NCT02262871

HFN Versus NIV in Cystic Fibrosis. The HIFEN Study

Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	High flow nasal oxygen cannula	HFN will be set with an inspiratory flow rate at 45-55 L/min (maximal tolerated flow), temperature at 37°C or 34°C if perceived as too warm, and fraction on inspired oxygen (FiO2) will be adjusted to achieve an oxygen saturation (SpO2) of at least 92%.
DEVICE	Noninvasive ventilation	The setting of NIV will be appropriately adjusted, based on the clinical assessment of the respiratory therapist in charge and will not be modified during the test.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2017-07-30
• First posted: 2014-10-13
• Last updated: 2018-04-11

Locations

1 site across 1 country: Canada