Background
Methods
Lung recruitment maneuver
Sample size calculation
Statistical analysis
Results
Study participants
Characteristics | Intervention (n = 15) | Control (n = 15) |
P-value* | |
---|---|---|---|---|
GA at birth, mean (SD), [weeks + days] | 23 + 6 (0 + 5) | 24 + 4 (0 + 6) | 0.06 | |
Weight at birth, mean (SD), [g] | 650 (115) | 615 (95) | 0.38 | |
Antenatal steroids (complete administration), n (%) | 9 (60) | 8 (53) | 0.79 | |
Male, n (%) | 9 (60) | 10 (67) | 0.45 | |
Day of life at HFOV start, mean (SD), [d] | 3 (4) | 5 (6) | 0.23 | |
GA at HFOV start, mean (SD), [weeks + days] | 24 + 2 (0 + 6) | 25 + 1 (1 + 1) | 0.03 | |
Weight at HFOV start, mean (SD), [g] | 650 (115) | 615 (105) | 0.36 | |
OSI at HFOV start, mean (SD) | 4.09 (1.94) | 5.87 (3.64) | 0.11 | |
Main cause of respiratory failure | ||||
Severe respiratory distress syndrome, n (%) | 11 (73.3) | 7 (46.7) | 0.26 | |
Sepsis, n (%) | 1 (6.7) | 4 (26.7) | 0.33 | |
Pneumonia, n (%) | 0 (0) | 2 (13.3) | 0.48 | |
Necrotizing enterocolitis, n (%) | 2 (13.3) | 1 (6.7) | 1.0 | |
Severe pulmonary hypertension, n (%) | 1 (6.7) | 1 (6.7) | 1.0 |
Primary outcome
Secondary outcome
Lung recruitment maneuver
Results | Total (n = 30) | Intervention (n = 15) | Control (n = 15) | P* | |
---|---|---|---|---|---|
Primary outcome
| |||||
Cumulative OSI, mean (SD) | 5.13 (1.90) | 4.95 (1.72) | 5.30 (2.08) | 0.61 | |
Secondary outcome
| |||||
Average number of recruitments in 12 h, mean (SD) | 1.22 (0.40) | 1.33 (0.22) | 1.11 (0.51) | 0.13 | |
Average number of recruitments, median (min, max), n | 11 (1,21) | 13 (3, 21) | 8 (1, 21) | 0.25 | |
Duration of CMV in study period, median (min, max), h | 7.0 (0, 108) | 7.3 (0, 55) | 6.8 (0, 108) | 0.87 | |
Duration of HFOV in study period, median (min, max), h | 121 (30, 173) | 127 (30, 173) | 104 (34, 161) | 0.56 | |
Total duration of CMV, median (min, max), h | 82 (0, 850) | 160 (0, 551) | 73 (0, 850) | 0.27 | |
Total duration of HFOV, median (min, max), h | 129 (31, 445) | 131 (31, 445) | 107 (34, 254) | 0.43 | |
Averagea S/F ratio, mean (SD) | 256 (68) | 260 (68) | 251 (69) | 0.71 | |
Averagea SpO2, mean (SD) [%] | 91.4 (0.8) | 91.3 (0.9) | 91.5 (0.7) | 0.51 | |
Averagea FiO2, mean (SD) [%] | 0.43 (0.14) | 0.42 (0.13) | 0.43 (0.16) | 0.78 | |
Averagea MAP, mean (SD) [mbar] | 10.8 (1.2) | 10.5 (1.4) | 11.1 (1.0) | 0.18 | |
Maximum MAP in LRM, median (min, max), [mbar] | 19 (11, 25) | 19 (11, 25) | 18 (13, 24) | 0.35 | |
Survival, n (%) | 21 (70) | 10 (67) | 11 (73) | 1.0 | |
BPD (I-III)b, n (%) | 18 (60) | 10 (67) | 8 (53) | 0.71 | |
BPD (I-III)b in survivors, n (%) | 21 (76) | 9 (90) | 7 (64) | 0.31 | |
BPD (II-III)b in survivors, n (%) | 5 (24) | 4 (40) | 1 (9) | 0.14 | |
Pneumothorax, n (%) | 5 (17) | 3 (20) | 2 (13) | 1.0 | |
Severe intraventricular hemorrhage, n (%) | 7 (23) | 5 (33) | 2 (13) | 0.39 | |
Pulmonary interstitial emphysema, n (%) | 4 (13) | 2 (13) | 2 (13) | 1.0 |
Indication | N (%) | D [min]b | MAPmax | MAP start | MAP end | FiO2 start | FiO2 end |
---|---|---|---|---|---|---|---|
Start HFOV | 35 (9) | 75 (40) | 18 (3) | 11.2 (1.8) | 10.5 (2.2) | 50 (26) | 38 (18)* |
Surfactant application | 19 (5) | 68 (40) | 19 (3) | 11.2 (1.6) | 11.4 (1.4) | 55 (22) | 41 (16)* |
Change of position | 102 (26) | 80 (47) | 20 (3) | 11.0 (1.4) | 10.9 (1.5) | 61 (26) | 48 (23)* |
Decrease of SpO2a | 84 (22) | 63 (44) | 19 (4) | 11.0 (1.8) | 10.5 (1.9) | 56 (25) | 48 (22)* |
Atelectasis | 27 (7) | 57 (42) | 18 (2) | 10.8 (1.2) | 10.7 (1.4) | 57 (24) | 47 (18)* |
Per protocol | 71 (18) | 72 (40) | 18 (3) | 10.9 (1.8) | 10.4 (1.8) | 44 (17) | 36 (14)* |
All | 388 | 70 (43) | 19 (3) | 11.0 (1.6) | 10.8 (1.6) | 56 (24) | 45 (20)* |