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临床试验/NCT05528289
NCT05528289已完成不适用

Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月4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
20
试验地点
2
主要终点
Changes of the partial pressure of carbon dioxide (PaCO2) levels

研究概览

简要总结

High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and respiratory effort.

The aim of this randomized crossover physiological study is to investigate the effects on PaCO2 levels of two different nasal cannula ('Optiflow + Duet' interface vs "standard" nasal interface) in COPD patients with persistent hypercapnia following an acute severe exacerbation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Inpatients recovering from an acute exacerbation of their disease
  • Persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH>7,35 and
  • PaCO2>50 mmHg on 3 consecutive measurements)
  • Informed consent

排除标准

  • Body Mass Index (BMI) > 30 kg/m2;
  • Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
  • Chest wall disease
  • Heart failure
  • Severe hemodynamic instability ( need for amine support)
  • Acute coronary syndrome (ACS)
  • Severe arrhythmia
  • Renal insufficiency
  • Patients unable to protect respiratory airways
  • Respiratory arrest and need for endotracheal intubation
  • Pregnancy
  • Need for sedation

结局指标

主要结局

Changes of the partial pressure of carbon dioxide (PaCO2) levels

时间窗: immediately after intervention

Arterial Blood Gases will be analyzed from a sample taken from the arterial artery

次要结局

  • Dyspnea score(immediately after intervention)
  • Comfort(immediately after intervention)
  • Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)(90 minutes)
  • Minute Ventilation (VE), (L/min)(90 minutes)
  • Inspiratory effort quantification(90 minutes)
  • Respiratory Rate ( RR), (b/min)(90 minutes)
  • Tidal Volume ( TV), (mL)(90 minutes)

研究者

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

dr. Stefano Nava

Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (2)

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