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

Hospital Clinic of Barcelona

Status: Completed

Conditions: Hypoxemic Respiratory Failure; Hypercapnic Respiratory Failure

Treatments: Device: BIPAP, manual tritration.; Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support

Study type: Interventional

Funder types: Other

Identifiers

NCT03872167

NIVHCLINIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

MANUAL

Active Comparator group

Description:

Manual titration of non-invasive mechanical ventilation using polysomnography and randomized

Treatment:

Device: BIPAP, manual tritration.

AUTOMATIC

Active Comparator group

Description:

Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.

Treatment:

Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support