Continous Positive Airway Pressure (CPAP) Support for Acute Hypoxemic Respiratory Failure in Burkina Faso

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité NAZI BONI

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CPAP

    Other intervention

    Continuous Positive Airway Pressure (CPAP) with Boussignac valve

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: CPAP groupExperimental treatment 1 intervention
Group B: Standard groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
7 days after randomization

Secondary outcomes

1

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

Time frame
28 days after randomization
2

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.

Time frame
7 days after randomization
3

CPAP tolerance Assessment

Patient discomfort will be assessed using a visual analog scale ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort).

Time frame
7 days after intiation CPAP

Other outcomes

Sponsors and contacts

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Université NAZI BONI

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Collaborator