An interventional study of Noninvasive ventilation in Acute Hypoxemic Respiratory Failure, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
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).
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 20 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).
Device: Noninvasive ventilation
1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O).
Device: Noninvasive ventilation
1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).
Device: Noninvasive ventilation
noninvasive ventilation
Inspiratory effort
negative deflection in esophageal pressure
Time frame: 1 hour
End-expiratory lung impedance
Electrical-impedance derived end-expiratory lung volume
Time frame: 1 hour
Tidal volume
Electrical-impedance derived tidal volume size
Time frame: 1 hour
Work of breathing
Esophageal pressure simplified pressure-time product
Time frame: 1 hour
Respiratory rate
Respiratory rate per minute
Time frame: 1 hour
Dynamic transpulmonary driving pressure
Tidal change in transpulmonary pressure
Time frame: 1 hour
Compliance
Ratio of tidal volume to transpulmonary driving pressure
Time frame: 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
Time frame: 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
Time frame: 1 hour
Oxygenation
PaO2/FiO2 ratio
Time frame: 1 hour
Pendelluft extent
Pendelluft extent, expressed in % of the total tidal volume
Time frame: 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
Time frame: 1 hour
Arteria Carbon dioxide tension
PaCO2
Time frame: 1 hour
Tidal volume distribution
Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal)
Time frame: 1 hour
Plan to share: Undecided — Data will be made available upon reasonable request
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS