CClinicalTrials.gg
CompletedNCT03872167Updated Feb 29, 2024

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

An interventional study of BIPAP, Intelligent automatic mode defined by assured volume with pressure support and BIPAP, manual tritration. in Hypoxemic Respiratory Failure and Hypercapnic Respiratory Failure, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypoxemic Respiratory Failure
  • Hypercapnic Respiratory Failure

Keywords

  • NIV
  • hypoxemia
  • hypercapnia
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 297 are open to participants now.

This study's enrollment of 26 is below the median of 55 across 1,042 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    MANUAL

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

    Device: BIPAP, manual tritration.

  • Active comparator
    AUTOMATIC

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

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

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.

06

What researchers measure

Primary outcomes

  1. Partial pressure of carbon dioxide (PaCO2)

    Measure levels after each polysomnography using arterial blood gases

    Time frame: two weeks

  2. Partial pressure of oxygen (PaO2)

    Measure levels after each polysomnography using arterial blood gases

    Time frame: two weeks

Secondary outcomes

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

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

    Time frame: one month

07

Study locations

1 site
  • Hospital Clinic Barcelona.
    Barcelona, 08036, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03872167
Lead sponsor
Hospital Clinic of Barcelona
Responsible party
CRISTINA EMBID LOPEZ (Principal Investigator, Hospital Clinic of Barcelona) — Principal investigator
First posted
Mar 13, 2019
Start date
Jun 15, 2018
Primary completion
Dec 31, 2023
Completion
Feb 15, 2024
Last update
Feb 29, 2024

Study contacts

CRISTINA EMBID LOPEZ, PHD
principal investigator · Hospital Clinic
MONICA C MATUTE VILLACIS, MD
principal investigator · Hospital Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion