Acute Respiratory Distress Syndrome Clinical Trial
— ARISE-AFRICAOfficial title:
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
Verified date | May 2024 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 705 |
Est. completion date | January 16, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Uganda | Entebbe Regional Referral Hospital | Entebbe | |
Uganda | St Mary's, Lacor | Gulu | |
Uganda | Hoima Regional referral Hospital | Hoima | |
Uganda | Jinja Regional Referral Hospital | Jinja | |
Uganda | Kabale Regional Referral Hospital | Kabale | |
Uganda | Kampala hospital | Kampala | |
Uganda | Kiruddu National referral Hospital | Kampala | |
Uganda | Mulago National Specialised Hospital | Kampala | |
Uganda | Naguru Referral Hospital | Kampala | |
Uganda | Nsambya Hospital | Kampala | |
Uganda | Rubaga Hospital | Kampala | |
Uganda | TMR International Hospital | Kampala | |
Uganda | Kisoro District Hospital | Kisoro | |
Uganda | Masaka regional Referral Hospital | Masaka | |
Uganda | Mbale Regional referral Hospital | Mbale | |
Uganda | Mbarara Regional referral Hospital | Mbarara | |
Uganda | Mengo Hospital | Mengo |
Lead Sponsor | Collaborator |
---|---|
Makerere University | Paris 12 Val de Marne University, THRiVE, Wellcome Trust |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Number of study participants deceased at day 28 of study randomisation | 28 day | |
Secondary | Number of patients intubated and ventilator-free | Number of patients intubated and ventilator-free at 28 days from randomisation | 28 days | |
Secondary | Patient Tolerance to CPAP or HFNC | Patients will be assessed using the Likert scale | 7 days | |
Secondary | Organ failure free days | Number of days from randomisation free of organ failure | 7 days | |
Secondary | Number of patients who meet criteria for intubation at day 7 | Number of patients who meet criteria for intubation at day 7 of randomisation | 7 days |
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