Background
Methods
Design and patients
Ethics
Outcomes
Statistical analysis
Results
Population
Mortality according to lung morphology
Variables | Both groups* n = 360 | Focal ARDS n = 124 | Non-focal ARDS n = 236 | P value‡ |
---|---|---|---|---|
Baseline patient data | ||||
Age, years, mean [SD] | 61 [15] | 61 [15] | 62 [15] | 0.301 |
Males, n (%) | 266 (74%) | 101 (81%) | 165 (70%) | 0.018 |
Female, n (%) | 94 (26%) | 23 (19%) | 71 (30%) | 0.018 |
COPD, n (%) | 32 (9%) | 16 (13%) | 16 (7%) | 0.052 |
Chronic renal failure, n (%) | 6 (2%) | 1 (1%) | 5 (2%) | 0.355 |
Non-haematological cancers, n (%) | 41 (11%) | 13 (10%) | 28 (12%) | 0.695 |
Haematological cancers, n (%) | 14 (4%) | 3 (2%) | 11 (5%) | 0.296 |
Diabetes, n (%) | 41 (11%) | 14 (11%) | 27 (11%) | 0.966 |
Arterial hypertension, n (%) | 75 (21%) | 26 (21%) | 49 (21%) | 0.964 |
Smoking, n (%) | 10 (3%) | 3 (2%) | 7 (3%) | 0.764 |
Alcohol disturbance, n (%) | 46 (13%) | 13 (10%) | 33 (14%) | 0.345 |
Vasculopathy, n (%) | 66 (18%) | 23 (19%) | 43 (18%) | 0.939 |
Cardiopathy, n (%) | 31 (9%) | 12 (10%) | 19 (8%) | 0.601 |
BMI, kg/m2, mean [SD] | 26.3 [5.1] | 27.1 [5.0] | 25.9 [5.1] | 0.030 |
McCabe score | 0.924 | |||
0, n (%) | 249 (69%) | 85 (69%) | 164 (69%) | |
1, n (%) | 98 (27%) | 35 (28%) | 63 (27%) | |
2, n (%) | 13 (4%) | 4 (3%) | 9 (4%) | |
Baseline intensive care data | ||||
Medical condition at admission, n (%) | 300 (83%) | 99 (80%) | 201 (85%) | 0.197 |
SAPS II, mean [SD] | 51 [16] | 52 [16] | 51 [16] | 0.629 |
SOFA, mean [SD] | 9 [4] | 10 [4] | 9 [4] | 0.182 |
PaO2/FiO2, mean [SD] | 117 [42] | 115 [40] | 118 [43] | 0.704 |
Plateau pressure, cm H2O, mean [SD]† | 24 [6] | 23 [4] | 24 [6] | 0.029 |
PEEP, cm H2O, mean [SD]† | 10 [3] | 9 [3] | 10 [4] | 0.047 |
Driving pressure, cm H2O, mean [SD]† | 14 [5] | 13 [4] | 14 [5] | 0.038 |
Tidal volume over ideal body weight, mL/kg, mean [SD]† | 6.6 [1.1] | 6.6 [1.1] | 6.5 [1.1] | 0.218 |
FiO2, %, mean [SD]† | 77 [20] | 75 [20] | 77 [21] | 0.361 |
Steroids, n (%) | 80 (22%) | 22 (18%) | 58 (25%) | 0.177 |
Shock at baseline, n (%) | 222 (62%) | 81 (65%) | 141 (60%) | 0.301 |
Renal replacement therapy, n (%) | 91 (25%) | 34 (27%) | 57 (24%) | 0.582 |
Primary lung injury | 0.341 | |||
Pneumonia, n (%) | 174 (48%) | 52 (42%) | 122 (52%) | |
Non-pulmonary infection, n (%) | 73 (20%) | 28 (23%) | 45 (19%) | |
Aspiration, n (%) | 79 (22%) | 31 (25%) | 48 (20%) | |
Trauma, n (%) | 7 (2%) | 4 (3%) | 3 (1%) | |
Other, n (%) | 27 (8%) | 9 (7%) | 18 (8%) | |
Outcomes | ||||
Ventilator-free days to day 28, days, mean [SD] | 13 [10] | 15 [9] | 13 [10] | 0.151 |
ICU LOS, days, mean [SD] | 17 [16] | 17 [14] | 17 [17] | 0.917 |
Predictors | Early mortality | Late mortality | ||
