The Acute Respiratory Intervention StudiEs in Africa (ARISE-AFRICA) Study

Last updated: August 11, 2025
Sponsor: Makerere University
Overall Status: Completed

Phase

N/A

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Treatment

HFNC

CPAP

Standard Oxygen

Clinical Study ID

NCT04693403
ARISE_001
  • Ages 18-95
  • All Genders

Study Summary

The dearth of Intensive care units in low resource settings portends for poor outcomes amongst patients with acute hypoxemic respiratory failure (AHRF) . To our knowledge, the effect of CPAP and HFNC on major outcomes has not been assessed in adults with AHRF in resource-limited settings. The aim of this prospective, multicenter, randomized, controlled, trial is to determine whether High-flow oxygen through a nasal cannula (HFNC) or Continuous positive airway pressure (CPAP) system can reduce mortality among patients with acute hypoxemic respiratory failure (AHRF) in a limited resource setting as compared with standard low flow oxygen therapy?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • De novo acute respiratory distress, as defined by dyspnea, use of accessoryrespiratory muscles, and a respiratory rate of 25 breaths per minute or more,

  • Hypoxemia, as defined by a ratio of the partial pressure of arterial oxygen (PaO2)to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg or a oxygensaturation by pulse oximetry SpO2/FiO2 ratio <315 will be considered for inclusion

  • Informed consent obtained in accordance with local regulations;

Exclusion

Exclusion Criteria:

  • Exacerbation of asthma, chronic obstructive pulmonary disease or another known orsuspected chronic respiratory disease;

  • Absolute contraindications to CPAP or HFNC

  • Cardiac arrest; severe ventricular arrhythmia; shock defined by the need forvasopressors (dopamine > 5 microg/kg/min or adrenaline or noradrenaline at any dose)

  • Altered consciousness (Coma Glasgow Score below 12 points);

  • Do not intubate order, do not resuscitate order, or decision to limit full caretaken before obtaining informed consent;

  • Refusal to participate, prior enrolment in the trial, participation in anotherinterventional study on respiratory distress;

Study Design

Total Participants: 705
Treatment Group(s): 3
Primary Treatment: HFNC
Phase:
Study Start date:
March 13, 2023
Estimated Completion Date:
March 31, 2024

Study Description

The care for the critically ill patient typically takes place in the intensive care unit (ICU). ICU care is quite expensive, even in resource rich countries. The most common reason for ICU admission globally is respiratory support for acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality, especially in low income countries (LICs), given the scarce availability of invasive mechanical ventilation. Some studies suggest that administration of ventilatory support through a mask may be effective in resource-limited settings. However, there is no clinical study data in adults to support this evidence. Human and material constraints are major barriers for the care of critically-ill patients in resource limited settings , advocating the need for a frugal approach. Furthermore, the scarcity of intensive care unit care in LICs contributes to a high mortality among acutely ill patients. The current corona virus pandemic has further highlighted the need for frugal acute care interventions in LICs.

Continuous positive airway pressure (CPAP) is a simple to use and affordable technique for noninvasive ventilatory support. High-flow oxygen through a nasal cannula (HFNC) may also offer an alternative in patients with hypoxemia. The high flow rates may also decrease physiological dead space by flushing expired carbon dioxide from the upper airway, a process that potentially explains the observed decrease in the work of breathing.

Frugal CPAP or HFNC , as compared with standard oxygen therapy, could reduce the mortality among adults presenting with AHRF in a resource-limited setting.

Connect with a study center

  • Entebbe Regional Referral Hospital

    Entebbe,
    Uganda

    Site Not Available

  • St Mary's, Lacor

    Gulu,
    Uganda

    Site Not Available

  • Hoima Regional referral Hospital

    Hoima,
    Uganda

    Site Not Available

  • Jinja Regional Referral Hospital

    Jinja,
    Uganda

    Site Not Available

  • Kabale Regional Referral Hospital

    Kabale,
    Uganda

    Site Not Available

  • Kampala hospital

    Kampala,
    Uganda

    Site Not Available

  • Kiruddu National referral Hospital

    Kampala,
    Uganda

    Site Not Available

  • Mulago National Specialised Hospital

    Kampala, 00256
    Uganda

    Site Not Available

  • Naguru Referral Hospital

    Kampala,
    Uganda

    Site Not Available

  • Nsambya Hospital

    Kampala,
    Uganda

    Site Not Available

  • Rubaga Hospital

    Kampala,
    Uganda

    Site Not Available

  • TMR International Hospital

    Kampala,
    Uganda

    Site Not Available

  • Kisoro District Hospital

    Kisoro,
    Uganda

    Site Not Available

  • Masaka regional Referral Hospital

    Masaka,
    Uganda

    Site Not Available

  • Mbale Regional referral Hospital

    Mbale,
    Uganda

    Site Not Available

  • Mbarara Regional referral Hospital

    Mbarara,
    Uganda

    Site Not Available

  • Mengo Hospital

    Mengo,
    Uganda

    Site Not Available

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