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High-flow therapy by nasal cannulae versus high-flow face mask in severe hypoxemia after cardiac surgery: a single-center randomized controlled study -- the HEART FLOW study |
Vourc'h M, Nicolet J, Volteau C, Caubert L, Chabbert C, Lepoivre T, Senage T, Roussel J-C, Rozec B |
Journal of Cardiothoracic and Vascular Anesthesia 2020 Jan;34(1):157-165 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine whether high-flow oxygen therapy by nasal cannulae (HFNC) is more effective than a high-flow face mask (HFFM) in severe hypoxemia. DESIGN: Randomized, single-center, open-labeled, controlled trial. SETTING: University Hospital of Nantes, France. PARTICIPANTS: Cardiac surgery patients presenting oxygen saturation < 96% with Venturi mask 50%. INTERVENTION: Oxygenation by HFNC (45 L/min, FiO2 100%) or Hudson RCI non-rebreather face mask with a reservoir bag (15 L/min). MEASUREMENTS AND MAIN RESULTS: The co-primary outcomes were the PaO2/FiO2 ratio at 1 and 24 hours. In the intent-to-treat analysis (90 patients), the mean (standard deviation) PaO2/FiO2 ratios were: after 1 hour, 113.4 (50.2) in HFFM versus 137.8 (57.0) in HFNC (mean difference 24.4, CI 97.5% 2.9 to 45.9, p = 0.03), and after 24 hours, 106.9 (62.6) in HFFM versus 129.9 (54.0) in HFNC (mean difference 23.0, CI 97.5% 1.5 to 44.6, p = 0.04). After adjustment on baseline PaO2/FiO2) this difference persisted at 24 hours (p = 0.04). For secondary outcomes, the PaO2/FiO2 ratio after 6 hours was 108.7 (47.9) in HFFM versus 136.0 (45.2) in HFNC (p = 0.01), without difference after 48 hours (p = 0.95). Refractory hypoxemia requiring noninvasive ventilation occurred in 13 (28%) patients in HFNC versus 24 (56%) patients in HFFM (p = 0.007). The HFNC improved satisfaction (p = 0.0002) and reduced mucus dryness (p = 0.003) compared with HFFM. CONCLUSION: In patients with severe hypoxemia after cardiac surgery, PaO2/FiO2 at 1 and 24 hours were higher and the use of noninvasive ventilation was reduced in HFNC compared with HFFM.
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