Journal of thoracic disease · 2026
Safety and effectiveness of a portable nasal high-flow device for improving exercise tolerance in patients with chronic obstructive pulmonary disease: a study protocol for an open-label, randomized, crossover pilot trial.
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Fukushima Chizu, Fukahori Susumu, Iriki Jun, Tsukamoto Yusei, Obase Yasushi, Kozu Ryo, Yanagita Yorihide, Ayuse Takao, Hosogaya Naoki, Hanada Masatoshi, Oikawa Masato, Kawazoe Yurika, Takemoto Shinnosuke, Takazono Takahiro, Sakamoto Noriho, Nishino Tomoya, Mukae Hiroshi
Аннотация
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease characterized by airflow limitation and exertional dyspnea, leading to reduced exercise tolerance and physical inactivity. Nasal high-flow (NHF) therapy delivers heated and humidified gas at a high flow rate through a nasal cannula, washing out anatomical dead space, providing a small degree of positive airway pressure, improving ventilation efficiency, and reducing the work of breathing. In addition, adequate humidification may enhance ciliary clearance. The AIRVO3TM (Fisher & Paykel Healthcare, Auckland, New Zealand) is a novel portable NHF device that incorporates these features and can be used during ambulation. Using AIRVO3TM during exertion may improve exercise tolerance in patients with COPD; however, its safety and effectiveness in ambulatory patients have not yet been established.
METHODS: This is a single-center, early-phase, open-label, randomized, two-period crossover pilot trial conducted at Nagasaki University Hospital, designed to evaluate the acute, within-day effects of AIRVO3TM on exercise tolerance during a single visit. Twenty patients with moderate to severe COPD will perform two 6-minute walk tests (6MWT) in a randomized order: one with AIRVO3TM and one without the device. The primary outcome is the 6-minute walk distance (6MWD). Secondary outcomes include percutaneous oxygen saturation (SpO2), transcutaneous partial pressure of carbon dioxide (PtcCO2), respiratory rate, pulse rate, Borg dyspnea scale score, time to desaturation (SpO2 ≤90%), time to PtcCO2 ≥45 mmHg, time to respiratory rate ≥22/min, walking distance to the first rest, patient-reported comfort, and subjective symptoms. Safety outcomes include the incidence of SpO2 <90%, adverse events (AEs), device-related discomfort, and withdrawal or dropout. Data will be analyzed primarily using paired t-tests and mixed-effects models that are appropriate for a crossover design.
DISCUSSION: This trial will evaluate whether a portable NHF device increases exercise tolerance and is safe during ambulation in patients with COPD who do not require long-term oxygen therapy. By using room air [finspiratory oxygen fraction (FiO2) 21%] and focusing on high flow rather than high oxygen concentration, this study will clarify the pure effects of high-flow nasal therapy on exertional capacity. If the AIRVO3TM device is shown to be effective and acceptable, it may expand the options for pulmonary rehabilitation and daily physical activity in patients with COPD. Because all assessments are performed during a single study visit, this trial specifically evaluates short-term, acute responses to AIRVO3TM rather than long-term training effects of repeated use.
TRIAL REGISTRATION: The study is registered in the Japan Registry of Clinical Trials (jRCT; trial ID jRCTs072240116; registered on February 20, 2025; https://jrct.mhlw.go.jp/latest-detail/jRCTs072240116). This article describes the protocol version 1.1 (March 11, 2025).
METHODS: This is a single-center, early-phase, open-label, randomized, two-period crossover pilot trial conducted at Nagasaki University Hospital, designed to evaluate the acute, within-day effects of AIRVO3TM on exercise tolerance during a single visit. Twenty patients with moderate to severe COPD will perform two 6-minute walk tests (6MWT) in a randomized order: one with AIRVO3TM and one without the device. The primary outcome is the 6-minute walk distance (6MWD). Secondary outcomes include percutaneous oxygen saturation (SpO2), transcutaneous partial pressure of carbon dioxide (PtcCO2), respiratory rate, pulse rate, Borg dyspnea scale score, time to desaturation (SpO2 ≤90%), time to PtcCO2 ≥45 mmHg, time to respiratory rate ≥22/min, walking distance to the first rest, patient-reported comfort, and subjective symptoms. Safety outcomes include the incidence of SpO2 <90%, adverse events (AEs), device-related discomfort, and withdrawal or dropout. Data will be analyzed primarily using paired t-tests and mixed-effects models that are appropriate for a crossover design.
DISCUSSION: This trial will evaluate whether a portable NHF device increases exercise tolerance and is safe during ambulation in patients with COPD who do not require long-term oxygen therapy. By using room air [finspiratory oxygen fraction (FiO2) 21%] and focusing on high flow rather than high oxygen concentration, this study will clarify the pure effects of high-flow nasal therapy on exertional capacity. If the AIRVO3TM device is shown to be effective and acceptable, it may expand the options for pulmonary rehabilitation and daily physical activity in patients with COPD. Because all assessments are performed during a single study visit, this trial specifically evaluates short-term, acute responses to AIRVO3TM rather than long-term training effects of repeated use.
TRIAL REGISTRATION: The study is registered in the Japan Registry of Clinical Trials (jRCT; trial ID jRCTs072240116; registered on February 20, 2025; https://jrct.mhlw.go.jp/latest-detail/jRCTs072240116). This article describes the protocol version 1.1 (March 11, 2025).