Status:
COMPLETED
The Acute Respiratory Intervention StudiEs in Africa (ARISE-AFRICA) Study
Lead Sponsor:
Makerere University
Collaborating Sponsors:
THRiVE
Paris 12 Val de Marne University
Conditions:
Acute Respiratory Failure With Hypoxia
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-95 years
Phase:
NA
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 ...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT04693403
Start Date
March 13 2023
End Date
March 31 2024
Last Update
August 14 2025
Active Locations (17)
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1
Entebbe Regional Referral Hospital
Entebbe, Uganda
2
St Mary's, Lacor
Gulu, Uganda
3
Hoima Regional referral Hospital
Hoima, Uganda
4
Jinja Regional Referral Hospital
Jinja, Uganda