Acute Hypoxic Respiratory FailureNCT06202144
Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure
A study testing Noninvasive support in people with Acute Hypoxic Respiratory Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxic Respiratory Failure
- What is being tested?
- Noninvasive support
- 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
- 12 Jan 2024to 15 Jun 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 support
- 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 Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure
The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals.
The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.
Read the detailed description
Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O.
Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.
- Conditions
- Acute Hypoxic Respiratory Failure
- Being tested
- Noninvasive support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive supportDevice
Noninvasive respiratory support delivered through a helmet
| Study group | Role | What they receive |
|---|---|---|
| Personalized Noninvasive support | Experimental | Helmet noninvasive support, with positive end-expiratory pressure (PEEP)=12 cmH2O and the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O Receives: Device: Noninvasive support |
| Continuous positive airway pressure | Active comparator | Helmet CPAP will be delivered through a high-flow generator and PEEP valve set at 12 cmH2O Receives: Device: Noninvasive support |
| Noninvasive ventilation | Active comparator | Helmet NIV will be delivered in the pressure-support mode, with PEEP=12 cmH2O and pressure support=12 cmH2O Receives: Device: Noninvasive support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Tidal volume size, assessed with electrical impedance tomography
Measured: 1 hour
Transpulmonary driving pressure
The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure
Measured: 1 hour
Secondary outcomes (10)
Inspiratory effort
Inspiratory effort, defined as the negative deflection in esophageal pressure
Measured: 1 hour
Respiratory rate
Respiratory rate per minute
Measured: 1 hour
Blood oxygenation
PaO2/FiO2 ratio
Measured: 1 hour
Work of breathing
Simplified esophageal pressure pressure-time product
Measured: 1 hour
Corrected minute ventilation
Minute ventilation (assessed with electrical impedance tomography) normalized to PaCO2
Measured: 1 hour
Tidal volume distribution
Tidal volume distribution in the four lung regions of interest (ventral, mid-ventral, mid-dorsal and dorsal), assessed with electrical impedance tomography
Measured: 1 hour
End-expiratory lung impedance
End-expiratory lung impedance, assessed with electrical impedance tomography
Measured: 1 hour
Pendelluft extent
Pendelluft, assessed with electrical impedance tomography and expressed in % of tidal volume size
Measured: 1 hour
Lung compliance
Defined as the ration of tidal volume to transpulmonary driving pressure
Measured: 1 hour
Dyspnea
Dyspnea, defined through a visual analog scale ((ranging from 0 to 10, with representing most severe dyspnea)
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 posted11 Jan 2024
- Study start12 Jan 2024
- Primary completion1 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxic 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico Luca Grieco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202144
- Sponsor's protocol ID
- 5173-2
- 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 Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06202144
- Acronym / sponsor ID
- 5173-2
- Conditions
- Acute Hypoxic 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
- 12 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 11 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 respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals.
The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.
Detailed description
Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O.
Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Noninvasive support | Experimental | Device: Noninvasive supportHelmet noninvasive support, with positive end-expiratory pressure (PEEP)=12 cmH2O and the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O |
| Continuous positive airway pressure | Active comparator | Device: Noninvasive supportHelmet CPAP will be delivered through a high-flow generator and PEEP valve set at 12 cmH2O |
| Noninvasive ventilation | Active comparator | Device: Noninvasive supportHelmet NIV will be delivered in the pressure-support mode, with PEEP=12 cmH2O and pressure support=12 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 support
- 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 supportNoninvasive respiratory support delivered through a helmet | Device | Continuous positive airway pressure, Noninvasive ventilation, Personalized Noninvasive support |
Primary outcome
Tidal volume
Time frame: 1 hour
Tidal volume size, assessed with electrical impedance tomography
Transpulmonary driving pressure
Time frame: 1 hour
The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure
10 secondary outcomes
Inspiratory effort
Time frame: 1 hour
Respiratory rate
Time frame: 1 hour
Blood oxygenation
Time frame: 1 hour
Work of breathing
Time frame: 1 hour
Corrected minute ventilation
Time frame: 1 hour
Tidal volume distribution
Time frame: 1 hour
End-expiratory lung impedance
Time frame: 1 hour
Pendelluft extent
Time frame: 1 hour
Lung compliance
Time frame: 1 hour
Dyspnea
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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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure
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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 Luca Grieco principal investigator
Fondazione Policlinico Universitario Agostino 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 support in people with Acute Hypoxic 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?
Tidal volume (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.