EMG measurements of respiratory muscles for the titration of nocturnal non-invasive ventilation in stable chronic obstructive pulmonary disease patients; a randomised cross-over trial.

Rationale:
Long-term application of nocturnal non-invasive ventilation (NIV) in stable
hypercapnic chronic obstructive pulmonary disease (COPD) patients has long been
controversial as study results were not unequivocal. However, in the past 7
years, with a change in ventilatory strategy, clear benefits of chronic NIV
have been shown in COPD patients with chronic hypercapnic respiratory failure
(CHRF), though only in stable disease. As a consequence, this so called
high-intensity NIV, which is the concept of using higher positive inspiratory
airway pressures (IPAP) levels than used in most of the older trials in
addition to controlled ventilation with higher backup breathing frequencies
aiming for maximal arterial carbon dioxide (PaCO2) reduction, has gained
increasing attention.
However, it is unknown how high-intensity NIV works, and how to titrate the
optimal IPAP and optimal backup breathing frequency. Measuring respiratory
muscle activity might be a way to titrate NIV in COPD.

Objective: The aim of the present study is to investigate whether additional
titration on surface electromyography (EMG) of the diaphragm and intercostal
muscles improves outcomes of chronic NIV in patients with COPD and stable CHRF
in terms of better gas exchange after six weeks, lung function, patient comfort
and compliance and less patient-ventilator asynchrony (PVA).

Study design: A randomized, two-armed, crossover trial comparing regular
titration with additional respiratory EMG titration of NIV in stable
hypercapnic COPD.

Intervention: One group will be initiated on NIV according to standard care
protocol. For the other group, additional EMG measures whilst on NIV will be
made to titrate NIV.

There are no risks associated with participation to the study. The study aims
to improve the titration of a treatment, NIV, which was already indicated. The
EMG measurements used to improve this titration are non-invasive and not
associated with any discomfort for the patients. Furthermore, the additional
titration of NIV will not go beyond in clinical practice used settings. Most of
the measurements are part of daily routine in patients instituted on NIV.
Additional measurements done will be a lung function measurement after 6 weeks,
which is performed according to guidelines and daily practice, and the comfort
and health-related quality of life questionnaires (3 times).