Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
- Conditions
- Hypercapnic Respiratory FailureHypoxemic Respiratory Failure
- Registration Number
- NCT03872167
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
chronic respiratory failure
- Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%)
- Under 18 years old.
- Presence of severe uncontrolled cardiac comorbidity.
- Impossibility to achieve adaptation to therapy in the training session.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Partial pressure of oxygen (PaO2) two weeks Measure levels after each polysomnography using arterial blood gases
Partial pressure of carbon dioxide (PaCO2) two weeks Measure levels after each polysomnography using arterial blood gases
- Secondary Outcome Measures
Name Time Method Oxygen saving time below 90% (CT90%) one month Assess the polysomnography reduction in CT90% through the night study.
Trial Locations
- Locations (1)
Hospital Clinic Barcelona.
🇪🇸Barcelona, Spain
Hospital Clinic Barcelona.🇪🇸Barcelona, Spain