Obesity Clinical Trial
Official title:
Patient-ventilator Interactions in Long Term Non-invasive Ventilation (NIV): Influence of Back-up Frequency
In patients under bi-level pressure support ventilation for obesity hypoventilation
syndrome, this study aims to determine if it is better, in terms of efficacy and
patient-ventilator synchronisation to use
- Spontaneous mode (S)
- Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the
respiratory rate of the patient
- Timed mode (T), with a ventilator respiratory rate above that of the patient. This
issue has to our knowledge only been marginally studied without any consensus.
Eligibility: patients under home bi-level pressure support ventilation for obesity
hypoventilation in a stable clinical condition, aged over 18
Methods:
Three consecutive sleep studies in a randomised sequence with usual parameters Inspiratory
Positive Airway Pressure(IPAP), Expiratory Positive Airway Pressure (EPAP) and change of
only back up respiratory rate (RR): one night in a spontaneous mode, one with an
intermediate RR, and one with a RR above that of the patient
Endpoints:
Quality of sleep and sleep structure (polysomnography), patient-ventilator synchronisation
and respiratory events under NIV, efficacy of ventilation: oxygen saturation measured by
pulse oxymetry (SaO2); transcutaneous capnography (PtcCO2), and comfort.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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