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

March 16, 2026 updated by: Prof RWABIHAMA Jean Paul

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Rwanda
      • Kigali, Rwanda
        • University of Rwanda
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruce Nzobele MUTEMBE, MD
        • Principal Investigator:
          • Christian MUKWESI, MD
        • Principal Investigator:
          • Antoine BAHATI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day-7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to day-28
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.
Up to day-28
Ventilator-free days
Time Frame: up to day-28
up to day-28
Organ failure-free days
Time Frame: Day-7
Day-7
Mortality rate
Time Frame: Up to day-28
Up to day-28
Duration of hospital stay
Time Frame: Up to day-28
Up to day-28
Percentage of patients intubated
Time Frame: Day-28
Day-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof RWABIHAMA Jean Paul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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