Table 2. Primary and Secondary Outcomes in the HFNC vs CPAP Groups.
| Outcomes | HFNC | CPAP | Difference (95% CI) | Effect estimate (95% CI) | |
|---|---|---|---|---|---|
| Unadjusteda | Adjustedb | ||||
| Primary analysis | |||||
| Total No. analyzed | 295 | 278 | |||
| Primary outcome | |||||
| Time from randomization to liberation from respiratory support, median (95% CI), h | 52.9 (46.0-60.9) | 47.9 (40.5-55.7) | AD, −5.0 (−10.1 to 17.4) | HR, 1.03 (0.87-1.22) | HR, 1.03 (0.86 to 1.22) |
| Secondary outcomes | |||||
| Mortality at critical care unit discharge, No./total (%) | 5/292 (1.7) | 4/274 (1.5) | AD, 0.3 (−1.8 to 2.3) | OR, 1.18 (0.31-4.43) | OR, 1.22 (0.32 to 4.62) |
| Intubation at 48 h, No./total (%) | 45/292 (15.4) | 44/276 (15.9) | AD, −0.5 (−6.5 to 5.5) | OR, 0.96 (0.61-1.51) | OR, 0.99 (0.61 to 1.62) |
| Duration of critical care unit stay, mean (SD), d | 5.0 (8.2) [n = 288] | 7.4 (18.9) [n = 270] | MD, −2.4 (−4.8 to 0.0) | MD, −3.0 (−5.1 to −1.0) | |
| Duration of acute hospital stay, mean (SD), d | 13.8 (26.8) [n = 279] | 19.5 (47.7) [n = 260] | MD, −5.7 (−12.2 to 0.8) | MD, −7.6 (−13.2 to −1.9) | |
| COMFORT Behavior Scale score, mean (SD)c | |||||
| While receiving randomized treatment | 14.1 (3.6) [n = 194] | 14.4 (4.8) [n = 142] | MD, −0.4 (−1.3 to 0.5) | MD, −0.6 (−1.4 to 0.2) | |
| While receiving HFNC or CPAP | 13.9 (3.5) [n = 201] | 13.7 (3.7) [n = 169] | MD, 0.2 (−0.6 to 0.9) | MD, 0.2 (−0.5 to 0.8) | |
| Use of sedation during noninvasive respiratory support, No./total (%) | 81/292 (27.7) | 97/262 (37.0) | AD, −9.3 (−17.1 to −1.5) | OR, 0.65 (0.46-0.93) | OR, 0.59 (0.39 to 0.88) |
| Parental stress score at time of consent, mean (SD)d | 1.5 (0.8) [n = 180] | 1.6 (0.7) [n = 185] | MD, 0.0 (−0.2 to 0.1) | MD, −0.1 (−0.2 to 0.1) | |
| Per-protocol analysis | |||||
| Total No. analyzed | 288 | 245 | |||
| Primary outcome | |||||
| Time from randomization to liberation from respiratory support, median (95% CI), h | 52.7 (45.0-60.1) | 45.4 (40.2-53.7) | AD, 7.3 (−7.3 to 22.2) | 1.05 (0.88-1.25) | 1.03 (0.86 to 1.23) |
| Secondary outcomes | |||||
| Mortality at critical care unit discharge, No./total (%) | 5/285 (1.8) | 3/243 (1.2) | AD, 0.5 (−1.5 to 2.6) | OR, 1.43 (0.34-6.04) | OR, 1.46 (0.35 to 6.22) |
| Intubation at 48 h, No./total (%) | 43/285 (15.1) | 36/243 (14.8) | AD, 0.3 (−5.8 to 6.4) | OR, 1.02 (0.63-1.65) | OR, 1.07 (0.64 to 1.81) |
| Duration of critical care unit stay, mean (SD), d | 4.7 (7.3) [n = 281] | 7.7 (19.9) [n = 242] | MD, −3.0 (−5.7 to −0.3) | MD, −3.5 (−5.6 to −1.4) | |
| Duration of acute hospital stay, mean (SD), d | 13.7 (26.9) [n = 272] | 20.8 (50.3) [n = 231] | MD, −7.1 (−14.5 to 0.3) | MD, −8.8 (−14.8 to −2.8) | |
| COMFORT Behavior Scale score, mean (SD)c | |||||
| While receiving randomized treatment | 14.1 (3.6) [n = 193] | 14.5 (4.7) [n = 139] | MD, −0.4 (−1.3 to 0.5) | MD, −0.6 (−1.4 to 0.2) | |
| While receiving HFNC or CPAP | 13.9 (3.5) [n = 197] | 13.6 (3.6) [n = 157] | MD, 0.3 (−0.5 to 1.0) | MD, 0.2 (−0.4 to 0.9) | |
| Use of sedation during noninvasive respiratory support, No./total (%) | 80/286 (28.0) | 93/237 (39.2) | AD, −11.3 (−19.4 to −3.2) | OR, 0.60 (0.42-0.87) | OR, 0.54 (0.35 to 0.81) |
| Parental stress score at time of consent, mean (SD)d | 1.5 (0.8) [n = 174] | 1.6 (0.7) [n = 167] | MD, 0.0 (−0.2 to 0.1) | MD, 0.0 (−0.2 to 0.1) | |
Abbreviations: AD, absolute difference; CPAP, continuous positive airway pressure; HFNC, high-flow nasal cannula; HR, hazard ratio; MD, mean difference; OR, odds ratio.
Unadjusted effect estimate is not separately reported for some rows because it is the mean difference as reported in the “Difference” column.
Adjusted for prebaseline factors of age (<12 months vs ≥12 months), Spo2:Fio2 ratio, comorbidities (none vs neurological/neuromuscular vs other), reason for admission (bronchiolitis vs other respiratory vs cardiac vs other reason), respiratory support at randomization (yes vs no), severity of respiratory distress (severe vs mild or moderate), and site (using shared frailty).
COMFORT Behavior Scale scores were recorded every 6 hours until liberation from respiratory support and were aggregated to patient level using the median of all recorded scores.
Parental Stressor Scale: Pediatric Intensive Care Unit scores range from 1 (not stressful) to 5 (extremely stressful). A mean value of 1.6 indicates a low level of parental stress at the time of completing the questionnaire.