Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. The Bag CPAP may be useful in reducing the need for intubation and therefore mortality in patients with AHRF but data are lacking. This study aims to determine whether the Bag CPAP compared to standard oxygen care, could reduce the percentage of patients with criteria for intubation in patients with AHRF.
This is a prospective randomized, open-label, controlled trial in which patients presenting at the emergency room in Rwanda will be randomly assigned to receive standard oxygen therapy or Bag CPAP. The primary endpoint is the percentage of patients with criteria for intubation at day 7. Secondary endpoints include the tolerance of the Bag CPAP, overall 28-day mortality rate, mortality rate of intubated patients on mechanical ventilation at day 28, percentage of patients intubated at 28 days, ventilator-free days at day 28, interval between the initiation of treatment and the onset of intubation criteria, the interval between the time when criteria for intubation are met and intubation, organ failure-free days at day 7 and length of hospital stay.
De novo acute respiratory distress, characterized by the presence of dyspnea at rest, the use of accessory muscles for breathing, or a respiratory rate of 25 cycles per minute or more.
Hypoxemia, defined as a SpO2/FiO2 ratio less than 315 or a PaO2/FiO2 ratio less than 300 mmHg (if arterial blood gas is available) despite an oxygen therapy of 6 L/min. FiO2 will be estimated by the rule of 3% (Coudroy formula)(18,22). SpO2 should be less than 98% when assessing the SpO2/FiO2 ratio.
Absolute contraindications to CPAP: patient's refusal, uncontrollable vomiting, upper gastrointestinal bleeding, open or sucking chest wound, pneumothorax not drained, craniofacial trauma, severe burns to the face, severe upper airway obstruction, traumatic tetraplegia at the initial stage, tracheostomy.
Moderate to massive pleural effusion not drained
Cardiac arrest, severe ventricular arrhythmias, and shock defined as the need for vasopressor support (adrenaline, noradrenaline, or dopamine)
Altered level of consciousness (GCS below 12), repetitive convulsions, or status epilepticus
Parallel
Bag CPAP
DeviceBag CPAP sessions in addition to standard oxygen therapy. The Bag CPAP will be delivered continuously for the first 6 to 12 hours, then for sessions of at least 4 hours per day.
Standard oxygen
DeviceStandard oxygen therapy via nasal prongs, simple facial masks, or non-rebreather masks, depending on the need, until endotracheal intubation, death, or the presence of oxygen therapy cessation criteria
Percentage of patients with criteria for intubation at day 7
Predetermined criteria for endotracheal intubation and mechanical ventilation will be considered.
Tolerance of the Bag CPAP
Percentage of patients with facial skin abrasion and necrosis, aspiration, or sinusitis up to day 28.
Mortality rate of intubated patients on mechanical ventilation
Invasive mechanical ventilation is defined as the delivery of positive pressure via an endotracheal or tracheostomy tube.
Ventilator-free days
Organ failure-free days
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Prof RWABIHAMA Jean Paul
Lead sponsor
University of Rwanda
Sponsor institution
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