HFN Versus NIV in Cystic Fibrosis. The HIFEN Study
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|ClinicalTrials.gov Identifier: NCT02262871|
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: High flow nasal oxygen cannula Device: Noninvasive ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||July 30, 2017|
Experimental: CF patients HFN
CF patients who meet the eligibility criteria will be randomized to receive HFN and then crossover to other device.
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%.
Experimental: CF patients NIV
CF patients who meet the eligibility criteria will be randomized to receive NIV and then crossover to other device.
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.
- The decrease of diaphragmatic workload (thickening fraction of the diaphragm) [ Time Frame: 30 minutes ]
- Respiratory parameters [ Time Frame: 30 minutes ]respiratory rate (RR), minute ventilation
- Gas exchange [ Time Frame: 30 minutes ]pulse oximetry, transcutaneous carbon dioxide partial pressure (PCO2)
- Electromyographic activity of the diaphragm [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262871
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Laurent Brochard, Dr.||St. Michael's Hospital, Toronto|