Adult Respiratory Failure Intervention Study Africa (ARISE-AFRICA)
Acute Respiratory Failure With Hypoxia, Acute Respiratory Distress Syndrome, Acute Lung Injury
About this trial
This is an interventional treatment trial for Acute Respiratory Failure With Hypoxia
Eligibility Criteria
Inclusion Criteria:
- De novo acute respiratory distress, as defined by dyspnea, use of accessory respiratory muscles, and a respiratory rate of 25 breaths per minute or more,
- Hypoxemia, as defined by a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg or a oxygen saturation by pulse oximetry SpO2/FiO2 ratio <315 will be considered for inclusion
- Informed consent obtained in accordance with local regulations;
Exclusion Criteria:
- Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease;
- Absolute contraindications to CPAP or HFNC
- Cardiac arrest; severe ventricular arrhythmia; shock defined by the need for vasopressors (dopamine > 5 microg/kg/min or adrenaline or noradrenaline at any dose)
- Altered consciousness (Coma Glasgow Score below 12 points);
- Do not intubate order, do not resuscitate order, or decision to limit full care taken before obtaining informed consent;
- Refusal to participate, prior enrolment in the trial, participation in another interventional study on respiratory distress;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
High-flow oxygen nasal cannula (HFNC)
Continuous positive airway pressure (CPAP)
Standard Low flow Oxygen Arm
In the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier and applied continuously through large-bore bi-nasal prongs, with a gas flow rate of 40-60 liters per minute and adjusted based on the clinical response.
Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment. CPAP will be started at 7.5 cm of water. The level will be decreased to 5 cm of water or increased to 10 cm of water as needed based on the clinical response and tolerance.
Patients assigned to the standard treatment group will receive oxygen delivered through a Non-rebreather face mask until endotracheal intubation, death, or fulfillment of oxygen delivery cessation criteria (an oxygen saturation by pulse oximetry (SpO2) above 92% without oxygen and a respiratory rate below 25 cycles/min).