Status:
COMPLETED
HFN Versus NIV in Cystic Fibrosis. The HIFEN Study
Lead Sponsor:
Unity Health Toronto
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02262871
Start Date
December 1 2014
End Date
July 30 2017
Last Update
April 11 2018
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8