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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03872167

Enrollment

Registered

2019-03-13

Start date

2018-06-15

Completion date

2024-02-15

Last updated

2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnic Respiratory Failure, Hypoxemic Respiratory Failure

Keywords

NIV, hypoxemia, hypercapnia

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.

Interventions

DEVICEBIPAP, 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

DEVICEBIPAP, manual tritration.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Partial pressure of carbon dioxide (PaCO2)	two weeks	Measure levels after each polysomnography using arterial blood gases
Partial pressure of oxygen (PaO2)	two weeks	Measure levels after each polysomnography using arterial blood gases

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026