Nasal high-flow versus noninvasive ventilation in patients with chronic hypercapnic COPD

Abstract

Background

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.

Methods

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 (pCO₂≥50 mmHg) were recruited from 13 German centers. The primary endpoint was pCO₂ changes from baseline blood gas, lung function, quality of life (QoL), the 6 min walking test, and duration of device use were secondary endpoints.

Results

A total of 102 patients (mean±SD) age 65.3±9.3 years, 61% females, body mass index 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 1.8–7.5, 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 pCO₂ 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).

Conclusions

NHF may constitute an alternative to NIV in COPD patients with stable chronic hypercapnia, eg, those not tolerating or rejecting NIV with respect to pCO₂ reduction and improvement in QoL.

Keywords:

• noninvasive ventilation
• nasal high-flow
• COPD
• hypercapnia

Acknowledgments

This study was an investigator-initiated project supported by TNI Medical AG through grants and provision of equipment. The sponsor had no role in the design and conduct of the study, the collection, management, analysis and interpretation of the data, the preparation, review or approval of the manuscript, or the decision to submit the manuscript.

Abbreviations list

(p)CO₂, (partial) pressure of carbon dioxide; (p)O_2, (partial) pressure of oxygen; 6MWT, 6-min walking test; EPAP, expiratory positive airway pressure; IPAP, inspiratory positive airway pressure; LTOT, long-term oxygen therapy; NHF, nasal high-flow; NIV, noninvasive ventilation; QoL, quality of life; RCT, randomized controlled trial; SNP, standard nasal prongs.

Data sharing statement

The authors will share the statistical analysis plan and study protocol upon request. An online supplement will be available. The data will be available for 5 years. Further data will be shared upon qualified request, in particular for meta-analyses or individual patient meta-analyses. In the latter case, those requesting data will be asked to provide a copy of an institutional review board approval and show that the meta-analysis has been registered in a public registry.

Author contributions

All authors contributed toward data analysis, drafting and revising the paper, gave final approval of the version to be published and agree to be accountable for all aspects of the work.

Disclosure

Dr. Bräunlich reports grants and non-financial support from TNI Medical AG during the conduct of the study; and grants, personal fees and non-financial support from TNI Medical AG and personal fees from Fisher&Paykel, outside the submitted work. Prof. Kähler reports non-financial support from TNI Medical AG. Prof. Randerath reports grants from Heinen und Löwenstein, Weinmann, Philips Respironics, and Inspire, outside the submitted work. Prof. Wirtz reports personal fees and non-financial support from TNI Medical AG, during the conduct of the study. All other authors have nothing to disclose.