Jens Bräunlich 1 , Dominic Dellweg 2 , Andreas Bastian 3 , Stephan Budweiser 4 , Winfried Randerath 5 , Dora Triché 6 , Martin Bachmann 7 , Christian Kähler 8 , Abdel Hakim Bayarassou 9 , Irmhild Mäder 10 , Jens Geiseler 11 , Norbert Köhler 12 , David Petroff 12 , Hubert Wirtz 1
05 July 2019
Despite the encouraging results of noninvasive ventilation (NIV) in chronic hypercapnic COPD patients, it is also evident that some patients do not tolerate NIV or do not benefit from it. We conducted a study in which COPD patients with stable, chronic hypercapnia were treated with NIV and nasal high-flow (NHF) to compare effectiveness.
In a multi-centered, randomized, controlled, cross-over design, patients received 6 weeks of NHF ventilation followed by 6 weeks of NIV ventilation or vice-versa (TIBICO) between 2011 and 2016. COPD patients with stable daytime hypercapnia (pCO 2≥50 mmHg) were recruited from 13 German centers. The primary endpoint was pCO 2 changes from baseline blood gas, lung function, quality of life (QoL), the 6 min walking test, and duration of device use were secondary endpoints.
A total of 102 patients (mean±SD) age 65.3±9.3 years, 61% females, body mass index 23.1±4.8 kg/m 2, 90% GOLD D, pCO 2 56.5±5.4 mmHg were randomized. PCO 2 levels decreased by 4.7% (n=94; full analysis set; 95% CI 1.8–7.5, P=0.002) using NHF and 7.1% (95% CI 4.1–10.1, P<0.001) from baseline using NIV (indistinguishable to intention-to-treat analysis). The difference of pCO 2 changes between the two devices was −1.4 mmHg (95% CI −3.1–0.4, P=0.12). Both devices had positive impact on blood gases and respiratory scores (St. George’s Respiratory Questionnaire, Severe Respiratory Insufficiency Questionnaire).