The Effects of Nocturnal Non-invasive Ventilation in Stable COPD

Launched by PETER WIJKSTRA · Feb 12, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called nocturnal non-invasive ventilation (NIV) on patients with chronic obstructive pulmonary disease (COPD) who have high levels of carbon dioxide in their blood. The researchers want to find out if using NIV at night can help improve lung function, specifically how much air a patient can forcefully exhale in one second (known as FEV1). They will compare the results of patients using NIV to those receiving standard care without it. The study will also look at how changes in lung function relate to inflammation in the airways and overall lung health, and identify which patients are most likely to benefit from this treatment.

To be eligible for the trial, participants must be adults over 18 years old with severe COPD, specifically those who are stable and have not experienced an exacerbation (worsening of symptoms) in the past month. They should meet certain criteria regarding lung function and carbon dioxide levels. Participants can expect to be monitored for six months, with assessments of their lung function and quality of life at three and six months after starting NIV. This research is important because it could lead to better understanding and treatment options for patients with COPD.

Gender

ALL

Eligibility 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)