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Trial record 10 of 10 for:    25003980 [PUBMED-IDS]

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
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: High flow nasal oxygen cannula Device: Noninvasive ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The decrease of diaphragmatic workload (thickening fraction of the diaphragm) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Respiratory parameters [ Time Frame: 30 minutes ]
    respiratory rate (RR), minute ventilation

  2. Gas exchange [ Time Frame: 30 minutes ]
    pulse oximetry, transcutaneous carbon dioxide partial pressure (PCO2)

  3. Electromyographic activity of the diaphragm [ Time Frame: 30 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Laurent Brochard, Dr. St. Michael's Hospital, Toronto

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02262871     History of Changes
Other Study ID Numbers: REB14-338
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by St. Michael's Hospital, Toronto:
Cystic fibrosis
High-flow nasal oxygen cannula
Non-invasive ventilation
Respiratory distress
Oxygen therapy
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases