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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet noninvasive ventilation | Experimental | 1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). |
|
| Facemask noninvasive ventilation (facemask settings) | Active Comparator | 1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O). |
|
| Facemask noninvasive ventilation (helmet settings) | Active Comparator | 1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive ventilation | Device | noninvasive ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory effort | negative deflection in esophageal pressure | 1 hour |
| End-expiratory lung impedance | Electrical-impedance derived end-expiratory lung volume | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume | Electrical-impedance derived tidal volume size | 1 hour |
| Work of breathing | Esophageal pressure simplified pressure-time product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domenico L. Grieco, MD | Fondazione Policlinico A. Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitaro A. Gemelli IRCCS | Rome | Italy |
Data will be made available upon reasonable request
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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Crossover randomized trial
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| 1 hour |
| Respiratory rate | Respiratory rate per minute | 1 hour |
| Dynamic transpulmonary driving pressure | Tidal change in transpulmonary pressure | 1 hour |
| Compliance | Ratio of tidal volume to transpulmonary driving pressure | 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 | 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 | 1 hour |
| Oxygenation | PaO2/FiO2 ratio | 1 hour |
| Pendelluft extent | Pendelluft extent, expressed in % of the total tidal volume | 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 | 1 hour |
| Arteria Carbon dioxide tension | PaCO2 | 1 hour |
| Tidal volume distribution | Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal) | 1 hour |