The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure
Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy.. Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment. Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one. Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and \>200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently. Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each. At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Noninvasive respiratory support respiratory support
Noninvasive respiratory support respiratory support
Noninvasive respiratory support respiratory support
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
Inspiratory effort
The negative deflection in esophageal pressure during inspiration
Time frame: 40 minutes
Tidal volume
The tidal change in lung impedance, assessed by electrical impedance tomography
Time frame: 40 minutes
Oxygenation
Ratio of PaO2 to FiO2
Time frame: 40 minutes
Tidal volume distribution
Distribution of tidal volume within the lung regions, assessed by electrical impedance tomography
Time frame: 40 minutes
Carbon dioxide
Blood carbon dioxide, measured with the arterial blood gas analysis
Time frame: 40 minutes
Respiratory rate
Respiratory rate/minute, assessed with the esophageal pressure
Time frame: 40 minutes
Dyspnea
Dyspnea assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of dyspnea
Time frame: 40 minutes
Comfort
Comfort assessed with the visual analog scale, 0-10 scale where the highest value corresponds to the highest degree of discomfort
Time frame: 40 minutes
Global impedance-derived End-expiratory lung volume
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End-expiratory lung volume, measured with electrical impedance tomography
Time frame: 40 minutes
Regional impedance-derived End-expiratory lung volume
End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Time frame: 40 minutes
Dynamic transpulmonary driving pressure
The tidal change in transpulmonary pressure
Time frame: 40 minutes
Global impedance-derived lung dynamic strain
Change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography
Time frame: 40 minutes
Regional impedance-derived lung dynamic strain
Change in impedance due to tidal volume / end expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography
Time frame: 40 minutes
Respiratory system dynamic compliance
Ratio of the tidal change in lung impedance to dynamic transpulmonary driving pressure
Time frame: 40 minutes
Pendelluft
Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration
Time frame: 40 minutes
Work of breathing
Esophageal pressure simplified pressure time product per minute
Time frame: 40 minutes