Table 2.
Interventions, co-interventions and outcomes among patients in the helmet noninvasive ventilation and usual respiratory support groups
| Variablea | Non-survivors at 180 days | HRQoL respondents | ||
|---|---|---|---|---|
| Helmet noninvasive ventilation (N = 63) | Usual respiratory support (N = 65) | Helmet noninvasive ventilation (N = 96) | Usual respiratory support (N = 93) | |
| Helmet NIV use during the 28-day study period | ||||
| Number of patients, N (%) | 63 (100) | 2 (3.1) | 89 (92.7) | 2 (2.2) |
| Total duration of helmet, median (IQR), hours | 48 (20, 72) | 0 (0, 0) | 34 (16, 58) | 0 (0, 0) |
| Noninvasive respiratory support in the first 48 h | ||||
| Helmet NIV | ||||
| Number of patients, N (%) | 63 (100) | 1 (1.5) | 88 (91.7) | 2 (2.2) |
| Duration of use (hours), median (IQR) | 38 (19, 46) | 0 (0, 0) | 33 (10.5, 45.3) | 0 (0, 0) |
| Mask NIV | ||||
| Number of patients, N (%) | 17 (27) | 44 (67.7) | 26 (27.1) | 65 (69.9) |
| Duration of use (hours), median (IQR) | 0 (0, 5) | 17 (0, 33) | 0 (0, 5.5) | 12 (0, 24) |
| Helmet or mask NIV | ||||
| Number of patients, N (%) | 63 (100) | 44 (67.7) | 91 (94.8) | 65 (69.9) |
| Duration of use (hours), median (IQR), | 42 (28, 48) | 17 (0, 33) | 36 (21.8, 47.5) | 12 (0, 25) |
| High-flow nasal oxygen | ||||
| Number of patients, N (%) | 34 (54) | 52 (80) | 57 (59.4) | 69 (74.2) |
| Duration of use (hours), median (IQR) | 2 (0, 9) | 15.5 (6, 36) | 4 (0, 22) | 26 (2, 40) |
| Standard oxygen | ||||
| Number of patients, N (%) | 9 (14.3) | 9 (13.8) | 16 (16.7) | 22 (23.7) |
| Duration of use (hours), median (IQR) | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) |
| Noninvasive ventilation settings (via helmet or mask), day 1 | ||||
| Highest pressure support level, cmH2O, median (IQR) | 8 (8, 10) | 8 (0, 10) | 8 (6, 10) | 8 (0, 10) |
| Highest PEEP, cmH2O, median (IQR) | 10 (10, 10) | 10 (8, 10) | 10 (10, 10) | 10 (8, 10) |
| Co-interventions during the study period, N (%) | ||||
| Vasopressors/Inotropes | 50 (79.4) | 56 (86.2) | 24 (25) | 23 (24.7) |
| Dexmedetomidine use during noninvasive respiratory supportb | 36 (57.1) | 22 (33.8) | 33 (34.4) | 18 (19.4) |
| Awake prone positioning | 20 (31.7) | 21 (32.3) | 22 (22.9) | 27 (29) |
| Renal replacement therapy | 16 (25.4) | 16 (24.6) | 5 (5.2) | 4 (4.3) |
| Invasive mechanical ventilation | 53 (84.1) | 60 (92.3) | 22 (22.9) | 20 (21.5) |
| Duration of invasive mechanical ventilation, median (IQR) | 10 (6, 18) | 12 (8, 21) | 9 (7, 16) | 12 (7, 23) |
| Therapies received during invasive mechanical ventilation, N (%) | ||||
| Neuromuscular blocker infusion | 37 (58.7) | 39 (60) | 15 (15.6) | 13 (14.0) |
| Prone positioning | 30 (47.6) | 40 (61.5) | 11 (11.5) | 12 (12.9) |
| Recruitment maneuvers | 12 (19.0) | 8 (12.3) | 5 (5.2) | 6 (6.5) |
| Inhaled nitric oxide | 11 (17.5) | 8 (12.3) | 4 (4.2) | 3 (3.2) |
| Tracheostomy | 6 (9.5) | 9 (13.8) | 5 (5.2) | 7 (7.5) |
| ECMO | 3 (4.8) | 2 (3.1) | 1 (1) | 0 (0) |
| COVID-19 therapeutics, N (%) | ||||
| Corticosteroids | 63 (100) | 65 (100) | 96 (100) | 93 (100) |
| Tocilizumab | 45 (71.4) | 27 (41.5) | 59 (61.5) | 53 (57) |
| ICU length of stay (days)c, median (IQR) | 18 (13, 27) | 20 (13, 35) | 9 (6, 14) | 10 (7, 14) |
| Hospital length of stay (days)c, median (IQR) | 20 (14, 32) | 21 (13, 35) | 17 (10, 25) | 14 (10, 22) |
IQR interquartile range, NIV noninvasive ventilation, PEEP positive end-expiratory pressure, ECMO Extracorporeal membrane oxygenation
aAll calculations are provided for all patients in each group, with the exception of noninvasive ventilation (helmet or mask noninvasive ventilation) settings, which were provided for patients receiving noninvasive ventilation (helmet or mask noninvasive ventilation)
bDexmedetomidine was used for comfort and to improve compliance; benzodiazepines and other intravenous sedatives were not used
cICU and hospital length of stay were calculated from the time of randomization to ICU or hospital discharge respectively