Multimodal Measurement of Respiratory Muscle Strength by Using Volitional and Non-volitional Tests in Patients With Obesity Hypoventilation Syndrome (OHS), Obesity-associated Hypoventilation and OHS-Risk-Patients to Evaluate Pathophysiological Determinants and Predictors for the Presence of a Sleep-related Hypoventilation Requiring Treatment in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- transdiaphragmatic pressure (non-volitional)
研究概览
简要总结
Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to
- identify potential determinants for the development of obesity hypoventilation
- to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with BMI > 30 and obesity-associated hypoventilation stages I - IV
- •patients with BMI > 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia)
- •age:18-80 years
- •capacity to consent
排除标准
- •any other disease, that causes ventilatory insufficiency
- •pacemaker, defibrillators or device for deep brain or vagus nerve stimulation
- •esophagitis, Barrett-esophagus, esophageal cancer
- •acute gastritis and ulcera ventriculi
- •any medical, psychological or other condition impairing the patient's ability to provide informed consent
结局指标
主要结局
transdiaphragmatic pressure (non-volitional)
时间窗: 1 day
difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves
diaphragmal ultrasound - thickness (non-volitional)
时间窗: 1 day
thickness of the diaphragm
P0.1 (volitional)
时间窗: 1 day
mouth occlusion pressure (kPa)
peripheral nervous system (non-volitional)
时间窗: 1 day
electroneurography after posterior magnetic stimulation of the phrenic nerves
Carbon dioxide rebreathing test
时间窗: 1 day
minute volumen (L/min)
diaphragmal ultrasound - excursion (non-volitional)
时间窗: 1 day
excursion of the diaphragm
PImax (volitional)
时间窗: 1 day
maximal inspiratory mouth pressure (kPa)
次要结局
- Comparison of PImax and transdiaphragmatic pressure(1 day)