Adult Respiratory Failure Intervention Study Africa

Acute Respiratory Distress Syndrome Clinical Trial

— ARISE-AFRICA  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693403
• Other study ID #: ARISE_001
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: January 16, 2024

Study information

• Verified date: December 2023
• Source: Makerere University
• Contact: Daphne Kabatooro, MD
• Phone: +256774620752
• Email: karudaph[@]gmail.com
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 504
• 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;

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure With Hypoxia
• Hypoxia
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

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