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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2024-02-15

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.

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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.

Conditions

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Hypoxemic Respiratory Failure Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MANUAL

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

Group Type ACTIVE_COMPARATOR

BIPAP, manual tritration.

Intervention Type DEVICE

Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.

AUTOMATIC

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support

Interventions

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

Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support

Intervention Type DEVICE

BIPAP, manual tritration.

Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No