TABLE 2

Outcome Variables

VariableSBHelmetSBMaskPa
No. of trial failure, n (%)4 (20)16 (80).0002
Causes of trial failure
    Intolerance, COMFORT score > 26, n (%)1 (5)13 (65).0005
    Air leaks, n (%)3 (15)3 (15).683
    Deterioration in gas exchange, n (%)00.99
    Major adverse events, n (%)00.99
COMFORT score, median (95% CI)21.5 (18–23)23.5 (22–26)21 (18–24)30 (27–34).0011
Application time, median (95% CI), min84 (76–92)15 (12–36).0001
Patients needing sedation, n (%)4 (20)12 (60).004
Cutaneous sores, level 1, n (%)09 (45).009
Gastric distension, n (%)2 (10)3 (15).96
Eye irritation, n (%)00.99
  • CI indicates confidence interval.

  • a P value between interfaces and ANOVA and McNemar's test (see text).