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NCT Number: NCT07460427

Bag CPAP vs Standard Oxygen Therapy in Acute Hypoxemic Respiratory Failure

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria

All patients aged 18 years or older will be included in the study if they meet the following criteria:

  • 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.
  • Exclusion criteria

Patients with one of the following criteria will be excluded from the study:

  • 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
  • Do not intubate or resuscitate order before the inclusion in the study
  • Refusal to participate, already included in the study, enrollment in another interventional trial on acute respiratory failure

Treatment and study plan

Bag CPAP

Device

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

Device

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

Primary outcomes

  1. Percentage of patients with criteria for intubation at day 7

    Time frame: Day-7

    Predetermined criteria for endotracheal intubation and mechanical ventilation will be considered.

Secondary outcomes

  1. Tolerance of the Bag CPAP

    Time frame: up to day-28

    Percentage of patients with facial skin abrasion and necrosis, aspiration, or sinusitis up to day 28.

  2. Mortality rate of intubated patients on mechanical ventilation

    Time frame: Up to day-28

    Invasive mechanical ventilation is defined as the delivery of positive pressure via an endotracheal or tracheostomy tube.

  3. Ventilator-free days

    Time frame: up to day-28

  4. Organ failure-free days

    Time frame: Day-7

  5. Mortality rate

    Time frame: Up to day-28

  6. Duration of hospital stay

    Time frame: Up to day-28

  7. Percentage of patients intubated

    Time frame: Day-28

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce Nzobele MUTEMBE, MD

CONTACT

[email protected]

+250783874050 ext. +250780859127

Jean-Paul RWABIHAMA, MD, PhD

CONTACT

[email protected]

+250780859127

Sponsors and collaborators

Lead sponsor

Prof RWABIHAMA Jean Paul

Other

Registry information

Official study title

Bag CPAP Versus Standard Oxygen Care for the Management of Acute Hypoxemic Respiratory Failure in Adults: A Randomized Controlled Trial

Acronym: BAGCPAP-R

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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