to the ventilation under ECLS. No studies have yet evaluated the influence of ECLS as a CO2 purification system on the performance of the diaphragm muscle.

Ultrasound is used in the patient's bed in daily practice to measure cardiac function, vessel study and diaphragm muscle. This method is reproducible and non-invasive. It can be hypothesized that there is a muscular involvement of the diaphragm under extracorporeal membrane oxygenation (ECMO) measurable by ultrasound method. Our main hypothesis is that the diaphragm force evolves according to the cleaning of the CO2 by the ECLS during the weaning of this one.

This is a Monocentric Prospective Observational Descriptive study. The objective of this study is to evaluate prospectively and consecutively the evolution of diaphragmatic muscle stress in cardiogenic shock with ultrasounds during the first ECMO weaning in intensive care patients.

When cardiogenic shock occurs, during the first ECLS weaning, we also will evaluate prospectively :

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 for cardiogenic shock under ECMO (extracorporeal membrane oxygenator)
  • •Veno-arterial ECMO
  • •ECMO withdrawal decision
  • •Patient or family agreeing to participate in research

排除标准

  • •Patient under guardianship or curatorship
  • •Contraindication to spontaneous ventilation
  • •Pregnant woman
  • •Anechoic patient for diaphragmatic ultrasound

结局指标

主要结局

Evaluate the evolution of the diaphragm muscle effort in cardiogenic shock during the first ECLS weaning in patients in ICU.

时间窗: at 15 min

The performance of the diaphragm muscle will be evaluated by ultrasonography (the thickening fraction of the diaphragm) during the weaning of the ECMO at different weaning level : after 15 minutes (Baseline, 4 l/min, 2 l / min, 1 l / min). Wash out of 10 min between each measurement. The parameters of the assisted ventilation will be standardized according to the practices of the service and recommendations.

次要结局

  • Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of diaphragm muscle thickness(at 15 min)
  • Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of the function of the diaphragm muscle(at 15 min)
  • Evaluate the impact of different risk factors on the diaphragmatic function(previous exposure before inclusion)
  • Evaluate the impact of the diaphragmatic function on the patient's future: failure to wean from mechanical ventilation(at 60 days)
  • Evaluate the impact of the diaphragmatic function on the patient's future: ECLS weaning failure(at 60 days)
  • Evaluate the impact of the diaphragmatic function on the patient's future: Death in intensive care(at 60 days)
  • Evaluate the impact of the diaphragmatic function on the patient's future: Length of stay in intensive care(at 60 days)

研究者

发起方
Association Pro-arte
申办方类型
Other
责任方
Sponsor

研究点 (1)

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