title: Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study.
abstract: OBJECTIVE
  To evaluate patient comfort, skin breakdown and eye irritation when comparing a prototype face mask (PM) and conventional face masks (CMs) during non-invasive ventilation.
  
  
  METHODS
  Eight centers (intensive or intermediate care units). Multicenter randomized study.
  
  
  METHODS
  Patients with acute respiratory failure of different etiologies.
  
  
  METHODS
  Patients were randomized to CMs or PM when ventilation was expected to last at least 12 consecutive hours a day for two consecutive days. Patient comfort, skin breakdown and eye irritation, assessed by means of standardized scoring systems, were measured after 24 and 48 h and before discontinuing ventilation.
  
  
  RESULTS
  Hundred ninety-four patients were randomized. Forty-seven patients were finally enrolled: PM (24) and CMs (23). Ventilator settings were similar in the two groups at the beginning of the treatment and after 24 and 48 h. Skin breakdown was significantly higher in the CMs group over the study period ( p<0.001). Patient comfort was higher in the PM group after 24 and 48 h ( p=0.008 and p<0.001, respectively). Eye irritation was absent in both groups after 24 h and did not differ significantly after 48 h (p=0.539). Before ventilation was discontinued skin breakdown and patient comfort were significantly higher in the CMs group, when compared to the PM group ( p<0.001 and p=0.003, respectively). Eye irritation was slightly higher in the PM versus CMs group ( p=0.21). The time on ventilation was not significantly different between the two groups ( p=0.830).
  
  
  CONCLUSIONS
  The PM significantly reduced skin breakdown while improving patient comfort, compared to the CMs.
authors.affiliation: Intensive Care Unit, Azienda Ospedaliera CTO-CRF-ICORMA, Via Zuretti 29, 10100 Turin, Italy. 3358394262@tim.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Gregoretti
authors.forename: Marco
authors.initials: M
authors.lastname: Confalonieri
authors.forename: Paolo
authors.initials: P
authors.lastname: Navalesi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Squadrone
authors.forename: Pamela
authors.initials: P
authors.lastname: Frigerio
authors.forename: Fabio
authors.initials: F
authors.lastname: Beltrame
authors.forename: Giorgio
authors.initials: G
authors.lastname: Carbone
authors.forename: Giorgio
authors.initials: G
authors.lastname: Conti
authors.forename: Federica
authors.initials: F
authors.lastname: Gamna
authors.forename: Stefano
authors.initials: S
authors.lastname: Nava
authors.forename: Edoardo
authors.initials: E
authors.lastname: Calderini
authors.forename: Yoanna
authors.initials: Y
authors.lastname: Skrobik
authors.forename: Massimo
authors.initials: M
authors.lastname: Antonelli
mesh_terms: D018806:APACHE; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008397:Masks / Q000009:adverse effects*; D008875:Middle Aged; D012121:Respiration, Artificial / Q000295:instrumentation*; D012128:Respiratory Distress Syndrome / Q000145:classification / Q000628:therapy*; D012871:Skin Diseases / Q000209:etiology*