跳至主要内容
临床试验/NCT04016597
NCT04016597已完成不适用

Comparison of Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults

University of Zurich1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)

研究概览

简要总结

The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices.

The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO).

  1. "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
  2. "HypAir" ("HA", Medisoft, Dinant, Belgium).

详细描述

In a single-center, crossover study conducted at the University Hospital Zurich, Switzerland, 35 healthy, non-smoking adults (>=18 years) will be invited to perform DLNO measurements in random order using the MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium) devices during one study visit.

The order of the tests on the MasterscreenTM and HypAir devices will be randomly allocated using central randomisation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age 18 years and older

排除标准

  • Previous thoracic surgery
  • Chronic lung disease (e.g., asthma bronchiale, COPD)
  • Forced expiratory volume in 1s and/or forced vital capacity below the lower limit of normal based on spirometry [Quanjer et al. Eur Respir J 2005]
  • Current respiratory infection

结局指标

主要结局

Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)

时间窗: 1 hour

Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

次要结局

  • Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)(1 hour)
  • Difference in inspiratory volume (L)(1 hour)
  • Difference in expired concentrations for nitric oxide (in %)(1 hour)
  • Difference in inspired concentrations for nitric oxide (in %)(1 hour)
  • Difference in inspired concentrations for carbon monoxide (in %)(1 hour)
  • Difference in expired concentrations for carbon monoxide (in %)(1 hour)
  • Difference in inspired concentrations for oxygen (%)(1 hour)
  • Difference in breath-hold time (s)(1 hour)
  • Difference in expired concentrations for oxygen (%)(1 hour)
  • Difference in Alveolar volume (L)(1 hour)
  • Difference in inspired concentrations for helium (%)(1 hour)
  • Difference in expired concentrations for helium (%)(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验