Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Partial pressure of oxygen (PaO2)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
MANUAL
Manual titration of non-invasive mechanical ventilation using polysomnography and randomized
Intervention: BIPAP, manual tritration. (Device)
AUTOMATIC
Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.
Intervention: BIPAP, Intelligent automatic mode defined by assured volume with pressure support (Device)
Outcomes
Primary Outcomes
Partial pressure of oxygen (PaO2)
Time Frame: two weeks
Measure levels after each polysomnography using arterial blood gases
Partial pressure of carbon dioxide (PaCO2)
Time Frame: two weeks
Measure levels after each polysomnography using arterial blood gases
Secondary Outcomes
- Oxygen saving time below 90% (CT90%)(one month)
Investigators
CRISTINA EMBID LOPEZ
Principal Investigator
Hospital Clinic of Barcelona