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To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.
Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MANUAL | Active Comparator | Manual titration of non-invasive mechanical ventilation using polysomnography and randomized |
|
| AUTOMATIC | Active Comparator | Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIPAP, Intelligent automatic mode defined by assured volume with pressure support | Device | Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support |
| Measure | Description | Time Frame |
|---|---|---|
| Partial pressure of carbon dioxide (PaCO2) | Measure levels after each polysomnography using arterial blood gases | two weeks |
| Partial pressure of oxygen (PaO2) | Measure levels after each polysomnography using arterial blood gases | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saving time below 90% (CT90%) | Assess the polysomnography reduction in CT90% through the night study. | one month |
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Inclusion Criteria: chronic respiratory failure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CRISTINA EMBID LOPEZ, PHD | Hospital Clinic | Principal Investigator |
| MONICA C MATUTE VILLACIS, MD | Hospital Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Barcelona. | Barcelona | 08036 | Spain |
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| BIPAP, manual tritration. | Device | Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography. |
|
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000860 | Hypoxia |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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