Acute hypoxemic respiratory failure in ICU patients Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult ICU patients with acute hypoxemic respiratory failure requiring supplemental oxygen therapy to maintain PaO2 >60 mmHg or SpO2 >90%, PaCO2 25 breaths/min 3. Acute onset of symptoms within 7 days of hospital admission 4. Age >18 years
Exclusion criteria
Exclusion criteria: 1. Asthma or COPD exacerbation 2. Cardiogenic pulmonary edema 3. Chronic neuromuscular disease 4. Pulmonary embolism 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inspiratory effort measured using Esophageal pressure swing (?Pes) and simplified esophageal pressure–time product per minute (sPTPes/min) measured using esophageal manometry, at each 30-minute intervention phase (HFNC, H-CPAP, HFNC+CPAP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Gas exchange and respiratory mechanics measured using PaO2/FiO2 ratio, venous admixture, PaCO2, respiratory rate, tidal volume, minute ventilation, dynamic transpulmonary driving pressure (?PL), and dynamic lung compliance, at the final 5 minutes of each 30-minute intervention phase.;Ventilatory load measured using the respiratory rate, minute ventilation (Ve), and Ve corrected for PaCO2 at each 30-minute intervention phase;Oxygenation measured using PaO2/FiO2 ratio and venous admixture obtained from arterial blood gas analysis, at the final 5 minutes of each intervention phase;Pneumatic performance of PEEP valves measured using airway pressure swing (?Paw) and correlation between ?Paw and ?Pes using flow-dependent and flow-independent PEEP valves, at H-CPAP and HFNC+CPAP phases;Non-invasive ventilation (NIV) failure measured using data on the need for endotracheal intubation after non-invasive respiratory support, at within 48 hours after study completion;Patient comfort and dyspnea measured using the Borg dyspnea and discomfort scales, at each intervention phase | — |
Countries
Italy