An interventional study of Bag CPAP and Standard oxygen in Acute Hypoxemic Respiratory Failure, sponsored by Prof RWABIHAMA Jean Paul. Not yet recruiting at 1 site in Rwanda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Prof RWABIHAMA Jean Paul · Not applicable, Interventional, and Treatment
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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →This is the only study on the registry with Prof RWABIHAMA Jean Paul as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients aged 18 years or older will be included in the study if they meet the following criteria:
Patients with one of the following criteria will be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive oxygen and Bag CPAP sessions
Device: Bag CPAP · Device: Standard oxygen
Patients will receive oxygen
Device: Standard oxygen
Bag 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 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.
Time frame: Day-7
Tolerance of the Bag CPAP
Percentage of patients with facial skin abrasion and necrosis, aspiration, or sinusitis up to day 28.
Time frame: 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.
Time frame: Up to day-28
Ventilator-free days
Time frame: up to day-28
Organ failure-free days
Time frame: Day-7
Mortality rate
Time frame: Up to day-28
Duration of hospital stay
Time frame: Up to day-28
Percentage of patients intubated
Time frame: Day-28
Plan to share: No
Start is estimated for Apr 2026; primary completion for Feb 2027, 10 months later.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 10 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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