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

A Multicentre, Randomized, Clinical Trial of Respiratory Support With Standard Low Flow Oxygen Therapy, Continuous Positive Airway Pressure, and High-flow Oxygen Therapy in Adults With Acute Hypoxemic Respiratory Failure in Uganda

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693403
Acronym
ARISE-AFRICA
Enrollment
705
Registered
2021-01-05
Start date
2023-03-13
Completion date
2024-03-31
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure With Hypoxia, Acute Respiratory Distress Syndrome, Acute Lung Injury

Keywords

Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome, CPAP, HFNC, Low Income Countries

Brief 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?

Detailed 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.

Interventions

PROCEDUREHFNC

40-60l/min humidified oxygen by nasal cannula

PROCEDURECPAP

Oxygen therapy by boussignac Continuous positive airway pressure face mask

Oxygen therapy by low flow (upto 15l/min) by Non-rebreather face mask

Sponsors

THRiVE
CollaboratorUNKNOWN
Paris 12 Val de Marne University
CollaboratorOTHER
Wellcome Trust
CollaboratorOTHER
Makerere University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Stepped wedge cluster randomised trial (8 Clusters).

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* De novo acute respiratory distress, as defined by dyspnea, use of accessory respiratory 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 oxygen saturation by pulse oximetry SpO2/FiO2 ratio \<315 will be considered for inclusion * Informed consent obtained in accordance with local regulations;

Exclusion criteria

* Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease; * Absolute contraindications to CPAP or HFNC * Cardiac arrest; severe ventricular arrhythmia; shock defined by the need for vasopressors (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 care taken before obtaining informed consent; * Refusal to participate, prior enrolment in the trial, participation in another interventional study on respiratory distress;

Design outcomes

Primary

MeasureTime frameDescription
Mortality28 dayNumber of study participants deceased at day 28 of study randomisation

Secondary

MeasureTime frameDescription
Number of patients intubated and ventilator-free28 daysNumber of patients intubated and ventilator-free at 28 days from randomisation
Patient Tolerance to CPAP or HFNC7 daysPatients will be assessed using the Likert scale
Organ failure free days7 daysNumber of days from randomisation free of organ failure
Number of patients who meet criteria for intubation at day 77 daysNumber of patients who meet criteria for intubation at day 7 of randomisation

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026