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临床试验/NCT05393115
NCT05393115Unknown不适用

Does Inspiratory Pressure Wave Form Influence Respiratory Muscle Fatigue and Metabolism During Resistive Breathing

Aalborg University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
2
主要终点
Time to task failure (Tlim)

研究概览

简要总结

The study aims at investigating if time to respiratory muscle fatigue and metabolism are influenced by the pressure wave form mode applied during resistive breathing.

详细描述

In healthy subjects fitted with a nasogastric double balloon catheter and breathing at a resistance, the investigators will measure time to failure, Borg ratings, VO2, VCO2, flow, esophageal-, gastric- and airway-pressure. This will be done during breathing at either a square wave or triangle wave pressure waveform, in random order and trials separated by >two days. Further respiratory muscle fatigue will be investigated pre and post intervention by maximal esophageal pressure generation (voluntary and with cervical magnetic stimulation).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

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 men or women
  • Age ≥18 and ≤60 years
  • BMI ≥ 20 and ≤30

排除标准

  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous and present neurologic (e.g. ataxia), musculoskeletal (e.g. muscular dystrophy) or mental illnesses (e.g. schizophrenia)
  • History of mechanical ventilation, COVID-19 with respiratory complications, lung cancer
  • Part of lung resected
  • Presence of dyspepsia/heart-burn/abdominal pain
  • Presence of esophageal varices
  • Presence of liver disease
  • Presence of esophageal hernia
  • Pregnancy
  • Failure to comply with transcranial magnetic stimulation adult safety screen
  • History of epilepsy, metal implants in head or jaw
  • Acute or chronic lung diseases, e.g. asthma, COPD, bronchitis etc.
  • Lack of ability to cooperate

结局指标

主要结局

Time to task failure (Tlim)

时间窗: Up to two months between the two different breathing trials (randomized order)

The time (s) from the subject starts to breathe under the experimental condition, and until task failure will be measured. Task failure is defied by either subject intolerance to continue or by lacking ability of the subject to maintain the target pressure and/or timing. From a previous publication (Bellemare and Grassino, JAP, 1982), it is estimated that subjects will reach Tlim between 30min to 1 hour. If breathing is continued after 1 hour, task failure will not happen as breathing can be continued indefinitely.

次要结局

  • Tidal volume(Up to two months between the two different breathing trials (randomized order))
  • Minute ventilation(Up to two months between the two different breathing trials (randomized order))
  • Respiratory work(Up to two months between the two different breathing trials (randomized order))
  • Insp. and expiratory time(Up to two months between the two different breathing trials (randomized order))
  • Respiratory muscle pressures(Up to two months between the two different breathing trials (randomized order))
  • Metabolism(Up to two months between the two different breathing trials (randomized order))
  • Respiratory rate(Up to two months between the two different breathing trials (randomized order))
  • Ratings of perceived exertion(Up to two months between the two different breathing trials (randomized order))

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathias Krogh Poulsen

Teaching Associate Professor

Aalborg University

研究点 (2)

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