Nasal high-flow versus nicht-invasive Beatmung bei Patienten mit stabil chronisch hyperkapnischer COPD

Background: Despite the encouraging results of non-invasive 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 NHF to compare effectiveness.

Methods: In a multi-centered, randomized, controlled, cross-over design, patients received six weeks of NHF ventilation followed by six weeks of NIV ventilation or vice-versa (TIBICO) between 2011 and 2016. COPD patients with stable daytime hypercapnia (pCO₂ ≥ 50 mmHg) were recruited from 13 German centers. The primary endpoint was pCO₂ changes from baseline Blood gas, lung function, quality of life, the 6 minute walking test, and duration of device use were secondary endpoints.

Results: 102 patients (mean+SD) age 65.3 ± 9.3 years, 61% females, BMI 23.1 ± 4.8 kg/m², 90% GOLD D, pCO2 56.5 ± 5.4 mmHg were randomized. PCO₂ levels decreased by 4.7% (n = 94; full analysis set; 95% CI 1.8 to 7.5, p = 0.002) using NHF and 7.1% (95% CI 4.1 to 10.1, p < 0.001) from baseline using NIV (indistinguishable to intention-to-treat analysis). The difference of pCO₂ changes between the two devices was − 1.4 mmHg (95% CI − 3.1 to 0.4, p = 0.12). Both devices had positive impact on blood gases and respiratory scores (SGRQ, SRI).

Conclusions: NHF may constitute an alternative to NIV in COPD patients with stable chronic hypercapnia, e.g. those not tolerating or rejecting NIV with respect to pCO₂ reduction and improvement in quality of life.

Registration: www.clinicaltrials.gov NCT02007772

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