Status:
UNKNOWN
Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Philips Respironics
Conditions:
Chronic Obstructive Pulmonary Disease
Acute Exacerbation of Chronic Obstructive Airways Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Background: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being sho...
Detailed Description
Background Noninvasive ventilation (NIV) has been shown to improve survival in patients with chronic obstructive pulmonary disease (COPD), admitted with acute hypercapnic respiratory failure (AHRF); a...
Eligibility Criteria
Inclusion
- Patient admitted with a NIV-requiring exacerbation of COPD
- COPD with a FEV1/FVC \<0.7 after bronchodilatation.
- ≥ 1 acute hypercapnic respiratory failure (AHRF \*).
- Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist Tiotropium, according to GOLD guidelines.
- Address in Capital Region
- Patients are able to give verbal consent and sign a written consent form and understand Danish-
Exclusion
- Severely depressed level of consciousness / confusion / non-cooperative.
- Respiratory rate \<12/min
- Severe hypoxia, such as requiring more than 15L O2/min.
- Large amounts of sputum.
- Vomiting and high risk for aspiration.
- Inability to accept NIV.
- Recent abdominal, facial or upper airway surgery.
- Malignancy or life expectancy \<6 months because of disease other than COPD
- Known obstructive sleep apnea syndrome (OSA)
- Metabolic acidotic component - StHCO3- \< 20 mM
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01513655
Start Date
July 1 2013
End Date
July 1 2020
Last Update
November 16 2018
Active Locations (4)
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1
Dept. of Pulmonary Medicine Y, UH Gentofte
Hellerup, Denmark, DK-2900
2
Dept. of Internal Medicine O, UH Herlev
Herlev, Denmark, DK-2730
3
Dept. of Pulmonary Medicine and Cardiology, UH Hvidovre
Hvidovre, Denmark, DK-2650
4
Dept. of Pulmonary Medicine, L, UH Bispebjerg
København NV, Denmark, DK-2400