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

JRCT ID: jRCTs072240116

Registered date:20/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic obstructive pulmonary disease
• Date of first enrollment: 20/02/2025
• Target sample size: 20
• Study type: Interventional
• Intervention(s): A 6-minute walking test will be performed using a movable nasal high flow (AIRVO3TM)

Outcome(s)

• Primary Outcome: 6-minute walk test results (walking distance)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Fukahori Susumu
• Source(s) of Monetary Support: Fisher &amp; Paykel Healthcare Limited