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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04693403
Other study ID # ARISE_001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date January 16, 2024

Study information

Verified date May 2024
Source Makerere University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

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;

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
HFNC
40-60l/min humidified oxygen by nasal cannula
CPAP
Oxygen therapy by boussignac Continuous positive airway pressure face mask
Standard Oxygen
Oxygen therapy by low flow (upto 15l/min) by Non-rebreather face mask

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Makerere University Paris 12 Val de Marne University, THRiVE, Wellcome Trust

Country where clinical trial is conducted

Uganda, 

Outcome

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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