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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustment of back-up respiratory rate on bi-level ventilator | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep structure | Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals) | Night 1 |
| Sleep structure | Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals) | Night 2 |
| Sleep structure | Quantification of quality of sleep assessed by polysomnography (sleep stages, arousals) | Night 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Transcutaneous capnography (PtcCO2) | Mean PtcCO2 during Night 1 | Night 1 |
| Transcutaneous capnography (PtcCO2) | Mean PtcCO2 during night 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Janssens, MD | University Hospital, Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University hospital - Sleep laboratory | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25737571 | Derived | Georges M, Adler D, Contal O, Espa F, Perrig S, Pepin JL, Janssens JP. Reliability of Apnea-Hypopnea Index Measured by a Home Bi-Level Pressure Support Ventilator Versus a Polysomnographic Assessment. Respir Care. 2015 Jul;60(7):1051-6. doi: 10.4187/respcare.03633. Epub 2015 Mar 3. | |
| 22556317 | Derived | Contal O, Adler D, Borel JC, Espa F, Perrig S, Rodenstein D, Pepin JL, Janssens JP. Impact of different backup respiratory rates on the efficacy of noninvasive positive pressure ventilation in obesity hypoventilation syndrome: a randomized trial. Chest. 2013 Jan;143(1):37-46. doi: 10.1378/chest.11-2848. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Night 2 |
| Transcutaneous capnography (PtcCO2) | Mean PtcCO2 during night 3 | Night 3 |
| Correlation between microarousal index and autonomic arousal index | Correlation between microarousal index (assessed by EEG) and autonomic arousal index under NIV (assessed by pulse plethysmography) | Night 1 |
| Correlation between microarousal index and autonomic arousal index | Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography) | Night 2 |
| Correlation between microarousal index and autonomic arousal index | Correlation between microarousal index (measured by EEG) and autonomic arousal index (measured by pulse plethysmography) | Night 3 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |