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COMPLETED
NCT07777497
NA

Respiratory Therapist-Supported Home Noninvasive Ventilation in Stable Severe COPD Without Hypercapnia

Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

View on ClinicalTrials.gov

Summary

Chronic obstructive pulmonary disease (COPD) can cause persistent breathing problems, reduced exercise capacity, and repeated worsening of symptoms. Noninvasive ventilation (NIV) provides breathing support through a mask. Although NIV is commonly used in patients with respiratory failure, its role in patients with stable severe COPD without hypercapnia is less clear. The purpose of this study was to evaluate the feasibility of a respiratory therapist-supported home NIV program and to explore its potential clinical effects in adults with stable severe COPD without hypercapnia. Participants used a bilevel positive airway pressure device at home for at least 6 hours per day for 3 months. Respiratory therapists provided education and helped set up and adjust the device in collaboration with physicians according to each participant's comfort and breathing pattern. Participants were assessed before starting home NIV and after 1 and 3 months of treatment. Assessments included walking capacity, lung function, arterial blood gas measurements, breathing symptoms, and COPD-related health status. The study also evaluated participants' ability to tolerate and continue home NIV. The findings were intended to determine whether a respiratory therapist-supported home NIV program is practical and potentially beneficial for patients with stable severe COPD without hypercapnia.

Official title: Feasibility of a Respiratory Therapist-Supported Home Noninvasive Ventilation Program in Stable Severe COPD Without Hypercapnia

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2024-01-18

Completion Date

2024-10-31

Last Updated

2026-08-20

Healthy Volunteers

No

Conditions

Interventions

DEVICE

BreathePal Bilevel Positive Pressure System (GFM50-MD2201)

Participants used the BreathePal Bilevel Positive Pressure System (GFM50-MD2201) at home for at least 6 hours per day for 3 months. Initial inspiratory positive airway pressure (IPAP) was set at 10 cm H2O and expiratory positive airway pressure (EPAP) at 5 cm H2O. Settings could be adjusted by respiratory therapists according to physician instructions, participant comfort, ventilator synchrony, and clinical response.

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, Taiwan