Acute Hypoxemic Respiratory FailureNCT06210386
Physiology of Helmet vs. Facemask Noninvasive Ventilation
A study testing Noninvasive ventilation in people with Acute Hypoxemic Respiratory Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- 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
- 1 siteItaly
- Study dates
- 19 Jan 2024to 15 Sep 2025
- 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
- Acute hypoxemic respiratory failure and PaO2/FiO2<200 mmHg
- PaCO2<45 mmHg
- Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload
Who cannot join
- Pregnancy
- Contraindication to helmet or facemask noninvasive ventilation
- Contraindication to esophageal manometry
- Contraindication to electrical-impedance tomography monitoring
- Recent surgery involving the abdomen or the thorax
- Pneumothorax or documented barotrauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Effects of Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure
The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.
In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).
- Conditions
- Acute Hypoxemic Respiratory Failure
- 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
noninvasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Helmet noninvasive ventilation | Experimental | 1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). Receives: Device: Noninvasive ventilation |
| Facemask noninvasive ventilation (facemask settings) | Active comparator | 1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O). Receives: Device: Noninvasive ventilation |
| Facemask noninvasive ventilation (helmet settings) | Active comparator | 1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). Receives: Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort
negative deflection in esophageal pressure
Measured: 1 hour
End-expiratory lung impedance
Electrical-impedance derived end-expiratory lung volume
Measured: 1 hour
Secondary outcomes (12)
Tidal volume
Electrical-impedance derived tidal volume size
Measured: 1 hour
Work of breathing
Esophageal pressure simplified pressure-time product
Measured: 1 hour
Respiratory rate
Respiratory rate per minute
Measured: 1 hour
Dynamic transpulmonary driving pressure
Tidal change in transpulmonary pressure
Measured: 1 hour
Compliance
Ratio of tidal volume to transpulmonary driving pressure
Measured: 1 hour
Dyspnea
Dyspnea rated through a visual analog scale (ranging from 0 to 10, with representing most severe dyspnea) adapted for critically ill patients
Measured: 1 hour
Discomfort
Device-related discomfort (ranging from 0 to 10, with representing most severe dyspnea) rated through a visual analog scale adapted for critically ill patients
Measured: 1 hour
Oxygenation
PaO2/FiO2 ratio
Measured: 1 hour
Pendelluft extent
Pendelluft extent, expressed in % of the total tidal volume
Measured: 1 hour
Corrected minute ventilation
The product of tidal volume and respiratory rate, normalized to PaCO2. This value is expressed in Arbitrary units per minute divided by mmHg and is a proxy of dead space
Measured: 1 hour
Arteria Carbon dioxide tension
PaCO2
Measured: 1 hour
Tidal volume distribution
Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start19 Jan 2024
- Primary completion31 Jul 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies 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
- Model description
- Crossover randomized trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico L. Grieco, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210386
- Sponsor's protocol ID
- 5173-1
- Status last verified
- Sep 2025
- First submitted
- 2 Jan 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon reasonable request
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 Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06210386
- Acronym / sponsor ID
- 5173-1
- Conditions
- Acute Hypoxemic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 18 Jan 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 optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.
In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Helmet noninvasive ventilation | Experimental | Device: Noninvasive ventilation1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). |
| Facemask noninvasive ventilation (facemask settings) | Active comparator | Device: Noninvasive ventilation1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O). |
| Facemask noninvasive ventilation (helmet settings) | Active comparator | Device: Noninvasive ventilation1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute hypoxemic respiratory failure and PaO2/FiO2<200 mmHg
- PaCO2<45 mmHg
- Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload
Key exclusion criteria (6 listed)
- Pregnancy
- Contraindication to helmet or facemask noninvasive ventilation
- Contraindication to esophageal manometry
- Contraindication to electrical-impedance tomography monitoring
- Recent surgery involving the abdomen or the thorax
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 ventilationnoninvasive ventilation | Device | Facemask noninvasive ventilation (facemask settings), Facemask noninvasive ventilation (helmet settings), Helmet noninvasive ventilation |
Primary outcome
Inspiratory effort
Time frame: 1 hour
negative deflection in esophageal pressure
End-expiratory lung impedance
Time frame: 1 hour
Electrical-impedance derived end-expiratory lung volume
12 secondary outcomes
Tidal volume
Time frame: 1 hour
Work of breathing
Time frame: 1 hour
Respiratory rate
Time frame: 1 hour
Dynamic transpulmonary driving pressure
Time frame: 1 hour
Compliance
Time frame: 1 hour
Dyspnea
Time frame: 1 hour
Discomfort
Time frame: 1 hour
Oxygenation
Time frame: 1 hour
Pendelluft extent
Time frame: 1 hour
Corrected minute ventilation
Time frame: 1 hour
Arteria Carbon dioxide tension
Time frame: 1 hour
Tidal volume distribution
Time frame: 1 hour
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 30 Sep 2025.
- Individual participant dataSharing planned: Undecided. Data will be made available upon reasonable request
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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.
Domenico L. Grieco, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS
1 site 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 Acute Hypoxemic Respiratory Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 3 inclusion and 6 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 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 1 site 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?
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?
Inspiratory effort (time frame: 1 hour). 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?
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.