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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02262871 |
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Date of registration:
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07/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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HFN Versus NIV in Cystic Fibrosis. The HIFEN Study
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Scientific title:
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Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02262871 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Laurent Brochard, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Michael's Hospital, Toronto |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Device: High flow nasal oxygen cannula
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Device: Noninvasive ventilation
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Primary Outcome(s)
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The decrease of diaphragmatic workload (thickening fraction of the diaphragm)
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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Electromyographic activity of the diaphragm
[Time Frame: 30 minutes]
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Gas exchange
[Time Frame: 30 minutes]
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Respiratory parameters
[Time Frame: 30 minutes]
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Secondary ID(s)
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REB14-338
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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