Hypoxemic Respiratory FailureNCT03872167
Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
A study testing BIPAP, Intelligent automatic mode defined by assured volume with pressure support and BIPAP, manual tritration. in people with Hypoxemic Respiratory Failure and Hypercapnic Respiratory Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure
- What is being tested?
- BIPAP, Intelligent automatic mode defined by assured volume with pressure support and BIPAP, manual tritration.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2018to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%)
Who cannot join
- Under 18 years old.
- Presence of severe uncontrolled cardiac comorbidity.
- Impossibility to achieve adaptation to therapy in the training session.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.
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.
- Being tested
- BIPAP, Intelligent automatic mode defined by assured volume with pressure support, BIPAP, manual tritration.
- Keywords
- NIV, hypoxemia, hypercapnia
- Medical subject headings
- Respiratory Insufficiency, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAP, Intelligent automatic mode defined by assured volume with pressure supportDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MANUAL | Active comparator | Manual titration of non-invasive mechanical ventilation using polysomnography and randomized Receives: Device: BIPAP, manual tritration. |
| AUTOMATIC | Active comparator | Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support. Receives: Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of carbon dioxide (PaCO2)
Measure levels after each polysomnography using arterial blood gases
Measured: two weeks
Partial pressure of oxygen (PaO2)
Measure levels after each polysomnography using arterial blood gases
Measured: two weeks
Secondary outcomes (1)
Oxygen saving time below 90% (CT90%)
Assess the polysomnography reduction in CT90% through the night study.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 Jun 2018
- Primary completion31 Dec 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CRISTINA EMBID LOPEZ, Hospital Clinic of Barcelona
- Investigators
- CRISTINA EMBID LOPEZ, PHD, Principal investigator, Hospital ClinicMONICA C MATUTE VILLACIS, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872167
- Sponsor's protocol ID
- NIVHCLINIC
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matute-Villacis M, Puig Dupre M, Gascuena D, Moraleda A, Guerrero Romero G, Lopez-Escuredo L, Dalmases M, Agusti A, Embid C. Automatic alveolar ventilation-targeted NIV mode vs polysomnographic titration of fixed pressure in naive patients with chronic respiratory failure. Sleep. 2026 Jul 13;49(7):zsag085. doi: 10.1093/sleep/zsag085.
PubMed 41885563
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.
- ClinicalTrials.gov ID
- NCT03872167
- Acronym / sponsor ID
- NIVHCLINIC
- Keywords
- NIV, hypoxemia, hypercapnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MANUAL | Active comparator | Device: BIPAP, manual tritration.Manual titration of non-invasive mechanical ventilation using polysomnography and randomized |
| AUTOMATIC | Active comparator | Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure supportAutomatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%)
Key exclusion criteria (3 listed)
- Under 18 years old.
- Presence of severe uncontrolled cardiac comorbidity.
- Impossibility to achieve adaptation to therapy in the training session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIPAP, Intelligent automatic mode defined by assured volume with pressure supportCorrection of night ventilation through an automatic mode of ventilation with assured volume with pressure support | Device | AUTOMATIC |
| BIPAP, manual tritration.Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography. | Device | MANUAL |
Primary outcome
Partial pressure of carbon dioxide (PaCO2)
Time frame: two weeks
Measure levels after each polysomnography using arterial blood gases
Partial pressure of oxygen (PaO2)
Time frame: two weeks
Measure levels after each polysomnography using arterial blood gases
1 secondary outcome
Oxygen saving time below 90% (CT90%)
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 41885563Matute-Villacis M, Puig Dupre M, Gascuena D, Moraleda A, Guerrero Romero G, Lopez-Escuredo L, Dalmases M, Agusti A, Embid C. Automatic alveolar ventilation-targeted NIV mode vs polysomnographic titration of fixed pressure in naive patients with chronic respiratory failure. Sleep. 2026 Jul 13;49(7):zsag085. doi: 10.1093/sleep/zsag085.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CRISTINA EMBID LOPEZ, PHD principal investigator
Hospital Clinic
MONICA C MATUTE VILLACIS, MD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIPAP, Intelligent automatic mode defined by assured volume with pressure support and BIPAP, manual tritration. in people with Hypoxemic Respiratory Failure and Hypercapnic Respiratory Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial pressure of carbon dioxide (PaCO2) (time frame: two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.