Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study.
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.
Gregoretti
Cesare
C
Intensive Care Unit, Azienda Ospedaliera CTO-CRF-ICORMA, Via Zuretti 29, 10100 Turin, Italy. 3358394262@tim.it
Confalonieri
Marco
M
Navalesi
Paolo
P
Squadrone
Vincenzo
V
Frigerio
Pamela
P
Beltrame
Fabio
F
Carbone
Giorgio
G
Conti
Giorgio
G
Gamna
Federica
F
Nava
Stefano
S
Calderini
Edoardo
E
Skrobik
Yoanna
Y
Antonelli
Massimo
M
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*