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Completed

NCT Number: NCT03872167

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

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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Key information

Conditions

Hypoxemic Respiratory Failure Hypercapnia Hypercapnic Respiratory Failure Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona.

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

BIPAP, manual tritration.

Device

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

Primary outcomes

  1. Partial pressure of carbon dioxide (PaCO2)

    Time frame: two weeks

    Measure levels after each polysomnography using arterial blood gases

  2. Partial pressure of oxygen (PaO2)

    Time frame: two weeks

    Measure levels after each polysomnography using arterial blood gases

Secondary outcomes

  1. Oxygen saving time below 90% (CT90%)

    Time frame: one month

    Assess the polysomnography reduction in CT90% through the night study.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Mar 13, 2019
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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