ABSTRACT
Importance: Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation. Objective: To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation. Design, Setting, and Participants: In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020. Interventions: Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194). Main Outcomes and Measures: The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death). Results: Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, -3.6% [95% CI, -14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy. Conclusions and Relevance: Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded. Trial Registration: ClinicalTrials.gov Identifier: NCT02377167.
Subject(s)
Reflex, Abnormal , Respiration, Artificial , Respiratory Tract Diseases , Stroke , Tracheostomy , Airway Management , Female , Humans , Male , Middle Aged , Recovery of Function , Respiration, Artificial/adverse effects , Respiration, Artificial/methods , Respiratory Tract Diseases/etiology , Respiratory Tract Diseases/physiopathology , Respiratory Tract Diseases/therapy , Stroke/complications , Stroke/physiopathology , Stroke/therapy , Time Factors , Tracheostomy/adverse effects , Treatment Outcome , Ventilator Weaning/methodsABSTRACT
Patients with cSDH presenting with new or worsening neurological deficits, especially if they are debilitating and adversely affecting quality of life require urgent medical and surgical attention. Neurological and neurosurgical critical care team need to stabilize the patient by reversing any underlying coagulopathy states in order to prevent further hematoma expansion.In the event of brain herniation and presumed ICP elevation and CPP compromise, step-wise ICP management should be instituted promptly.Seizure prophylaxis treatment is reasonable. Timing of surgical evacuation is not always easy to determine but the presence of significant neurological deficits with impending herniation require immediate surgical Intervention. Consideration of the clot density along with patient's current neurological status would determine the timing and type of surgical interventions. Postoperative critical care management is not trivial. In addition to detecting any changes in neurological conditions, timely initiation (typically within the first 48 hours if clinical and radiographic conditions are stable with no co-existing coagulopathy) of venous thromboembolism prophylaxis is essential. Resuming antiplatelets and anticoagulants are warranted for those with clear indications including atrial fibrillation, atrial thrombus, known deep vein thrombosis, mechanical heart valves and other preexisting hypercoagulable conditions, but it is generally advised to hold antiplatelets and anticoagulants for about 10-14 post injury and/or surgical intervention.