Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The decrease of diaphragmatic workload (thickening fraction of the diaphragm)
研究概览
简要总结
Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit (ICU) admission because of acute exacerbation of chronic respiratory failure or for any acute deterioration of clinical status. Non-invasive ventilation (NIV) is the first option for the clinical management of CF patients with moderate-to-severe respiratory distress and NIV has been shown to improve gas exchange, reduce respiratory muscle work and improve pulmonary function in patients with obstructive lung disease in general and those with acute CF exacerbation. High-flow nasal oxygen cannula (HFN) is a relatively new system providing heated and humidified, high-flow (50L/min) oxygen through the nostrils. This device provides a small positive pressure, probably washes-out the pharyngeal dead space, reduces inspiratory resistance, and possibly facilitates secretion clearance. The technique is very well tolerated. From a physiologic standpoint, this device could help CF patients by improving gas exchange, reducing respiratory workload, and facilitating mucus clearance. Non-interrupted delivery may be possible given better clinical tolerance in contrast with bi-level positive pressure NIV. Whether the short-term physiological efficacy of HFN is comparable to NIV is unknown and there is no study on the benefit of HFN in CF patients.
The aim of this study is to compare the physiological effects of HFN and NIV in CF patients requiring ventilatory support. Our hypothesis is that HFN will not be inferior to NIV, as evaluated by breathing pattern, gas exchange, and respiratory workload and will decrease dead space. In addition, comfort and preference between the two techniques will be evaluated.
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
- 否
入选标准
- •Age ≥ 18 years
- •Cystic fibrosis as defined by clinical features in conjunction with 2 CF causing mutations and/or 2 sweat tests with sweat chloride > 60 mmol/l
- •Clinical indication for NIV based on at least one of the following criteria:
- •Signs of clinical respiratory distress - RR > 24/min, accessory muscle use, or increased dyspnea
- •Progressive increase in arterial PCO2
- •Nocturnal hypoventilation treated by NIV but requiring daytime NIV because of clinical worsening
排除标准
- •Active massive hemoptysis
- •Pneumothorax with pleural drainage and persistent air leak
- •Hemodynamic instability requiring vasopressors
- •Uncooperative
- •Recent upper airway or esophageal surgery
- •Patients with skin or chest wall or abdominal trauma
研究组 & 干预措施
CF patients HFN
CF patients who meet the eligibility criteria will be randomized to receive HFN and then crossover to other device.
干预措施: High flow nasal oxygen cannula (Device)
CF patients NIV
CF patients who meet the eligibility criteria will be randomized to receive NIV and then crossover to other device.
干预措施: Noninvasive ventilation (Device)
结局指标
主要结局
The decrease of diaphragmatic workload (thickening fraction of the diaphragm)
时间窗: 30 minutes
次要结局
- Electromyographic activity of the diaphragm(30 minutes)
- Respiratory parameters(30 minutes)
- Gas exchange(30 minutes)
