About this trial
Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation \[3\]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries.
Used of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min
Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.
Disqualifiers
Pregnant or breastfeeding women
Persons deprived of their liberty
Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease
Moderate to large amount of unilateral or bilateral undrained pleural effusion
Trial design
Parallel
Treatments tested in this trial
CPAP
Other interventionContinuous Positive Airway Pressure (CPAP) with Boussignac valve
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with intubation criteria within 7 days
The proportion of patients requiring endotracheal intubation within 7 days after randomization. Intubation will be defined as the insertion of an endotracheal tube for invasive invasive mechanical ventilation
Secondary outcomes
All cause mortality at 28 days
Proportion of patients who have died from any cause within 28 days after randomization. Mortality will be assessed using medical records and/or direct patient follow-up
Organ failure-free days at 7 days
Organ failure will be defined using SOFA score or Modified SOFA score. The score ranges from 0 to 24.
CPAP tolerance Assessment
Patient discomfort will be assessed using a visual analog scale ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort).
Sponsors and contacts
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Université NAZI BONI
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator