Under

Lemyze, Malcolm MD1; Mallat, Jihad MD, MSc2; Vangrunderbeek, Nicolas MD3; Granier, Maxime MD1

1 Department of Critical Care Medicine, Arras Hospital, Arras, France.

2 Department of Critical Care Medicine, Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE.

3 Department of Critical Care Medicine, Schaffner Hospital, Lens, France.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website (http://journals.lww.com/ccmjournal).

Dr. Vangrunderbeek disclosed that he gave a lecture/recorded interview with Philips. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Clinical Trial Registration: ClinicalTrials.gov, No.: NCT04102735; https://www.clinicaltrials.gov/ct2/show/NCT04102735?term=NCT04102735.

For information regarding this article, E-mail: [email protected]

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).

A multicenter, prospective randomized controlled study.

Two ICUs from two French tertiary hospitals.

A total of 108 patients needed NIV for AHRF.

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).

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).

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.