Treatment compliance | Sham (N = 10) | Active (N = 10) | Total (N = 20) |
---|---|---|---|
Total sessions, n | 103 | 169 | 272 |
30-min sessions completed, n (% of total sessions) | 98 (95.1) | 147 (87) | 245 (91.1) |
Reasons for early stop of current sessiona, % (n/N) | |||
Heart rate < 40 bpm | 0 (0/103) | 0 (0/169) | 0 (0/272) |
Heart rate > 130 bpm | 1 (1/103) | 0.6 (1/169) | 0.7 (2/272) |
MAP < 60 mmHg | 0 (0/103) | 0 (0/169) | 0 (0/272) |
MAP > 110 mmHg | 1.9 (2/103) | 6.5* (11/169) | 4.8 (13/272) |
Respiratory rate > 40 breaths/min | 1 (1/103) | 3 (5/169) | 2.2 (6/272) |
SpO2 < 90% | 1 (1/103) | 0 (0/169) | 0.4 (1/272) |
Behavior pain scale > 4 | 0 (0/103) | 0.6 (1/169) | 0.4 (1/272) |
Patient request to stop | 0 (0/103) | 2.4 (4/169) | 1.5 (4/272) |
Treatment days from intent-to-treat set, % (median (q1–q3)) | 100 (69–100) | 89 (50–100) | 100 (50–100) |
Reasons for treatment stop before extubation, patients % (n/N) | |||
Discomfort | 10 (1/10) | 10 (1/10) | 10 (2/20) |
Switch to NAVA modeb | 10 (1/10) | 20 (2/10) | 15 (3/20) |
Patient request to stop | 0 (0/10) | 10 (1/10) | 5 (1/20) |
Safetyc | Event | Patient % (n/N) | Event | Patient % (n/N) | Event | Patient % (n/N) |
---|---|---|---|---|---|---|
Adverse events (any) | 11 | 80 (8/10) | 17 | 60 (6/10) | 28 | 70 (14/20) |
Unanticipated adverse device effects | 0 | 0 (0/10) | 9 | 40 (4/10) | 9 | 20 (4/20) |
AEs leading to discontinuation of current FES sessiond or study | 8 | 60 (6/10) | 14 | 50 (5/10) | 22 | 55 (11/20) |
Serious AEs—total | 7 | 60 (6/10) | 3 | 20 (2/10) | 10 | 40 (8/20) |
Serious AEs—deaths | 5 | 50 (5/10) | 1 | 10 (1/10) | 6 | 30 (6/20) |
Intervention-related adverse eventse | 3 | 10 (1/10) | 13 | 50 (5/10) | 16 | 30 (6/20) |
Unanticipated adverse device effects | 0 | 0 (0/10) | 9 | 40 (4/10) | 9 | 20 (4/20) |
AEs leading to discontinuation of current FES sessiond or study | 3 | 10 (1/10) | 11 | 50 (5/10) | 14 | 30 (6/20) |
Serious AEs—total | 0 | 0 (0/10) | 0 | 0 (0/10) | 0 | 0 (0/20) |
Serious AEs—deaths | 0 | 0 (0/10) | 0 | 0 (0/10) | 0 | 0 (0/20) |