跳至主要内容
临床试验/NL-OMON48829
NL-OMON48829招募中4 期

octurnal Non-Invasive ventilation in COPD patients with stable hypercapnic respiratory failure: why and in which patient might this be effective? - The effects of nocturnal non-invasive ventilation in stable COPD patients

niversitair Medisch Centrum Groningen0 个研究点目标入组 86 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
86

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced expiratory volume (FVC)< 70% and FEV1< 50% predicted; PaCO2 > 6.0 kilopascal (kPa) in stable condition, which means no COPD exacerbation for 4 weeks and a pH > 7.35)
  • Shared consent of the participant and agreement of the participant and his/her home mechanical ventilation centre doctor to start NIV
  • Age > 18 years
  • Written informed consent is obtained

排除标准

  • For inclusion in the prospective cohort part of the study no special exclusion criteria exist. ;For the randomised inflammation part, in which patients will undergo bronchoscopies, a potential subject who meets any of the following criteria will be excluded from participation in this study:;• The use of >10mg oral corticosteroids or roflumilast in any dosage
  • A history of lung volume reduction surgery
  • Body mass index (BMI) > 35 kg/m2
  • Obstructive sleep apnoea (OSA) (apnoea/hypopnea index (AHI) >15/hr): to exclude OSA a polygraphy will be done at baseline
  • PaCO2 >= 8.0 kPa or PaO2 < 6.5 kPa at rest without oxygen
  • Instable cardiac comorbidities (left ventricular ejection fraction (LVEF)<40%, instable coronary artery disease, instable heart failure)

研究者

相似试验