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临床试验/NCT04680351
NCT04680351Unknown不适用

Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
2
主要终点
measurement of integral time speed by cardiac transthoracic ultrasound

研究概览

简要总结

Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Mechanical ventilation also has effects on the diaphragm: diaphragmatic dysfunction. It is explained by a prolonged inactivity of this muscle with a reduction of muscle fibers that can settle down quickly, after only a few days of mechanical ventilation. This dysfunction results in a reduction in the latter's ability to generate intrathoracic pressure necessary for ventilation, slows the withdrawal of mechanical ventilation and lengthens the duration of stay in intensive care unit. To reduce this dysfunction, phrenic stimulation has been proposed as an alternative to remuscler the diaphragm thanks to electrodes located on a central venous catheter, also used to deliver the usual therapies in intensive care unit.

The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.

研究设计

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

  • •Patient included in RESCUE 3 study, interventional arm with phrenic stimulation
  • •Patient or family consent

排除标准

  • •Patient not affiliated or not benefiting from a social security scheme

研究组 & 干预措施

phrenic stimulation

Experimental

干预措施: phrenic stimulation (Procedure)

结局指标

主要结局

measurement of integral time speed by cardiac transthoracic ultrasound

时间窗: 1 minute

to assess the effects of phrenic stimulation on cardiac output

Measurement of increased venous return gradient in percentage (variation between the value before phrenic stimulation and the value after phrenic stimulation)

时间窗: 1 minute

To specify the mechanisms of the effect of phrenic stimulation on cardiac output

次要结局

  • variation in ventilation distribution before and after phrenic stimulation measured in electrical impedance tomography(1 minute)
  • Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique(1 minute)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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