FLORALI study (High-Flow Oxygen Therapy for the Resuscitation of Acute Lung Injury): use of nasal high-flow oxygen therapy in non-hypercapnic acute respiratory failure. Introduction to the study protocol

Abstract

The use of non-invasive ventilation (NIV) in nonimmunosuppressed patients with acute hypoxemic nonhypercapnic respiratory failure is controversial. About 60% of the patients treated with NIV require intubation with a high mortality rate. Nasal high-flow oxygen therapy (NHFO) is a recent device with possible beneficial effects as delivering high FiO₂ and improving comfort between NIV sessions. The FLORALI study aims to evaluate the use of NHFO in non-immunosuppressed patients with acute hypoxemic non-hypercapnic respiratory failure. Patients and methods: we are conducting a randomized multicentric study comparing three strategies of ventilation support in patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure: 1) standard oxygen therapy, 2) NHFO, and 3) NHFO associated with NIV for at least 8 h per day during three days. All patients admitted to the ICU for acute respiratory failure can be included if presenting respiratory rate ≥ 25 breaths per minute, hypoxemia defined by PaO₂/FiO₂ ratio ≤ 300 mmHg using at least 10 l/min oxygen, FiO₂ being measured using an oxygen analyzer located in the mask, and PaCO₂ ≤ 45 mmHg. The main objective is to compare rates of intubation with each of the three tested strategies. A sample of 300 patients (100 patients in each group) is required to detect a 20% reduction in the intubation rate, considering an intubation rate of 60% in the standard group and of 40% in the groups using NHFO. This study is supported by the REVA group.