Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.

Conditions
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Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support
* Device: BIPAP, manual tritration.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic respiratory failure Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%) Exclusion Criteria: Under 18 years old. Presence of severe uncontrolled cardiac comorbidity. Impossibility to achieve adaptation to therapy in the training session.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MANUAL<br>Manual titration of non-invasive mechanical ventilation using polysomnography and randomized | Device: BIPAP, manual tritration.<br>* Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.<br>|
| Active Comparator: AUTOMATIC<br>Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support. | Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support<br>* Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saving time below 90% (CT90%) | Assess the polysomnography reduction in CT90% through the night study. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIV, hypoxemia, hypercapnia