Physiology of Helmet vs. Facemask Noninvasive Ventilation
- Conditions
- Acute Hypoxemic Respiratory Failure
- Interventions
- Device: Noninvasive ventilation
- Registration Number
- NCT06210386
- Brief 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. 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Facemask noninvasive ventilation (helmet settings) Noninvasive ventilation 1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O). Facemask noninvasive ventilation (facemask settings) Noninvasive ventilation 1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O). Helmet noninvasive ventilation Noninvasive ventilation 1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).
- Primary Outcome Measures
Name Time Method Inspiratory effort 1 hour negative deflection in esophageal pressure
End-expiratory lung impedance 1 hour Electrical-impedance derived end-expiratory lung volume
- Secondary Outcome Measures
Name Time Method Tidal volume 1 hour Electrical-impedance derived tidal volume size
Discomfort 1 hour Device-related discomfort (ranging from 0 to 10, with representing most severe dyspnea) rated through a visual analog scale adapted for critically ill patients
Oxygenation 1 hour PaO2/FiO2 ratio
Corrected minute ventilation 1 hour 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
Dynamic transpulmonary driving pressure 1 hour Tidal change in transpulmonary pressure
Work of breathing 1 hour Esophageal pressure simplified pressure-time product
Respiratory rate 1 hour Respiratory rate per minute
Dyspnea 1 hour Dyspnea rated through a visual analog scale (ranging from 0 to 10, with representing most severe dyspnea) adapted for critically ill patients
Tidal volume distribution 1 hour Tidal volume distribution, assessed with electrical impedance tomography in 4 regions of interest (ventral, mid-ventral, mid-dorsal, dorsal)
Pendelluft extent 1 hour Pendelluft extent, expressed in % of the total tidal volume
Compliance 1 hour Ratio of tidal volume to transpulmonary driving pressure
Arteria Carbon dioxide tension 1 hour PaCO2
Trial Locations
- Locations (1)
Fondazione Policlinico Universitaro A. Gemelli IRCCS
🇮🇹Rome, Italy