Unloading of the Respiratory Muscles Using Non-invasive Neurally Adjusted Ventilatory Assist in Healthy, Resistively Loaded Volunteers

Insel Gruppe AG, University Hospital Bern2 个研究点分布在 1 个国家目标入组 16 人开始时间: 2009年7月最近更新: 2010年2月5日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Insel Gruppe AG, University Hospital Bern
入组人数: 16
试验地点: 2
主要终点: changes in mean inspiratory airway pressure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in respiratory muscle unloading in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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: 是

入选标准

•Subject has given written informed consent.
•Male or female, aged 18 - 80 years (extremes included).

排除标准

•Pregnant or breast-feeding female. A pregnancy test will be performed in all female volunteers less than 60 yrs of age.
•Known intolerance or allergy against local anesthetic drugs such as procain, lidoocaine, xylocain.
•Any contraindication to the insertion of a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture, bleeding disorder with evidence of active bleeding.
•Presence or suspicion of diaphragm injury.
•Prior medical history that might contribute to a disturbance of the neural system, including, but not limited to: diabetes, prior critical illness, carcinoma, uremia, vitamin B12 deficiency, chronic liver disease, alcohol abuse, malabsorption (sprue), HIV, Lyme disease, Lymphoma, multiple myeloma, hypothyroidism, systemic vasculitis, abnormalities on physical examination of peripheral nervous system (pallesthesia, impaired muscle strength according to the MRC Scale for Muscle Examination in 12 Muscle groups).

结局指标

主要结局

changes in mean inspiratory airway pressure

时间窗: beginning to end of study

次要结局

changes in respiratory pattern(begin to end of study)

研究者

发起方

Insel Gruppe AG, University Hospital Bern

申办方类型

Other

研究点 (2)

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