Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.
Age≥18 yrs;
A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mm Hg or less, or a ratio of pulse oximetry oxygen saturation (SpO2) to the FiO2 of 315 or less (SpO2≤97%) and the need for (1) noninvasive positive pressure ventilation with at least 5 cm H2O PEEP, or (2) high-flow nasal cannula at 30L/min or higher, or (3) standard oxygen with oxygen flow rate of at least 10 L/min;
Sign informed consent.
Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the screening visit.
Previous bout of mechanical ventilation during index hospitalization.
Exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease.
Moderate to severe cardiac insufficiency (New York Heart Association class >II or left ventricular ejection fraction<50%) or cardiogenic pulmonary edema.
Parallel
Continuous Positive Airway Pressure
Device1. Patients were placed at a 45-degree supine position, and noninvasive ventilation was delivered to the patient through a face mask connected to an ICU ventilator. 2. PEEP was started at 5 cm H2O with a FiO2 of 0.5 at initiation. PEEP and FiO2 were titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min. 3. CPAP was initiated with a first session of at least 4 h, the minimally required duration of noninvasive ventilation was 16 hours per day for at least 2 calendar days. Between noninvasive-ventilation sessions, patients received HFNO.
High-flow nasal oxygen
Device1. Oxygen was passed through a heated humidifier (MR850, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 50 liters per minute and an FiO2 of 0.5 at initiation. HFNO heating temperature was prespecified at 37°C. 2. FiO2 will be titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min. 3. HFNO was applied for at least 2 calendar days.
Non-invasive ventilation
Device1. Patients were placed at a 45-degree supine position, and noninvasive ventilation was also delivered to the patient through a face mask connected to an ICU ventilator. The mask most appropriate for the patient will be selected and adjusted to minimize leakage and pressure points. 2. The inspiratory positive airway pressure (pressure support plus PEEP) was initiated between 12 and 14 cm H2O, PEEP was started at 5 cm H2O with a FiO2 of 0.5 at initiation. FiO2 was titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min. 3. NIV was initiated with a first session of at least 4 h, the minimally required duration of noninvasive ventilation was 16 hours per day for at least 2 calendar days. Between noninvasive-ventilation sessions, patients received HFNO.
Intubation-free survival rate
The proportion of patients who intubation-free and alive within 28 days after randomization.
28-day mortality
The proportion of patients who are died within 28 days
Intubation rate within 28 days
The proportion of patients who are intubated within 28 days after randomization
A ranked composite score incorporating death and intubation through day 28
Priority sequence: 28-day mortality, followed by 28-day intubation
Meeting the prespecified criteria for intubation within 28 days.
The proportion of patients who meeting the prespecified criteria for intubation within 28 days.
Vomiting
The proportion of patients with vomiting, judged by the clinicians according to the clinical manifestations.
Aspiration of gastric contents
The proportion of patients with aspiration of gastric contents, judged by the clinicians according to the clinical manifestations.
Nasal/facial skin necrosis
The proportion of patients with nasal/facial skin necrosis, judged by the clinicians according to the clinical manifestations.
Pneumothorax
Pneumothorax detected through chest X-ray or CT scan
Click on the lead sponsor to view all of their trials.
