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临床试验/NCT02877290
NCT02877290已完成不适用

The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle Tissue, Cardiovascular System and Exercise Capacity in Hypercapnic COPD Patients

Schön Klinik Berchtesgadener Land2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
cycle endurance time

研究概览

简要总结

In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without in a randomized cross-over design. The aim is to measure, whether NIV is able to change peripheral and respiratory muscle oxygenation.

详细描述

In this study patients will perform one incremental work rate test to obtain peak work rate. On the following days two constant work rate cycle endurance tests (CWRT) will be performed at 60% of Peak work rate using a randomised cross-over design. Between the two CWRTs there will be one hour of recovery time in between.

One of the CWRTs will be performed with the support of non-invasive Ventilation (NIV), the other one without. Respiratory and cardiovascular parameters will be observed through transcutaneous measurement of CO2 (Sentec device) and near-infrared spectroscopy devices.

The purpose of this study is, to examine whether the use of NIV not only decreases patients dyspnoea, but also has positive effects on the patients cardiovascular System, exercise capacity and muscle oxygenation. The investigators will examine the tissue oxygen saturation in the 7th intercostal space (reflecting a respiratory muscle) and on the M. vastus lateralis of the leg during both CWRTs. With the Support of NIV, it is expected to see a change in the oxygenation towards a better perfusion of the leg muscle, due to a facilitation of the work of breathing. This may result in a later onset of leg fatigue and an increased exercise capacity of the patients. To have an equivalent workload all parameters will be compared during isotime.

To conclude, aim of this study is to record the interplay of Oxygenation and Perfusion between the Intercostal muscles and the peripheral leg muscle during exercise. The investigators hypothesize, that the use of NIV may change the oxygenation in favour of the leg muscle through relieving the respiratory muscles.

研究设计

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

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic obstructive pulmonary disease GOLD (Global initiative for chronic obstructive lung disease) stage IV
  • Hypercapnia: pCO2>50mmHg (at rest or in exercise)
  • written consent

排除标准

  • orthopaedic comorbidities that do not allow a cycle endurance test
  • acute exacerbation of COPD
  • Cardiac insufficiency, acute coronary syndrome

结局指标

主要结局

cycle endurance time

时间窗: maximum 20 minutes

time patient ist able to cycle at 60% of his peak work rate

次要结局

  • Oxygen saturation(30 minutes)
  • Arterial blood pressure(30 minutes)
  • Borg scale of dyspnoea(30 minutes)
  • Heart rate(30 minutes)
  • Borg scale of leg fatigue(30 minutes)
  • arterial carbondioxide partial pressure(30 minutes)
  • total hemoglobin(30 minutes)
  • Tissue Saturation Index(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Klaus Kenn

Prof. Dr. Klaus Kenn

Schön Klinik Berchtesgadener Land

研究点 (2)

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