Respiratory InsufficiencyMASHUPNCT06483984
Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
A study testing Noninvasive ventilation in people with Respiratory Insufficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Nov 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Acute respiratory failure with
- PaCO2 ≥ 45 mmHg;
- Arterial pH < 7.35;
- Signed written informed consent
Who cannot join
- Respiratory rate < 12 bpm;
- Immediate need for intubation;
- Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
- Metabolic Acidosis;
- Recent head surgery or anatomy that prevent the application of facemasks;
- Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
- Any contraindications to facemask noninvasive ventilation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
Roma
Domenico Luca Grieco, MD, +39063015 ext. 4490, domenicoluca.grieco@unicatt.it
- Recruiting
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome
Domenico Luca Grieco, MD
Massimo Antonelli, MD
About this study
Official title: Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
- Conditions
- Respiratory Insufficiency
- Being tested
- Noninvasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilationDevice
Also called Positive-pressure ventilation
Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.
| Study group | Role | What they receive |
|---|---|---|
| Facemask 'Nivairo' | Active comparator | Oronasal mask for noninvasive ventilation Receives: Device: Noninvasive ventilation |
| Bridge-free facemask 'Visairo' | Experimental | Bridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils Receives: Device: Noninvasive ventilation |
| Facemask 'Optiniv' | Experimental | Facemask for noninvasive ventilation favoring carbon dioxide washout Receives: Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic work of breathing
Simplified pressure-time-product per minute of the transdiaphragmatic pressure
Measured: 45 minutes
Secondary outcomes (11)
Normalized metabolic work of breathing
Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg
Measured: 45 minutes
Inspiratory effort, expressed in cmH2O
Positive inspiratory deflection of transdiaphragmatic pressure
Measured: 45 minutes
Corrected minute ventilation
Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg
Measured: 45 minutes
Dyspnea
Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea).
Measured: 45 minutes
Discomfort
Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort).
Measured: 45 minutes
End-expiratory lung volume
Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography
Measured: 45 minutes
Regional End-expiratory lung volume
Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography
Measured: 45 minutes
Arterial carbon dioxide, expressed in mmHg
Arterial carbon dioxide, measured with arterial blood gas analysis
Measured: 45 minutes
Arterial acid-base state
Arterial pH, measured with arterial blood gas analysis
Measured: 45 minutes
Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure
Expiratory increases in gastrinc pressure
Measured: 45 minutes
Tidal volume distribution
Tidal volume distribution in the different lung regions (ventral-midventral-middorsal-dorsal),assessed with electrical impedance tomography
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Nov 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Antonelli, MD, Study chair, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483984
- Sponsor's protocol ID
- 6462
- Acronym
- MASHUP
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06483984
- Acronym / sponsor ID
- MASHUP / 6462
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facemask 'Nivairo' | Active comparator | Device: Noninvasive ventilationOronasal mask for noninvasive ventilation |
| Bridge-free facemask 'Visairo' | Experimental | Device: Noninvasive ventilationBridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils |
| Facemask 'Optiniv' | Experimental | Device: Noninvasive ventilationFacemask for noninvasive ventilation favoring carbon dioxide washout |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute respiratory failure with
- PaCO2 ≥ 45 mmHg;
- Arterial pH < 7.35;
- Signed written informed consent
Key exclusion criteria (7 listed)
- Respiratory rate < 12 bpm;
- Immediate need for intubation;
- Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
- Metabolic Acidosis;
- Recent head surgery or anatomy that prevent the application of facemasks;
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 |
|---|---|---|
| Noninvasive ventilationAlso: Positive-pressure ventilationRespiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode. | Device | Bridge-free facemask 'Visairo', Facemask 'Nivairo', Facemask 'Optiniv' |
Primary outcome
Metabolic work of breathing
Time frame: 45 minutes
Simplified pressure-time-product per minute of the transdiaphragmatic pressure
11 secondary outcomes
Normalized metabolic work of breathing
Time frame: 45 minutes
Inspiratory effort, expressed in cmH2O
Time frame: 45 minutes
Corrected minute ventilation
Time frame: 45 minutes
Dyspnea
Time frame: 45 minutes
Discomfort
Time frame: 45 minutes
End-expiratory lung volume
Time frame: 45 minutes
Regional End-expiratory lung volume
Time frame: 45 minutes
Arterial carbon dioxide, expressed in mmHg
Time frame: 45 minutes
Arterial acid-base state
Time frame: 45 minutes
Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure
Time frame: 45 minutes
Tidal volume distribution
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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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.
Massimo Antonelli, MD study chair
Catholic University of the Sacred Heart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation in people with Respiratory Insufficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico Luca Grieco, MD (+39063015 ext. 4490, domenicoluca.grieco@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic work of breathing (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.