Objectives: To determine whether an under-the-nose face mask (FM) as the first-line interface strategy reduces the incidence of facial pressure sores with the same clinical improvement as the one obtained by standard over-the-nose face mask-noninvasive ventilation (FM-NIV) in patients with acute hypercapnic respiratory failure (AHRF).
Design: A multicenter, prospective randomized controlled study.
Setting: Two ICUs from two French tertiary hospitals.
Patients: A total of 108 patients needed NIV for AHRF.
Interventions: participants were randomized (1/1) to receive either the under-the-nose FM (intervention group) or the over-the-nose FM (control group). The primary endpoint was the reduction of facial pressure sores. Secondary endpoints included patients outcome, NIV failure (intubation or death), arterial blood gas improvement, and interface failure (the need to switch to a total face mask).
Measurements and main results: Despite less protective dressings in the intervention group ( n = 4, 5% vs n = 27, 51%; p < 0.001), pressure sores developed less frequently than in the control group ( n = 3, 5% vs n = 39, 74%; p < 0.001). Similar mortality, NIV failure, and arterial blood gas improvement occurred in the two groups. However, under-the-nose FM resulted in a higher interface failure rate than conventional FM ( n = 18, 33% vs n = 5, 9%; p = 0.004), mainly because of excessive unintentional air leaks ( n = 15, 83% vs n = 0, 0%; p < 0.001).
Conclusions: In patients with AHRF, under-the-nose FM significantly reduced the incidence of facial pressure sores compared to the most commonly used first-line interface, the standard FM. However, with this new mask, excessive unintentional air leaks more often compelled the attending clinician to switch to another interface to pursue NIV.
Trial registration: ClinicalTrials.gov NCT04102735.
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