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Efficacy and safety of mobile nasal high flow on exercise tolerance in patients with chronic obstructive pulmonary disease

Efficacy and safety of mobile nasal high flow on exercise tolerance in patients with chronic obstructive pulmonary disease

Fukahori Susumu

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

susumu-f@nagasaki-u.ac.jp

Fukahori Susumu

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

+81-95-819-7273

susumu-f@nagasaki-u.ac.jp

Recruiting

Feb. 20, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

crossover assignment

other

1: Individuals aged 40 years or older at the time of consent (irrespective of gender)
2: Respiratory function test results indicating a FEV1/FVC of less than 70% and 30%<=%FEV1 < 80%
*Test results obtained up to 3 months prior to the screening date are acceptable
3: Individuals who do not require oxygen administration in their daily activities
4: Individuals who have received a comprehensive explanation of this study and provided voluntary consent with full comprehension

1 Individuals who have been prescribed home oxygen therapy
2 Individuals experiencing significant impairment in daily functioning due to severe or comorbid conditions
3 Individuals unable to complete the 6-minute walking test due to ambulatory disorders or pain that impedes locomotion
4 Individuals with nasal obstruction
5 Other patients deemed unsuitable as study participants by the principal investigator

Both

Chronic obstructive pulmonary disease

A 6-minute walking test will be performed using a movable nasal high flow (AIRVO3TM)

6-minute walk test results (walking distance)

SpO2 during 6-minute walk test,
Difference in transcutaneous pCO2, respiratory rate, and modified Borg scale before and after 6-minute walk test
Recovery time
Distance walked before the first break
Time from the initiation of the 6-minute walk to the occurrence of the event, which is defined as the point at which SpO2 reaches 90%, transcutaneous pCO2 45 mmHg, and respiratory rate 22 breaths/min during the 6-minute walk.
Subjective symptoms reported by study participants and their opinions regarding device utilization

+81-95-819-7229

Feb. 10, 2025

Yes

The principal investigator will verify the purpose and scope of use, and if deemed appropriate, the data will be shared and made public following the necessary procedures.

none