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Completed
NCT07777497
Respiratory Therapist-Supported Home Noninvasive Ventilation in Stable Severe COPD Without Hypercapnia
Conditions: COPD
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 14
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Location: Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Sanmin Dist
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 20 years or older.
* Diagnosis of severe chronic obstructive pulmonary disease (COPD).
* Post-bronchodilator FEV1/FVC \< 0.70.
* FEV1 \< 50% of the predicted value with at least one moderate or severe COPD exacerbation in the previous year; or FEV1 50%-80% of the predicted value with at least two moderate exacerbations or at least one severe exacerbation in the previous year.
* Able to breathe spontaneously and not dependent on continuous bilevel positive airway pressure ventilation for life support.
* No acute myocardial infarction or life-threatening cardiac arrhythmia.
* No acute facial injury.
* No indication for an artificial airway for conditions such as secretion clearance or upper airway obstruction.
Exclusion Criteria:
* Pregnancy or suspected pregnancy.
* Hemodynamic instability.
* Recent facial surgery.
* Excessive or excessively thick respiratory secretions.
* Sleep apnea.
* Other causes of chronic airway obstruction, such as bronchiectasis.
* Significant comorbid disease, such as left ventricular failure.
* Contraindications to noninvasive positive-pressure ventilation, including acute sinusitis, otitis media, pneumothorax, pathological hypotension, dehydration, cerebrospinal fluid leak, or recent cranial surgery or trauma.
Source: ClinicalTrials.gov (NCT07777497). StuddyBuddy aggregates publicly available trial information.