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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facemask 'Nivairo' | Active Comparator | Oronasal mask for 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 |
|
| Facemask 'Optiniv' | Experimental | Facemask for noninvasive ventilation favoring carbon dioxide washout |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive ventilation | Device | Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic work of breathing | Simplified pressure-time-product per minute of the transdiaphragmatic pressure | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Normalized metabolic work of breathing | Simplified pressure-time-product per minute of the transdiaphragmatic pressure normalized to arterial carbon dioxide divided by 45 mmHg | 45 minutes |
| Inspiratory effort, expressed in cmH2O |
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Inclusion Criteria:
Acute respiratory failure with
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico Luca Grieco, MD | Contact | +39063015 | 4490 | domenicoluca.grieco@unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Antonelli, MD | Catholic University of the Sacred Heart | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS | Recruiting | Roma | Italy |
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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 |
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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Positive inspiratory deflection of transdiaphragmatic pressure
| 45 minutes |
| Corrected minute ventilation | Minute ventilation assessed with electrical impedence tomography, normalized to normalized to arterial carbon dioxide divided by 45 mmHg | 45 minutes |
| Dyspnea | Dyspnoea, defined according to visual analog scale of dyspnea (0-10, where 10 represents worst perceivable dyspnea). | 45 minutes |
| Discomfort | Discomfort, defined according to visual analog scale of discomfort (0-10, where 10 represents worst perceivable discomfort). | 45 minutes |
| End-expiratory lung volume | Global impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography | 45 minutes |
| Regional End-expiratory lung volume | Regional (ventral-midventral-middorsal-dorsal) impedance-derived end-expiratory lung volume (EELI), measured with electrical impedance tomography | 45 minutes |
| Arterial carbon dioxide, expressed in mmHg | Arterial carbon dioxide, measured with arterial blood gas analysis | 45 minutes |
| Arterial acid-base state | Arterial pH, measured with arterial blood gas analysis | 45 minutes |
| Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure | Expiratory increases in gastrinc pressure | 45 minutes |
| Tidal volume distribution | Tidal volume distribution in the different lung regions (ventral-midventral-middorsal-dorsal),assessed with electrical impedance tomography | 45 minutes |
| Fondazione Policlinico Universitaro A. Gemelli IRCCS | Recruiting | Rome | Italy |
|