Table 2 Outcomes
Whole cohort (n = 180) | Kalinox® (n = 90) | VR (n = 90) | p value | ||
|---|---|---|---|---|---|
PP | ITT | ||||
Primary outcome | |||||
ΔANI | − 15.38 ± 12.20 | − 15.06 ± 12.85 | − 15.70 ± 11.58 | ||
Secondary outcomes | |||||
Time with ANI > 60 (%) | 83 [43–100] | 77 [39–100] | 85 [44–100] | 0.503 | |
ANI minimal value, n (%): | |||||
ANI < 50 | 56 (31.1) | 30 (33.3) | 26 (28.9) | 0.63 | |
ANI < 40 | 16 (8.9) | 9 (10) | 7 (7.8) | 0.79 | |
NRS pain | |||||
Before procedure | 3.0 [1.0–5.0] | 3.0 [2.0–5.0] | 2.5 [1.0–4.3] | 0.164 | 0.29 |
Immediately after procedure | 4.0 [2.0–6.0] | 3.0 [2.0–6.0] | 5.0 [3.0–7.0] | 0.009 | 0.03 |
10 min after procedure | 2.0 [1.0–3.0] | 1.0 [0.0–2.0] | 2.0 [1.0–3.0] | 0.065 | 0.06 |
NRS anxiety | |||||
Before procedure | 3.0 [1.0–5.0] | 4.0 [1.5–5.0] | 3.0 [1.0–5.0] | 0.407 | |
Immediately after procedure | 3.0 [1.0–5.0] | 3.0 [1.0–5.0] | 3.0 [1.0–6.0] | 0.444 | |
10 min after procedure | 1.0 [0.0–3.0] | 1.0 [0.0–3.0] | 1.0 [0.0–3.0] | 0.785 | |
Morphine use | |||||
Before procedure | 13 (7.2) | 7 (7.8) | 6 (6.7) | 0.773 | |
After procedure | 2 (1.1) | 0 (0.0) | 2 (2.2) | 0.155 | |
Patient satisfaction | 0.002 | ||||
Unsatisfied | 0 (0) | 0 (0) | 0 (0) | – | |
Not very satisfied | 10 (5.6) | 1 (1.1) | 9 (10) | 0.01 | |
Satisfied | 58 (32.2) | 23 (25.6) | 35 (38.9) | 0.06 | |
Very satisfied | 112 (62.2) | 66 (73.3) | 46 (51.1) | 0.002 | |
Nurse satisfaction | 0.69 | ||||
Unsatisfied | 0 (0) | 0 (0) | 0 (0) | – | |
Poorly satisfied | 5 (2.8) | 2 (2.2) | 3 (3.3) | 0.65 | |
Satisfied | 21 (11.6) | 9 (10) | 12 (13.3) | 0.49 | |
Very satisfied | 154 (85.6) | 79 (87.8) | 75 (83.3) | 0.40 | |