Adult Respiratory Failure Intervention Study Africa

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure With Hypoxia; Acute Lung Injury
• Interventions: Procedure: Standard Oxygen; Procedure: HFNC; Procedure: CPAP

• Registration Number: NCT04693403
• Lead Sponsor: Makerere University

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.

Study Timeline

• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2023-03-13
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

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;

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Low flow Oxygen Arm	Standard Oxygen	Patients assigned to the standard treatment group will receive oxygen delivered through a Non-rebreather face mask until endotracheal intubation, death, or fulfillment of oxygen delivery cessation criteria (an oxygen saturation by pulse oximetry (SpO2) above 92% without oxygen and a respiratory rate below 25 cycles/min).
High-flow oxygen nasal cannula (HFNC)	HFNC	In the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier and applied continuously through large-bore bi-nasal prongs, with a gas flow rate of 40-60 liters per minute and adjusted based on the clinical response.
Continuous positive airway pressure (CPAP)	CPAP	Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment. CPAP will be started at 7.5 cm of water. The level will be decreased to 5 cm of water or increased to 10 cm of water as needed based on the clinical response and tolerance.

Primary Outcome Measures

Name	Time	Method
Mortality	28 day	Number of study participants deceased at day 28 of study randomisation

Secondary Outcome Measures

Name	Time	Method
Number of patients intubated and ventilator-free	28 days	Number of patients intubated and ventilator-free at 28 days from randomisation
Patient Tolerance to CPAP or HFNC	7 days	Patients will be assessed using the Likert scale
Organ failure free days	7 days	Number of days from randomisation free of organ failure
Number of patients who meet criteria for intubation at day 7	7 days	Number of patients who meet criteria for intubation at day 7 of randomisation

Trial Locations

Locations (17)

Jinja Regional Referral Hospital; 🇺🇬 Jinja, Uganda

Kiruddu National referral Hospital; 🇺🇬 Kampala, Uganda

Naguru Referral Hospital; 🇺🇬 Kampala, Uganda

St Mary's, Lacor; 🇺🇬 Gulu, Uganda

Hoima Regional referral Hospital; 🇺🇬 Hoima, Uganda

Entebbe Regional Referral Hospital; 🇺🇬 Entebbe, Uganda

Kabale Regional Referral Hospital; 🇺🇬 Kabale, Uganda

Nsambya Hospital; 🇺🇬 Kampala, Uganda

Kampala hospital; 🇺🇬 Kampala, Uganda

Mulago National Specialised Hospital; 🇺🇬 Kampala, Uganda

TMR International Hospital; 🇺🇬 Kampala, Uganda

Rubaga 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, Uganda