Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study
Brief Summary: 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.


Options:
A: Arm Label: CF patients HFN; Type: EXPERIMENTAL; Interventions: Device: High flow nasal oxygen cannula | Arm Label: CF patients NIV; Type: EXPERIMENTAL; Interventions: Device: Noninvasive ventilation | Intervention Type: DEVICE; Name: High flow nasal oxygen cannula; Assigned to Arm(s): CF patients HFN | Intervention Type: DEVICE; Name: Noninvasive ventilation; Assigned to Arm(s): CF patients NIV
B: Arm Label: High-flow nasal cannula oxygen (HFNCO); Type: EXPERIMENTAL; Interventions: Device: High-flow Nasal Cannula Oxygen (HFNCO) | Arm Label: standard oxygen therapy; Type: ACTIVE_COMPARATOR; Interventions: Device: Conventional oxygen treatment | Intervention Type: DEVICE; Name: High-flow Nasal Cannula Oxygen (HFNCO); Assigned to Arm(s): High-flow nasal cannula oxygen (HFNCO) | Intervention Type: DEVICE; Name: Conventional oxygen treatment; Assigned to Arm(s): standard oxygen therapy
C: Arm Label: Venturi group; Type: ACTIVE_COMPARATOR; Interventions: Device: Venturi mask, Drug: Oxygen | Arm Label: HFNC group; Type: EXPERIMENTAL; Interventions: Device: High Flow Nasal Canula (HFNC), Drug: Oxygen | Intervention Type: DEVICE; Name: High Flow Nasal Canula (HFNC); Assigned to Arm(s): HFNC group | Intervention Type: DEVICE; Name: Venturi mask; Assigned to Arm(s): Venturi group | Intervention Type: DRUG; Name: Oxygen; Assigned to Arm(s): HFNC group, Venturi group
D: Arm Label: HFNT; Type: EXPERIMENTAL; Interventions: Other: HFNT | Arm Label: NIV; Type: ACTIVE_COMPARATOR; Interventions: Other: NIV | Intervention Type: OTHER; Name: HFNT; Assigned to Arm(s): HFNT | Intervention Type: OTHER; Name: NIV; Assigned to Arm(s): NIV

Answer: A