跳至主要内容
临床试验/NCT03085537
NCT03085537已完成不适用

Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.

Corporacion Parc Tauli3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016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
发起方
入组人数
40
试验地点
3
主要终点
Asynchronies Index

研究概览

简要总结

The main objective will be to determine the effectiveness of home non-invasive ventilation by flow-time and time-pressure curves analysis in a cohort of patients with this treatment by digital diagnosis platform.

详细描述

A multicenter study with observational prospective design will be implemented on 3 spanish hospitals in Barcelona. Inclusion criteria will be equivalent sample size of patients with restrictive lung disease, neuromuscular pathology and hypoventilation-obesity.

Digital diagnosis platform will be used to incorporate and unify signals of different medical devices: a pneumotachograph on branch ventilator that captures pressure and flow-time signals, inductance plethysmography used to like a patient effort sensor and portable pulse oximeter recordings. Nocturnal polygraphic or polysomnographic tracings performed and recorded on sites will be processed systematically by main asynchronies diagnosis algorithms between patient and ventilator. These algorithms providing global and fractionated asynchronies count based on time, leaks or saturation criteria which will be used to compared effective ventilation phases and phases with nocturnal desaturations. Therefore, prevalence and asynchronies model on home NIV can be determine establishing the correlation between desaturation phases and respiratory events and identifying minimum tolerable leak level to keep adequate ventilation.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Home non-invasive mechanical ventilation and clinical stability at least of 6 months ( no acute episode with admission on 2 months before)
  • Mean Ventilator compliance > 4 h/ per night on screening visit
  • Signed informed consent form previously

排除标准

  • Ventilation with oxygen join system.

结局指标

主要结局

Asynchronies Index

时间窗: One week after screening visit if the subject comply inclusion criteria. Asynchronies analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night

Number of respiratory events registered automatically by digital diagnosis platform

次要结局

  • Demographics parameters- age(screening visit)
  • Demographics parameters- sex(screening visit)
  • PaCO2(screening visit)
  • Pittsburgh Sleep Quality Index. (PSQI)(screening visit)
  • Mode Ventilator(recorded date on screening visit)
  • Interfaces(recorded date on screening visit)
  • Tube(recorded date on screening visit)
  • Antyrebreathing system(recorded date on screening visit)
  • Leaks(One week after screening visit if the subject comply inclusion criteria. leaks analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night)
  • Oxygen saturation(One week after screening visit if the subject comply inclusion criteria. Oxygen saturation analysis will be performed once by nocturnal polygraphy once (cross-sectional design) on site during one night)
  • Pathology indication(screening visit)
  • Compliance ventilator(recorded date on screening visit)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manel Lujan-Torne

Lung specialist doctor

Corporacion Parc Tauli

研究点 (3)

Loading locations...

相似试验