Introduction
Methods
ENOS Trial
Route of Feeding and Definitions
Statistics
Results
Feeding Route
All | Non-oral | Oral | Difference (95% CI) | 2p
| |
---|---|---|---|---|---|
Number of participants | 4011 | 1331 | 2680 | ||
Age (years) | 70.3 (12.2) | 73.9 (11.6) | 68.5 (12.1) | 5.4 (4.6, 6.2) | <0.001 |
Sex, male (%) | 2297 (57.3) | 701 (52.7) | 1596 (59.6) | −6.9 (−10.1, −3.6) | <0.001 |
Medical history (%) | |||||
Previous stroke | 594 (14.8) | 192 (14.4) | 402 (15.0) | −0.6 (−2.9, 1.7) | 0.63 |
Hypertension | 2607 (65.0) | 900 (67.6) | 1707 (63.7) | 3.9 (0.8, 7.0) | 0.014 |
Ischaemic heart disease | 669 (16.7) | 228 (17.1) | 441 (16.5) | 0.8 (−1.8, 3.3) | 0.55 |
Scandinavian Stroke Scale | 33.7 (13.2) | 24.6 (12.4) | 38.3 (11.0) | −13.7 (−14.5, −12.9) | <0.001 |
Blood pressure (mmHg) | |||||
Systolic | 167.2 (19.0) | 168.8 (19.4) | 166.5 (18.7) | 2.4 (1.1, 3.7) | <0.001 |
Diastolic | 89.5 (13.1) | 89.0 (13.3) | 89.8 (13.0) | −0.8 (−1.7, 0.1) | 0.069 |
Heart rate (bpm) | 77.5 (14.7) | 78.7 (15.8) | 76.9 (14.1) | 1.8 (0.8, 2.8) | <0.001 |
Stroke type (%) | |||||
Ischaemic | 3342 (83.3) | 1086 (81.6) | 2256 (84.2) | −2.6 (−5.1, −0.1) | 0.039 |
Haemorrhagic | 629 (15.7) | 234 (17.6) | 395 (14.7) | 2.8 (0.4, 5.3) | 0.020 |
Time to randomisation (hours) | 26.0 (12.9) | 25.4 (12.9) | 26.3 (12.8) | −0.8 (−1.7, 0.0) | 0.052 |
Syndrome (%) [23] | |||||
Total anterior | 1209 (30.1) | 724 (54.4) | 485 (18.1) | 36.3 (33.3, 39.3) | <0.001 |
Partial anterior | 1251 (31.2) | 378 (28.4) | 873 (32.6) | −4.2 (−7.2, −1.2) | 0.007 |
Posterior | 154 (3.8) | 25 (1.9) | 129 (4.8) | −2.9 (−4.0, −1.8) | <0.001 |
Lacunar | 1397 (34.8) | 204 (15.3) | 1193 (44.5) | −29.2 (−31.9, −26.5) | <0.001 |
Symptoms (%) | |||||
Dysphasia | 1610 (40.1) | 813 (61.1) | 797 (29.7) | 31.3 (28.2, 34.5) | <0.001 |
Neglect | 1068 (29.9) | 601 (55.1) | 467 (18.8) | 36.3 (33.0, 39.6) | <0.001 |
Side of lesion (%) | |||||
Right | 2091 (52.1) | 645 (48.5) | 1446 (54.0) | −5.5 (−8.8, −2.2) | 0.001 |
Left | 1903 (47.4) | 678 (50.9) | 1225 (45.7) | 5.2 (1.9, 8.5) | 0.002 |
Both | 17 (0.4) | 8 (0.6) | 9 (0.3) | 0.3 (−0.2, 0.7) | 0.22 |
Feeding route (%) | |||||
Normal diet | 1738 (43.3) | – | 1738 (64.9) | – | – |
Soft diet | 942 (23.5) | – | 942 (35.1) | – | – |