---|---|---|---|---|
Hazard ratio* | p value | Hazard ratio* | p value | |
Non-focal ARDS | 4.40 [1.93–10.01] | < 0.001 | 2.79 [0.81–9.63] | 0.106 |
Age | 1.04 [1.02–1.07] | < 0.001 | 1.03 [0.99–1.07] | 0.126 |
Males | 0.85 [0.45–1.60] | 0.618 | 0.82 [0.25–2.74] | 0.751 |
Haematological cancers | 2.27 [0.95–5.43] | 0.064 | 1.73 [0.17–17.70] | 0.642 |
Non-haematological cancers | 2.09 [0.95–4.57] | 0.066 | 1.48 [0.39–5.68] | 0.566 |
COPD | 1.33 [0.55–3.25] | 0.525 | 2.30 [0.54–9.84] | 0.263 |
McCabe | 1.11 [0.71–1.73] | 0.645 | 3.56 [1.45–8.72] | 0.005 |
BMI | 0.99 [0.94–1.05] | 0.789 | 0.93 [0.84–1.04] | 0.213 |
SAPS II (without age)† | 1.02 [1.00–1.04] | 0.047 | 1.02 [0.98–1.07] | 0.357 |
PaO2/FiO2 | 1.00 [1.00–1.01] | 0.586 | 0.99 [0.98–1.00] | 0.065 |
Plateau pressure | 1.12 [0.91–1.37] | 0.285 | 0.86 [0.59–1.25] | 0.426 |
PEEP | 0.90 [0.74–1.10] | 0.305 | 1.07 [0.72–1.58] | 0.740 |
Driving pressure | 0.91 [0.74–1.11] | 0.360 | 1.16 [0.80–1.68] | 0.426 |
Shock | 1.24 [0.67–2.27] | 0.493 | 1.55 [0.48–5.06] | 0.466 |
Mechanical ventilation over 48 h | 2.08 [0.61–7.09] | 0.243 | 0.71 [0.15–3.28] | 0.659 |
Steroid | 1.13 [0.63–2.03] | 0.689 | 1.66 [0.54–5.12] | 0.381 |
Renal replacement therapy | 2.42 [1.40–4.20] | 0.002 | 0.29 [0.06–1.46] | 0.133 |
Intervention arm in LIVE study$ | 0.65 [0.38–1.11] | 0.115 | 1.66 [0.56–4.96] | 0.362 |
Quality of life according to lung morphology
Variables | Both groups* n = 147 | Focal ARDS n = 60 | Non-focal ARDS n = 87 | p values‡ |
---|---|---|---|---|
Health-related quality of life: SF-36 (normalised score) | ||||
Physical functioning, median [IQR] | 37 [21–47] | 37 [21–47] | 34 [21–48] | 0.80 |
Physical component summary, median [IQR] | 37 [31–46] | 39 [34–45] | 36 [30–47] | 0.47 |
Mental health, median [IQR] | 44 [38–52] | 44 [35–52] | 44 [38–51] | 0.38 |
Mental component summary, median [IQR] | 41 [34–49] | 39 [32–48] | 41 [36–51] | 0.20 |
Mental health symptoms: HAD | ||||
Anxiety subscale, median [IQR] | 6 [3–10] | 7 [4–10] | 6 [3–9] | 0.09 |
Patients with anxiety, n (%) | 60 (41%) | 27 (45%) | 33 (38%) | 0.44 |
Depression subscale, median [IQR] | 6 [3–9] | 6 [4–9] | 6 [3–9] | 0.23 |
Patients with depression, n (%) | 51 (35%) | 22 (37%) | 29 (33%) | 0.75 |
Effect of fatigue on quality of life: MFIS | ||||
Physical functioning, median [IQR] | 25 [18–30] | 24 [15–29] | 25 [18–30] | 0.42 |
Cognitive functioning, median [IQR] | 18 [10–25] | 18 [10–26] | 17 [10–25] | 0.51 |
Psychosocial functioning, median [IQR] | 5 [2–6] | 5 [2–7] | 5 [2–6] | 0.68 |
MFIS component summary, median [IQR] | 48 [33–59] | 46 [35–61] | 48 [32–58] | 0.97 |
Patients with fatigue, n (%) | 91 (62%) | 34 (57%) | 57 (66%) | 0.43 |