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临床试验/NCT01981915
NCT01981915已完成不适用

Optimum Insufflation Capacity and Peak Cough Flow Augmentation in Patients With Neuromuscular Disease

Universität Duisburg-Essen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1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
40
试验地点
2
主要终点
insufflation capacity

研究概览

简要总结

Patients with underlying neuromuscular disorder (NMD) often suffer from weakness in the inspiratory and expiratory muscles. Consequently they do not have the strength to generate the minimum flow of 160 to 300 liters/minute for an efficient cough function. The restricted cough function allows secretion to accumulate, which in turn causes narrowing of the airway lumen and makes ventilation of the neuromuscular patient even more difficult. The patient's susceptibility to infection increases again and the vicious circle repeats itself. Severe secretion retention may even lead to ventilator failure. Effective secretion and cough management instead reduces the risk for stay in hospital. Therefore, secretion and cough management is a mandatory part of the therapeutic concept for treating patients with neuromuscular disease.

The therapeutic efficacy of the Lung Insufflation Assist Maneuver(LIA) integrated in the ventilator VENTIlogic LS-plus manufactured by Weinmann GmbH+Co KG was studied in a pilot study carried out by the Dep. for Pediatric Pulmonology and Sleep Medicine at the University Hospital of Essen/Germany in cooperation with Research & Development at Weinmann GmbH &Co KG, Germany . The objective of the pilot study was to examine the therapeutic efficacy of LIAM as a cough support function in patients with neuromuscular disease and indications for mechanical ventilation.

We hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve the highest individual peak cough flow and ii) that this pressure is below the pressure needed to achieve the maximum insufflation capacity. We define the lowest insufflation capacity at which the best individual PCF can be achieved as optimum insufflation capacity (OIC). The study was performed using two different techniques in order to demonstrate that findings are not dependent on maneuver details but are rather based on effects of maneuver pressure. The protocol was limited to techniques which do not require breath stacking: i) insufflation with an Intermittend Positive Pressure (IPPB) device and ii) with the VENTIlogic LS using LIAM.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neuromuscular disorder
  • respiratory insufficiency
  • use of home mechanical ventilation

排除标准

  • acute illness
  • history of pneumothorax

结局指标

主要结局

insufflation capacity

时间窗: change of lung volume with the procedure; during hospital stay on average 3 days

Lung volume was measured during spontaneous breathing and after a lung insufflation assist maneuver.

次要结局

  • Peak cough flow(change of peak cough flow with the procedure; during hospital stay on average 3 days)

研究者

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

Uwe Mellies

Priv.-Doz. Dr. med.

Universität Duisburg-Essen

研究点 (2)

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