Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial

Kazuma Nagata, Takeo Horie, Naohiko Chohnabayashi, Torahiko Jinta, Ryosuke Tsugitomi, Akira Shiraki, Fumiaki Tokioka, Toru Kadowaki, Akira Watanabe, Motonari Fukui, Takamasa Kitajima, Susumu Sato, Toru Tsuda, Nobuhito Kishimoto, Hideo Kita, Yoshihiro Mori, Masayuki Nakayama, Kenichi Takahashi, Tomomasa Tsuboi, Makoto Yoshida, Osamu Hataji, Satoshi Fuke, Michiko Kagajo, Hiroki Nishine, Hiroyasu Kobayashi, Hiroyuki Nakamura, Miyuki Okuda, Sayaka Tachibana, Shohei Takata, Hisayuki Osoreda, Kenichi Minami, Takashi Nishimura, Tadashi Ishida, Jiro Terada, Naoko Takeuchi, Yasuo Kohashi, Hiromasa Inoue, Yoko Nakagawa, Takashi Kikuchi, Keisuke Tomii, Kazuma Nagata, Takeo Horie, Naohiko Chohnabayashi, Torahiko Jinta, Ryosuke Tsugitomi, Akira Shiraki, Fumiaki Tokioka, Toru Kadowaki, Akira Watanabe, Motonari Fukui, Takamasa Kitajima, Susumu Sato, Toru Tsuda, Nobuhito Kishimoto, Hideo Kita, Yoshihiro Mori, Masayuki Nakayama, Kenichi Takahashi, Tomomasa Tsuboi, Makoto Yoshida, Osamu Hataji, Satoshi Fuke, Michiko Kagajo, Hiroki Nishine, Hiroyasu Kobayashi, Hiroyuki Nakamura, Miyuki Okuda, Sayaka Tachibana, Shohei Takata, Hisayuki Osoreda, Kenichi Minami, Takashi Nishimura, Tadashi Ishida, Jiro Terada, Naoko Takeuchi, Yasuo Kohashi, Hiromasa Inoue, Yoko Nakagawa, Takashi Kikuchi, Keisuke Tomii

Abstract

Rationale: The long-term effects of using a high-flow nasal cannula for chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease remain unclear. Objectives: To assess whether long-term high-flow nasal cannula use reduces the number of exacerbations and improves other physiological parameters in patients with chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease. Methods: We enrolled 104 participants (aged ⩾40 yr) with daytime hypercapnia (Global Initiative for Chronic Obstructive Lung Disease stages 2-4) receiving long-term oxygen therapy (⩾16 h/d for ⩾1 mo) and randomly assigned them to high-flow nasal cannula/long-term oxygen therapy and long-term oxygen therapy groups. The primary endpoint was the moderate or severe exacerbation rate. We compared changes from baseline in arterial blood gas values, peripheral oxygen saturation, pulmonary function, health-related quality-of-life scores, and the 6-minute-walk test. Measurements and Main Results: High-flow nasal cannula use significantly reduced the rate of moderate/severe exacerbations (unadjusted mean count 1.0 vs. 2.5, a ratio of the adjusted mean count between groups [95% confidence interval] of 2.85 [1.48-5.47]) and prolonged the duration without moderate or severe exacerbations. The median time to first moderate or severe exacerbation in the long-term oxygen therapy group was 25 (14.1-47.4) weeks; this was not reached in the high-flow nasal cannula/long-term oxygen therapy group. High-flow nasal cannula use significantly improved health-related quality of life scores, peripheral oxygen saturation, and specific pulmonary function parameters. No safety concerns were identified. Conclusions: A high-flow nasal cannula is a reasonable therapeutic option for patients with stable hypercapnic chronic obstructive pulmonary disease and a history of exacerbations. Clinical trial registered with www.umin/ac.jp (UMIN000028581) and www.clinicaltrials.gov (NCT03282019).

Keywords: chronic obstructive pulmonary disease; hypercapnia; oxygen inhalation therapy; pulmonary disease; respiratory insufficiency.

Figures

Figure 1.
Figure 1.
Flow diagram of participant inclusion and exclusion. AE = adverse event; COPD = chronic obstructive pulmonary disease; HFNC = high-flow nasal cannula oxygen therapy; LTOT = long-term oxygen therapy; NPPV = noninvasive positive pressure ventilation.
Figure 2.
Figure 2.
Time to the first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation and overall survival (OS). The upper (A) and lower (B) graphs show the Kaplan-Meier curves for the time to the first moderate or severe COPD exacerbation and OS, respectively. The solid and broken lines indicate the high-flow nasal cannula oxygen therapy/long-term oxygen therapy (HFNC/LTOT) and LTOT-alone groups, respectively. W = weeks.
Figure 3.
Figure 3.
Least squared means (LSMs) with SEs for health-related quality of life (HRQOL) scores. (A) St. George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease (SGRQ-C) total score. (B) SGRQ-C symptom score. (C) SGRQ-C activity score. (D) SGRQ-C impact score. (E) Severe Respiratory Insufficiency (SRI) Questionnaire score. (F) Pittsburgh Sleep Quality Index–Japanese version (PSQI-J) score. Solid and broken lines indicate the high-flow nasal cannula oxygen therapy/long-term oxygen therapy (HFNC/LTOT) and LTOT-alone groups, respectively. W = weeks.

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