An interventional study of High-flow nasal cannula and Low SpO2 in High-flow Nasal Cannula, Exercise Capacity and Chronic Respiratory Failure, sponsored by National Hospital Organization Minami Kyoto Hospital. Recruiting at 1 site in Japan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by National Hospital Organization Minami Kyoto Hospital · Not applicable, Interventional, and Other
The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear.
The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 297 are open to participants now.
This study's planned enrollment of 32 is below the median of 55 across 1,042 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →National Hospital Organization Minami Kyoto Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).
Other: High-flow nasal cannula
In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).
Other: Low SpO2
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
Low SpO2
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Plan to share: Undecided
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National Hospital Organization Minami Kyoto Hospital