Table 2. Primary and Secondary Outcome Results.
| Tracheostomy, No./total (%) | Absolute difference, % (95% CI) | Effect measure (95% CI) | ||
|---|---|---|---|---|
| Early (n =186) | Standard (n = 194) | |||
| Primary outcome, 6 mo | ||||
| Modified Rankin Scale score, 0-4a | 77/177 (43.5) | 89/189 (47.1) | −3.6 (−14.3 to 7.2) | aOR, 0.93 (0.60 to 1.42)b,c,d |
| Secondary outcomes | ||||
| Modified Rankin Scale score, 0-3 at 6 moa | 43/177 (24.3) | 37/189 (19.6) | 4.7 (−4.3 to 13.7) | aOR, 1.48 (0.89 to 2.48)b,c |
| Death | ||||
| at 6 mo | 62/177 (35.0) | 56/189 (29.6) | 5.4 (−4.7 to 15.5) | aHR, 1.06 (0.74 to 1.53)b,e |
| in ICUf | 26/186 (14.0) | 29/194 (14.9) | −1.0 (−8.6 to 6.6) | |
| Due to withdrawal of life-sustaining therapy | 24/186 (12.9) | 21/194 (10.8) | 2.1 (−5.0 to 9.1) | |
| Time to discharge, dg | ||||
| ICU, median (IQR) | 17 (12 to 26) | 19 (14 to 26) | HR, 1.12 (0.90 to 1.39) | |
| Hospital | 24 (15 to 41) | 26 (17 to 44) | HR, 1.06 (0.85 to 1.32) | |
| Discharge destination | ||||
| Home | 1/144 (0.7) | 5/156 (3.2) | ||
| Rehabilitation center | 101/144 (70.1) | 110/156 (70.5) | ||
| Long-term care facility | 26/144 (18.1) | 25/156 (16.0) | ||
| Otherh | 16/144 (11.1) | 16/156 (10.3) | ||
| Location of survivors at 6 mo | ||||
| Home | 54/115 (47.0) | 65/133 (48.9) | ||
| Hospital | 6/115 (5.2) | 2/133 (1.5) | ||
| Rehabilitation center | 29/115 (25.2) | 29/133 (21.8) | ||
| Long-term care facility | 23/115 (20.0) | 36/133 (27.1) | ||
| Otheri | 3/115 (2.6) | 1/133 (0.8) | ||
| Respirator weaning started | 138/186 (74.2) | 130/194 (67.0) | 7.2 (−2.5 to 16.8) | |
| Time to start weaning, dj | 6 (4 to 11) | 6 (3 to 13) | HR, 1.24 (0.98 to 1.58) | |
| Successful weaningk | 87/186 (46.8) | 91/194 (46.9) | −0.1 (−10.7 to 10.4) | |
| Time to end mechanical ventilation, median (IQR), dj | 14 (8 to 20) | 11 (8 to 18) | HR, 0.97 (0.73 to 1.31) | |
| Extubation attempts | ||||
| At least 1 | 18/186 (9.7) | 75/194 (38.7) | ||
| More than 1 | 4/186 (2.2) | 21/194 (10.8) | ||
| First attempt successfull | 2/18 (11.1) | 35/75 (46.7) | ||
| Extubated after weaningl | 3/18 (16.7) | 43/75 (57.3) | ||
| Recovery of consciousnessm | 100/141 (70.9) | 97/144 (67.4) | 3.6 (−7.9 to 15.0) | |
| Time to first day out of coma, median (IQR), dj | 4 (1.5 to 7.5) | 5 (2 to 10) | HR, 1.15 (0.87 to 1.52) | |
| ICU stay, median (IQR), dm | ||||
| Without sedatives | 9 (5 to 14) | 9 (3 to 15) | HL, 0 (−1 to 2) | |
| Without opioids | 8 (1 to 14) | 8 (1 to 14) | HL, 0 (−2 to 1) | |
| Without vasopressors | 11 (6 to 16) | 12 (4.5 to 17) | HL, 0 (−1 to 2) | |
| Fraction of total days in ICU, median (IQR)m | ||||
| Without sedatives | 0.6 (0.3 to 0.8) | 0.5 (0.2 to 0.8) | HL, 0.02 (−0.04 to 0.1) | |
| Without opioids | 0.5 (0.1 to 0.8) | 0.5 (0.1 to 0.8) | HL, 0 (−0.08 to 0.04) | |
| Without vasopressors | 0.8 (0.4 to 1) | 0.8 (0.3 to 1) | HL, 0 (0 to 0.07) | |
Abbreviations: aHR, adjusted hazard ratio; aOR, adjusted odds ratio; GCS, Glasgow Coma Scale; HL, Hodges-Lehmann estimate; ICU, intensive care unit; mRS, modified Rankin Scale.
See Table 1 footnotes for score definitions.
Adjusted for age, baseline GCS, and country.
Used multiple imputation to replace missing values.
P = .73 for the primary end point. See eTable 2 in Supplement 3 for other variables.
Patients lost to follow-up were censored: 1 patient was excluded from this Cox regression due to missing GCS status at baseline.
Therapy withdrawals during ICU were counted as ICU deaths.
Median (IQR) by Kaplan-Meier method. Patients who died during ICU or hospital stay were censored after the last patient was discharged.
Other destinations: acute care hospital, palliative care facility, hospice, skilled nursing, and step-down unit.
Other locations: monastery, assisted living, skilled nursing, and nursing home.
Median (IQR) for patients who reached the end point. HR from a Cox proportional hazards model for which deaths before reaching the end point were censored after the last event in the cohort.
End of mechanical ventilation the same day as death or treatment withdrawal were not counted; 94 more decannulations noted in the follow-up (early tracheostomy, 41; standard tracheostomy, 54).
Nonterminal extubations not leading to reintubation or tracheotomy are counted as successful.
Fewer patients because variables were added after a protocol amendment (early group, 141; standard group, 144).