NGT-fed | 225 (5.6) | 225 (16.9) | – | – | – |
PEG-fed | 7 (0.2) | 7 (0.5) | – | – | – |
Intravenous/subcutaneous fluids | 726 (18.1) | 726 (54.5) | – | – | – |
No feeding fluids | 373 (9.3) | 373 (28.0) | – | – | – |
Neuroimaging (%) | |||||
Abnormal scan | 3763 (97.6) | 1274 (98.9) | 2489 (96.9) | 2.0 (1.1, 2.9) | <0.001 |
Location | |||||
Lobar (ACA, MCA, or PCA) | 1992 (51.6) | 834 (64.8) | 1158 (45.1) | 19.7 (16.4, 22.9) | <0.001 |
Lacunar | 396 (10.3) | 71 (5.5) | 325 (12.7) | −7.1 (−8.9, −5.3) | <0.001 |
Brainstem or cerebellar | 73 (1.9) | 20 (1.6) | 53 (2.1) | −0.5 (−1.4, 0.4) | 0.27 |
Mass effect, moderate to extreme | 1178 (31.3) | 542 (43.0) | 636 (25.4) | 17.6 (14.4, 20.8) | <0.001 |
Previous stroke lesion(s) | 2326 (60.5) | 763 (59.3) | 1563 (61.1) | −1.8 (−5.1, 1.5) | 0.28 |
Cerebral atrophy | 3229 (84.0) | 1086 (84.4) | 2143 (83.8) | 0.6 (−1.8, 3.1) | 0.63 |
Leukoaraiosis | 1644 (42.8) | 566 (44.0) | 1078 (42.1) | 1.8 (−1.5, 5.2) | 0.28 |
Feeding Route and Outcome
Number | All | No oral feeding | Oral feeding | OR/MD unadjusted | 2p
| OR/MD adjusted | 2p
| |
---|---|---|---|---|---|---|---|---|
Participants | 1331 | 2680 | ||||||
Day 7 | ||||||||
Death (%) | 4001 | 119 (3.0) | 86 (6.5) | 33 (1.2) | 5.54 (3.69, 8.32) | <0.001 | 1.64 (1.02, 2.62) | 0.040 |
Death or deterioration (%) | 3991 | 378 (9.5) | 229 (17.3) | 149 (5.6) | 3.52 (2.83, 4.38) | <0.001 | 1.92 (1.48, 2.48) | <0.001 |
SSS | 3991 | 38.8 (16.1) | 29.0 (17.4) | 43.7 (12.9) | −14.7 (−15.6, −13.7) | <0.001 | −1.3 (−2.0, −0.5) | <0.001 |
Hospital | ||||||||
Length of stay (days) | 3985 | 20.9 (23.6) | 30.2 (28.9) | 16.3 (18.8) | 13.9 (12.4, 15.4) | <0.001 | 6.8 (5.2, 8.5) | <0.001 |
RTI, all (%)a
| 4011 | 257 (6.4) | 183 (13.7) | 74 (2.8) | 5.61 (4.25, 7.42) | <0.001 | 2.03 (1.46, 2.82) | <0.001 |
RTI, fatal (%)a
| 4011 | 149 (3.7) | 115 (8.6) | 34 (1.3) | 7.36 (4.99, 10.86) | <0.001 | 2.32 (1.48, 3.64) | <0.001 |
Admitted to SRU (%) | 3984 | 2018 (50.7) | 817 (61.8) | 1201 (45.1) | 1.97 (1.72, 2.26) | <0.001 | 2.03 (1.73, 2.38) | <0.001 |
SLT management (%) | 3984 | 1979 (49.7) | 951 (72.0) | 1028 (38.6) | 4.09 (3.54, 4.72) | <0.001 | 3.51 (2.98, 4.15) | <0.001 |
To institution (%) | 3666 | 1157 (31.6) | 577 (53.0) | 580 (22.5) | 3.89 (3.35, 4.52) | <0.001 | 2.37 (1.99, 2.81) | <0.001 |
