Status:
COMPLETED
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Monash University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether correction of low nighttime oxygen (O2) levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their quality of life. The...
Detailed Description
Cystic fibrosis is the commonest life-limiting genetic disorder in the Caucasian population with a median survival of 31 years. Lung disease is responsible for the majority of morbidity and mortality ...
Eligibility Criteria
Inclusion
- proven diagnosis cystic fibrosis, age 18 years or older, FEV1\< 70% predicted normal, clinically stable (no admission or antibiotics last 2 weeks, OR end of admission where further clinical improvement not expected), nocturnal respiratory failure (SpO2\<90% for \> 10% of night or rise in PtcCO2 \> 5 mmHg in REM), daytime hypercapnia (PaCO2\> 45 mmHg)
Exclusion
- Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological disease likely to compromise ventilatory control
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00157183
Start Date
March 1 2003
End Date
March 1 2006
Last Update
December 5 2013
Active Locations (1)
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1
The Alfred
Melbourne, Victoria, Australia, 3181