Non Invasive Ventilation, Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAdjustment of back-up respiratory rate on bi-level ventilator
3 consecutive nights in randomized order, in either S (Spontaneous) mode, ST (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in ST (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort
Sponsors
Ligue Pulmonaire Genevoise
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Obesity-hypoventilation (OHS) patients, in stable clinical condition, treated with domiciliary nocturnal non invasive ventilation for at least two months
Exclusion criteria
* OHS patients: unstable cardio-respiratory status and/or acute cardio-respiratory failure three months before inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep structure | Night 1 | Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous capnography (PtcCO2) | Night 1 | Mean PtcCO2 during Night 1 |
| Correlation between microarousal index and autonomic arousal index | Night 1 | Correlation between microarousal index (assessed by EEG) and autonomic arousal index under NIV (assessed by pulse plethysmography) |
Countries
Switzerland
Outcome results
None listed