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临床试验/NCT01671540
NCT01671540Unknown不适用

Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Lung function testing

研究概览

简要总结

In this study the invetigators seek an answer on the following hypothesis:

  • What are the long term effects of an IPV treatment evaluated with classical outcome parameters? (FEV1, Raw)
  • Is the possible effect noticeable on the novel technique and is this comparable with the classical outcome parameters?

详细描述

A Multicenter study conducted in university Hospital Antwerp (UZA) and ZNA Middelheim.

Tests are taken before and after one week IPV treatment. IPV is applied for 1 week during the physical therapy treatment of chronic obstructive pulmonary desease (COPD) patients admitted to the hospital for an excarebation. The IPV treatment is an additional treatment upon the standard treatment of the patients. The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises. Patients are randomized into either the experimental group or the control group. The control group receives a standard physical therapy treatment without additional IPV treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • •Patients admitted in the hospital for a acute exacerbation
  • •Mild to severe COPD

排除标准

  • •Ischemic / ventricular aritmic
  • •Tracheotomise
  • •Pneumothorax
  • •Facial deformity
  • •Recent nose, mouth or ear operations
  • •Recent gastric operations.
  • •Intubated

研究组 & 干预措施

Intrapulmonary percussive ventilation

Experimental

IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient

干预措施: intrapulmonary percussive ventilation (Device)

standard airwy claerance regime

Active Comparator

The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises

干预措施: standard treatment (Other)

结局指标

主要结局

Lung function testing

时间窗: baseline and after one week

(spirometric , bodybox en diffusion) Performed in the lung function laboratory according to ERS standards using Jaeger 5.1 device vital capacity (VC), FEV1, FEV1/VC, peak expiratory flow (PEF), MMEF 75/25, MEF 50, MEF 25, MIF 50, RV, total lung capacity (TLC), functionale residual capacity (FRC), resistance, spec resistance, TCO, alveolar volume (VA), TCO/VA, Maximal inspiratory pressure, Maximal expiratory pressure

次要结局

  • functional respiratory imaging(at baseline and after one week)

研究者

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

Wilfried De Backer

Prof. Dr.

University Hospital, Antwerp

研究点 (1)

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