Bag CPAP vs Standard Oxygen Therapy in Acute Hypoxemic Respiratory Failure

NCT07460427 | Not Yet Recruiting DMC

• 1 other identifier: URICU250
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

CPAP; Randomized controlled trial; Respiratory Failure; Low resource setting

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with criteria for intubation at day 7

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

  Day-7

Secondary Outcomes (7)

• Tolerance of the Bag CPAP

  up to day-28

• Mortality rate of intubated patients on mechanical ventilation

  Up to day-28

• Ventilator-free days

  up to day-28

• Organ failure-free days

  Day-7

• Mortality rate

  Up to day-28

Study Arms (2)

Oxygen+Bag CPAP

EXPERIMENTAL

Patients will receive oxygen and Bag CPAP sessions

Device: Bag CPAP; Device: Standard oxygen

Oxygen

ACTIVE COMPARATOR

Patients will receive oxygen

Device: Standard oxygen

Interventions

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.

Oxygen+Bag CPAP

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

Oxygen; Oxygen+Bag CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Refusal to participate, already included in the study, enrollment in another interventional trial on acute respiratory failure

Sponsors & Collaborators

• Prof RWABIHAMA Jean Paul: lead

Study Sites (1)

University of Rwanda

Kigali, Rwanda

Location

Related Publications (3)

• de Beaufort E, Carteaux G, Morin F, Lesimple A, Haudebourg AF, Fresnel E, Duval D, Broc A, Mercat A, Brochard L, Savary D, Beloncle F, Mekontso Dessap A, Richard JC. A new reservoir-based CPAP with low oxygen consumption: the Bag-CPAP. Crit Care. 2023 Jul 4;27(1):262. doi: 10.1186/s13054-023-04542-2.

  PMID: 37403149 BACKGROUND

• Kwizera A, Nakibuuka J, Nakiyingi L, Sendagire C, Tumukunde J, Katabira C, Ssenyonga R, Kiwanuka N, Kateete DP, Joloba M, Kabatoro D, Atwine D, Summers C. Acute hypoxaemic respiratory failure in a low-income country: a prospective observational study of hospital prevalence and mortality. BMJ Open Respir Res. 2020 Nov;7(1):e000719. doi: 10.1136/bmjresp-2020-000719.

  PMID: 33148779 BACKGROUND

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Armand Dessap MEKONSTO, MD, PhD

  University of Paris-Est Cretel

  STUDY DIRECTOR

• Jean Paul RWABIHAMA, MD,PhD

  University of Rwanda

  STUDY DIRECTOR

• Sabin Nsanzimana, MD, PhD

  Ministry of Health, Rwanda

  STUDY CHAIR

Central Study Contacts

Bruce Nzobele MUTEMBE, MD

CONTACT

+250783874050; brucemutembe@gmail.com

Jean-Paul RWABIHAMA, MD, PhD

CONTACT

+250780859127; jeanpaulrwabihama@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Group oxygen vs Group oxygen+Bag CPAP

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 10, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)