Died (%) | 4011 | 320 (8.0) | 233 (17.5) | 87 (3.2) | 6.32 (4.90, 8.17) | <0.001 | 1.98 (1.47, 2.67) | <0.001 |
Day 90 | ||||||||
Death (%) | 3996 | 496 (12.4) | 314 (23.6) | 182 (6.8) | 4.23 (3.47, 5.15) | <0.001 | 1.35 (1.06, 1.71) | 0.014 |
mRS (/6) | 3995 | 3.1 (1.7) | 4.0 (1.7) | 2.7 (1.6) | 1.3 (1.2, 1.4) | <0.001 | 0.2 (0.1, 0.3) | <0.001 |
Barthel Index (/100) | 3970 | 64.4 (38.8) | 43.1 (40.8) | 75.0 (32.9) | −32.0 (−34.3, −29.6) | <0.001 | −7.3 (−9.5, −5.0) | <0.001 |
tMMSE (/19) | 2032 | 11.0 (7.6) | 6.8 (8.2) | 13.0 (6.4) | −6.2 (−6.8, −5.5) | <0.001 | −1.0 (−1.6, −0.3) | 0.003 |
TICS (/37) | 2013 | 14.7 (10.7) | 9.1 (11.0) | 17.4 (9.3) | −8.4 (−9.3, −7.4) | <0.001 | −1.2 (−2.1, −0.3) | 0.012 |
Animal naming | 2366 | 9.3 (7.8) | 5.9 (7.5) | 10.9 (7.4) | −5.0 (−5.7, −4.4) | <0.001 | −0.6 (−1.3, 0.0) | 0.068 |
ZDS | 3253 | 58.5 (24.1) | 69.5 (26.5) | 54.0 (21.5) | 15.5 (13.8, 17.3) | <0.001 | 4.1 (2.3, 5.9) | <0.001 |
EQ-5D HUS (/1.0) | 3952 | 0.5 (0.4) | 0.3 (0.4) | 0.5 (0.4) | −0.3 (−0.3, −0.2) | <0.001 | −0.03 (−0.1, 0.0) | 0.028 |
EQ-VAS | 3440 | 56.1 (31.2) | 42.5 (34.4) | 62.0 (27.7) | −19.5 (−21.6, −17.3) | <0.001 | −3.3 (−5.5, −1.1) | 0.004 |
Not at homeb
| 3980 | 1326 (33.3) | 751 (56.6) | 575 (21.7) | 4.72 (4.09, 5.45) | <0.001 | 2.19 (1.85, 2.59) | <0.001 |
Feeding Route and Respiratory Tract Infection
Glyceryl Trinitrate and Feeding Route
Number | All | GTN | No GTN | OR | 2p
| |
---|---|---|---|---|---|---|
Participants | 273 | 144 | 129 | |||
Day 7 | ||||||
Feeding route [/7]a
| 270 | 1 [1, 2] | 1 [1, 2] | 1 [1, 2] | 0.61 (0.38, 0.98) | 0.040 |
Feeding, non-oral | 264 | 42 (15.9) | 18 (12.6) | 24 (19.8) | 0.58 (0.30, 1.13) | 0.11 |
Hospital | ||||||
RTI, allb
| 273 | 12 (4.4) | 3 (2.1) | 9 (7.0) | 0.28 (0.08, 1.07) | 0.063 |
RTI, fatal | 273 | 8 (2.9) | 1 (0.7) | 7 (5.4) | 0.12 (0.01, 1.00) | 0.05 |
Admitted to SRU | 268 | 101 (37.7) | 52 (36.4) | 49 (39.2) | 0.89 (0.54, 1.45) | 0.63 |
Discharge to institution | 243 | 73 (30.0) | 40 (29.6) | 33 (30.6) | 0.96 (0.55, 1.66) | 0.88 |
Died | 273 | 25 (9.2) | 8 (5.6) | 17 (13.2) | 0.39 (0.16, 0.93) | 0.034 |
Day 90 | ||||||
Feeding: unable/need helpc
| 236 | 74 (31.4) | 36 (27.1) | 38 (36.9) | 0.63 (0.36, 1.10) | 0.11 |