Continous Positive Airway Pressure (CPAP) Support for Acute Hypoxemic Respiratory Failure in Burkina Faso

NCT06912360 | Recruiting

• 1 other identifier: INSSA 4
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation \[3\]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries. Used of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.

Conditions

Acute Respiratory Failure

Keywords

CPAP; Acute hypoxemic respiratory failure; Africa

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with intubation criteria within 7 days

  The proportion of patients requiring endotracheal intubation within 7 days after randomization. Intubation will be defined as the insertion of an endotracheal tube for invasive invasive mechanical ventilation

  7 days after randomization

Secondary Outcomes (3)

• All cause mortality at 28 days

  28 days after randomization

• Organ failure-free days at 7 days

  7 days after randomization

• CPAP tolerance Assessment

  7 days after intiation CPAP

Study Arms (2)

CPAP group

EXPERIMENTAL

Continuous CPAP (with Boussignac valve) for the first 6-12 hours, then alternating with standard oxygen therapy. CPAP pressure= 7.5 cmH2O (25L/min) then variations of +/- 2.5 cmH20 according to clinical response and tolerance until weaning from oxygen or presence of intubation criteria

Other: CPAP

Standard group

NO INTERVENTION

Oxygen therapy as required using, simple face masks or high concentration face masks until there are criteria for intubation, or withdrawal from oxygen.

Interventions

CPAP OTHER

Continuous Positive Airway Pressure (CPAP) with Boussignac valve

CPAP group

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 and older will be included in the study if they meet at least one of the following criteria :
• Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min
• Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.

You may not qualify if:

• Patients with any of the following criteria will not be included in the study:
• Pregnant or breastfeeding women
• Persons deprived of their liberty
• Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease
• Moderate to large amount of unilateral or bilateral undrained pleural effusion
• Contraindication to CPAP: patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or tetraplegia in the initial phase
• Cardiac arrest, severe arrhythmias, shock requiring the use of vasopressors (norepinephrine, adrenaline, dopamine)
• Altered level of consciousness (Glasgow Coma Scale score \< 13), repeated seizures, or status epilepticus
• Medical decision to limit treatment: no intubation, no admission to intensive care
• Refusal to participate in the study or participation in another interventional study on respiratory distress or acute respiratory failure.

Sponsors & Collaborators

• Université NAZI BONI: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (4)

Centre Hospitalier Universitaire Souro Sanou

Bobo-Dioulasso, Houet, 01 BP 676, Burkina Faso

RECRUITING

CHU Yalgado Ouedraogo

Ouagadougou, Kadiogo, 03 BP 702250311655, Burkina Faso

NOT YET RECRUITING

CHU Tengandogo

Ouagadougou, Kadiogo, 03 BP 7067, Burkina Faso

NOT YET RECRUITING

CHU Bogodogo

Ouagadougou, Kadiogo, 14 BP 371, Burkina Faso

NOT YET RECRUITING

Related Publications (5)

• Markou NK, Myrianthefs PM, Baltopoulos GJ. Respiratory failure: an overview. Crit Care Nurs Q. 2004 Oct-Dec;27(4):353-79. doi: 10.1097/00002727-200410000-00006.

  PMID: 15537123 RESULT

• Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Steingrub JS, Lagu T, Lindenauer PK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med. 2013 Feb;8(2):76-82. doi: 10.1002/jhm.2004. Epub 2013 Jan 18.

  PMID: 23335231 RESULT

• SRLF Trial Group. Hypoxemia in the ICU: prevalence, treatment, and outcome. Ann Intensive Care. 2018 Aug 13;8(1):82. doi: 10.1186/s13613-018-0424-4.

  PMID: 30105416 RESULT

• Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028.

  PMID: 35072713 RESULT

• Templier F, Dolveck F, Baer M, Chauvin M, Fletcher D. [Laboratory testing measurement of FIO2 delivered by Boussignac CPAP system with an input of 100% oxygen]. Ann Fr Anesth Reanim. 2003 Feb;22(2):103-7. doi: 10.1016/s0750-7658(02)00859-6. French.

  PMID: 12706763 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Armand Mekontso-dessap, professor

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

• Ismael Guibla, doctor

  University Hospital Souro Sanou, Burkina Faso

  PRINCIPAL INVESTIGATOR

• Ibrahim Alain Traore, professor

  University Hospital Souro Sanou, Burkina Faso

  STUDY DIRECTOR

Central Study Contacts

Ismael Guibla, doctor

CONTACT

+22676135113; ismaelguibla@gmail.com

Ibrahim Alain Traore, professor

CONTACT

+22671457580; itraore80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical doctor

Model Details: We will have two groups : an interventional group and a standard of care group

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 4, 2025
• Study Start: July 9, 2025
• Primary Completion: January 20, 2026
• Study Completion: February 20, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (4)