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Non‐invasive ventilation versus oxygen therapy in cystic fibrosis: A 12‐month randomized trial
Author(s) -
Milross Maree A.,
Piper Amanda J.,
Dwyer Tiffany J.,
Wong Keith,
Bell Scott C.,
Bye Peter T.P.
Publication year - 2019
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/resp.13604
Subject(s) - medicine , oxygen therapy , spirometry , randomized controlled trial , lung transplantation , cystic fibrosis , quality of life (healthcare) , ventilation (architecture) , hypercapnia , transplantation , anesthesia , respiratory system , asthma , mechanical engineering , nursing , engineering
ABSTRACT Background and objective No published studies have examined the long‐term effects of non‐invasive ventilation (NIV) in cystic fibrosis (CF). Our primary aim was to determine if adults with CF and sleep desaturation were less likely to develop hypercapnia with NIV ± O 2 compared to low‐flow oxygen therapy (LFO 2 ) or meet the criteria for failure of therapy over 12 months. We studied event‐free survival, hospitalizations, lung function, arterial blood gases (ABG), sleep quality and health‐related quality of life. Methods A prospective, randomized, parallel group study in adult patients with CF and sleep desaturation was conducted, comparing 12 months of NIV ± O 2 to LFO 2 . Event‐free survival was defined as participants without events. Events included: failure of therapy with PaCO 2 > 60 mm Hg, or increase in PaCO 2 > 10 mm Hg from baseline, increases in TcCO 2 > 10 mm Hg, lung transplantation or death. Outcomes were measured at baseline, 3, 6 and 12 months, including lung function, ABG, Pittsburgh Sleep Quality Inventory (PSQI), SF36 and hospitalizations. Results A total of 29 patients were randomized to NIV ± O 2 ( n = 14) or LFO 2 ( n = 15) therapy for 12 months. Of the 29 patients, 18 met the criteria for event‐free survival over 12 months. NIV ± O 2 group had 33% (95% CI: 5–58%) and 46% (95% CI: 10–68%) more event‐free survival at 3 and 12 months than LFO 2 group. No statistically significant differences were seen in spirometry, ABG, questionnaires or hospitalizations. Conclusion NIV ± O 2 during sleep increases event‐free survival over 12 months in adults with CF. Further studies are required to determine which subgroups benefit the most from NIV.