Tracheostomy in ventilator dependent trauma patients: a prospective, randomized intention-to-treat study.

BACKGROUND: Tracheostomy is a commonly performed procedure in ventilator dependent patients. Many critical care practitioners believe that performing a tracheostomy early in the postinjury period decreases the length of ventilator dependence as well as having other benefits such as better patient tolerance and lower respiratory dead space. We conducted a randomized, prospective, single institution study comparing the length ventilator dependence in critically ill multiple trauma patients who were randomized to two different strategies for performance of a tracheostomy. We hypothesized that earlier tracheostomy would reduce the number of days of mechanical ventilation, frequency of pneumonia and length of intensive care unit (ICU) stay.
METHODS: Patients were eligible if they were older than 15 years and either a Glasgow Coma Score (GCS) >4 with a negative brain computed tomography (CT) (no anatomic head injury), or a GCS >9 with a positive head CT (known anatomic head injury). Patients who required tracheostomy for facial/neck injuries were excluded. Patients were randomized to an intention to treat strategy of tracheostomy placement before day 8 or after day 28.
RESULTS: The study was halted after the first interim analysis. There were 60 enrolled patients, who had comparable demographics between groups. There was no significant difference between groups in any outcome variable including length of ventilator support, pneumonia rate, or death.
CONCLUSION: A strategy of tracheostomy before day 8 postinjury in this group of trauma patients did not reduce the number of days of mechanical ventilation, frequency of pneumonia or ICU length of stay as compared with the group with a tracheostomy strategy involving the procedure at 28 days postinjury or more.

RCT Entities:   Population Interventions Outcomes