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Early tracheotomy ineffective at preventing ventilator-associated pneumonia in mechanically ventilated ICU patients

Clinical Question:
Does early tracheotomy improve outcomes in mechanically ventilated patients in the intensive care unit?

Bottom Line:
Although underpowered to detect a difference, this study suggests that early tracheotomy does not decrease the incidence of ventilator-associated pneumonia (VAP) for intensive care unit (ICU) patients. Furthermore, although patients may have more ventilator-free days and ICU-free days, there is no mortality benefit or reduction in overall hospital length of stay with early tracheotomy. (LOE = 1b)

Reference:
Terragni PP, Antonelli M, Fumagalli R, et al. Early versus late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients. JAMA 2010;303:1483-1489.  [PMID:20407057]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Government

Allocation:
Concealed

Setting:
Inpatient (ICU only)

Synopsis:
These investigators enrolled 600 ICU patients who had acute respiratory failure requiring mechanical ventilation for at least 24 hours without evidence of pulmonary infection. At 48 hours after enrollment, those with unchanged or worsening respiratory status and those without resolution of the acute clinical condition requiring mechanical ventilation were randomized -- using concealed allocation -- to receive either early tracheotomy at 6 to 8 days after intubation (n = 209) or late tracheotomy at 13 to 15 days after intubation (n = 210). Tracheotomy was not performed if the patient?s respiratory condition improved or the acute clinical condition requiring mechanical ventilation resolved during the allotted period. Patients in both groups had similar baseline characteristics at randomization, including age and sequential organ failure assessment score. Overall, 69% of patients in the early group underwent tracheotomy at a mean of 7 days after intubation as compared with 57% of patients in the late group at a mean of 14 days after intubation. Clinicians masked to patient allocation assessed the primary outcome of cumulative incidence of VAP at 28 days using the Clinical Pulmonary Infection Score. Analysis was by intention to treat. No significant difference was detected in the incidence of VAP at 28 days between the 2 groups. Given a lower than predicted rate of VAP in the late group, the study was underpowered to detect at least a 35% risk reduction in the primary outcome. However, even if a reduction in VAP truly exists, the clinical benefits of early tracheotomy are not overwhelming. Although patients in the early group had more ventilator-free days and ICU-free days, there was no reduction in overall hospital length of stay and no mortality benefit at 28 days or 1 year. In addition, almost 40% of patients who underwent tracheotomies in the study experienced adverse events, including stoma infection and bleeding.

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