Effects of nighttime non-invasive ventilation on COPD patients
Nocturnal Non-Invasive Ventilation in COPD Patients With Stable Hypercapnic Respiratory Failure: Why and in Which Patient Might This be Effective?
NA · University Medical Center Groningen · NCT03053973
This study is testing whether using a special breathing machine at night can help people with COPD breathe better and feel more comfortable compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 1 site (Groningen) |
| Trial ID | NCT03053973 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of nocturnal non-invasive ventilation (NIV) on patients with stable chronic obstructive pulmonary disease (COPD) who experience chronic hypercapnic respiratory failure. It aims to assess changes in forced expiratory volume (FEV1) after three months of NIV compared to standard care, while also exploring the relationship between FEV1 changes and airway inflammation, remodeling, and lung hyperinflation. The study will also identify predictors of a favorable response to chronic NIV in these patients through a multicenter randomized controlled design.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stable COPD (GOLD stage III or IV) and chronic hypercapnic respiratory failure.
Not a fit: Patients with obstructive sleep apnea, significant cardiac comorbidities, or those on certain medications like oral corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved lung function and quality of life for COPD patients using nocturnal NIV.
How similar studies have performed: Previous studies have shown positive outcomes with non-invasive ventilation in COPD patients, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced expiratory volume (FVC)\< 70% and FEV1\< 50% predicted; PaCO2 \> 6.0 kilopascal (kPa) in stable condition, which means no COPD exacerbation for 4 weeks and a pH \> 7.35) * Age \> 18 years * Written informed consent is obtained Exclusion Criteria: For the randomised Inflammation part a potential subject who meets any of the following criteria will be excluded from participation in this study: * Oral corticosteroids or roflumilast * A history of lung volume reduction surgery * Body mass index (BMI) \> 35 kg/m2 * Obstructive sleep apnoea (OSA) (apnoea/hypopnea index (AHI) \>15/hr): to exclude OSA a polygraphy will be done at baseline * PaCO2 ≥ 8.0 kPa or PaO2 \< 6.5 kPa at rest without oxygen * Instable cardiac comorbidities (left ventricular ejection fraction (LVEF) \<40%, instable coronary artery disease, instable heart failure)
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Peter J Wijkstra, MD PhD — University Medical Center Groningen
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Noninvasive Ventilation, COPD, airway inflammation, airway remodeling, health-related auality of life, forced expiratory volume 1 second