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临床试验/NCT06046898
NCT06046898已完成不适用

Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年11月6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
10
试验地点
2
主要终点
Accuracy of sMMG to detect respiratory effort

研究概览

简要总结

Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Crossover
主要目的
Device Feasibility
盲法
Single (Outcomes Assessor)

盲法说明

Recordings will be analysed by investigators blind to ventilation conditions

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteer
  • Age > 18 and < 60
  • Informed consent
  • Subjects covered by or having the rights to medical care assurance

排除标准

  • Obesity (BMI > 30 kg.m-2)
  • Respiratory disease
  • Cardiovascular disease
  • Contraindication to the insertion of a nasogastric tube
  • Incapacity to consent
  • Pregnancy, breastfeeding
  • Bad understanding of the French language,
  • Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act.

结局指标

主要结局

Accuracy of sMMG to detect respiratory effort

时间窗: 5 minutes after the beginning of recording

Delays between the beginning of the respiratory effort detected by sMMG and Eadi and the end of the respiratory effort detected by sMMG and Eadi (msec)

次要结局

  • Comparison between sMMG slope & Eadi parameters(5 minutes after the beginning of recording)
  • Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak(5 minutes after the beginning of recording)
  • Comparison between sMMG slope & slope Peso(5 minutes after the beginning of recording)
  • Delay between neural time measured by sMMG and neural time measured by Eadi(5 minutes after the beginning of recording)

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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