Table 3. Secondary Outcomes, Complications, and Adverse Events.
| Secondary outcomes | No. (%)a | Estimate of difference (95% CI), %a |
Unadjusted OR (95% CI)a | Adjusted OR (95% CI)a,b | |
|---|---|---|---|---|---|
| High-flow oxygen (n = 753) | Standard oxygen (n = 764) | ||||
| Total length of hospital stay since presentation to the emergency department, median (IQR), d | 1.93 (1.21 to 2.94) | 1.72 (1.03 to 2.68) | 0.22 (0.09 to 0.35) | HR, 0.85 (0.77 to 0.94) | HR, 0.82 (0.74 to 0.91) |
| Length of oxygen therapy after randomization, median (IQR), d | 1.07 (0.50 to 2.06) | 0.75 (0.35 to 1.61) | 0.33 (0.20 to 0.46) | HR, 0.79 (0.71 to 0.87) | HR, 0.78 (0.70 to 0.86) |
| Escalation of care to an ICU | 94 (12.5) | 53 (6.9) | 5.5 (2.6 to 8.5) | 1.91 (1.34 to 2.72) | 1.93 (1.35 to 2.75) |
| Required noninvasive ventilation | 7 (7.4) | 6 (11.3) | |||
| Required invasive ventilation | 4 (4.3) | 0 | |||
| Required transfer to a tertiary hospital with onsite PICU, No./total (%)c | 2/85 (2.3) | 2/90 (2.2) | 0.1 (−4.3 to 4.5) | 1.05 (0.14 to 7.61) | 0.92 (0.13 to 6.75) |
| Change of allocated therapy and reason for the change d | |||||
| Change in oxygen therapy in general ward or emergency department | 323 (42.9) | 141 (18.5) | 24.4 (20.0 to 28.9) | 3.32 (2.63 to 4.19) | 3.42 (2.70 to 4.34) |
| Trigger of early-warning tool | 117 (15.5) | 111 (14.5) | 1.0 (−2.6 to 4.6) | 1.08 (0.82 to 1.43) | 1.09 (0.82 to 0.24) |
| Increased work of breathing | 33 (4.4) | 98 (12.8) | −8.4 (−11.2 to −5.6) | 0.31 (0.21 to 0.47) | 0.30 (0.20 to 0.46) |
| Decreased level of consciousness | 2 (0.3) | 2 (0.3) | 0 (−0.5 to 0.5) | 1.01 (0.14 to 7.22) | 1.01 (0.14 to 7.21) |
| Deterioration of cardiovascular function with impaired peripheral perfusion | 0 | 2 (0.3) | |||
| Clinician-directed treatment switch | 136 (18.1) | 123 (16.1) | 2.0 (−1.8 to 5.7) | 1.15 (0.88 to 1.50) | 1.15 (0.88 to 1.51) |
| Based on review by ICU team | 12 (1.6) | 27 (3.5) | −1.9 (−3.5 to 0.4) | 0.44 (0.22 to 0.88) | 0.43 (0.21 to 0.86) |
| Intolerance of allocated oxygen therapy | 92 (12.2) | 0 | |||
| Complications and adverse events | |||||
| Death | 1 (0.1) | 0 | |||
| Air leak syndrome, emergency intubation, cardiac arrest, or respiratory arrest | 0 | 0 | |||
| Nosebleed | 2 (0.3) | 0 | |||
Abbreviations: HR, hazard ratio; ICU, intensive care unit; OR, odds ratio; PICU, pediatric intensive care unit.
a
Unless otherwise indicated.
b
Adjusted for presence or absence of obstructive airway disease at randomization and study site.
c
Only includes those who were admitted to hospitals without onsite PICUs.
d
Multiple clinical reasons may have been recorded.