HFN Versus NIV in Cystic Fibrosis. The HIFEN Study

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Noninvasive ventilation; Device: High flow nasal oxygen cannula

• Registration Number: NCT02262871
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-13
• Study Start: 2014-12
• Primary Completion: 2016-12
• Study Completion: 2017-07-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CF patients NIV	Noninvasive ventilation	CF patients who meet the eligibility criteria will be randomized to receive NIV and then crossover to other device.
CF patients HFN	High flow nasal oxygen cannula	CF patients who meet the eligibility criteria will be randomized to receive HFN and then crossover to other device.

Primary Outcome Measures

Name	Time	Method
The decrease of diaphragmatic workload (thickening fraction of the diaphragm)	30 minutes

Secondary Outcome Measures

Name	Time	Method
Respiratory parameters	30 minutes	respiratory rate (RR), minute ventilation
Gas exchange	30 minutes	pulse oximetry, transcutaneous carbon dioxide partial pressure (PCO2)
Electromyographic activity of the diaphragm	30 minutes

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada