Bag CPAP vs Standard Oxygen Therapy in Acute Hypoxemic Respiratory Failure (BAGCPAP-R)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: Bag CPAP; Device: Standard oxygen

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruce Nzobele MUTEMBE, MD; Phone Number: +250780859127 +250783874050; Email: brucemutembe@gmail.com
• Study Contact Backup: Name: Jean-Paul RWABIHAMA, MD, PhD; Phone Number: +250780859127; Email: jeanpaulrwabihama@gmail.com

Study Locations

• Rwanda
  • Kigali, Rwanda
    • University of Rwanda
    • Contact: Bruce Nzobele MUTEMBE, MD; Phone Number: +250 783 874 050; Email: brucemutembe@gmail.com
    • Contact: Jean Paul RWABIHAMA, MD, PhD; Phone Number: +250 780 859 127; Email: jeanpaulrwabihama@gmail.com
    • Principal Investigator: Bruce Nzobele MUTEMBE, MD
    • Principal Investigator: Christian MUKWESI, MD
    • Principal Investigator: Antoine BAHATI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. 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.
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxygen+Bag CPAP; Patients will receive oxygen and Bag CPAP sessions	Device: Bag CPAP; 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.; Device: Standard oxygen; 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
Active Comparator: Oxygen; Patients will receive oxygen	Device: Standard oxygen; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with criteria for intubation at day 7	Predetermined criteria for endotracheal intubation and mechanical ventilation will be considered.	Day-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of the Bag CPAP	Percentage of patients with facial skin abrasion and necrosis, aspiration, or sinusitis up to day 28.	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.	Up to day-28
Ventilator-free days		up to day-28
Organ failure-free days		Day-7
Mortality rate		Up to day-28
Duration of hospital stay		Up to day-28
Percentage of patients intubated		Day-28

Collaborators and Investigators

• Sponsor: Prof RWABIHAMA Jean Paul
• Investigators: Study Director: Armand Dessap MEKONSTO, MD, PhD, University of Paris-Est Cretel; Study Director: Jean Paul RWABIHAMA, MD,PhD, University of Rwanda; Study Chair: Sabin Nsanzimana, MD, PhD, Ministry of Health, Rwanda

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; CPAP; Respiratory Failure; Low resource setting
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: URICU250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No