TracMan (Tracheostomy Management in critical Care)

Started   January 2005

Completion December 2008

In patients predicted to require ventilatory support for 7 days or more, placing a tracheostomy on day 1 to 4 following ICU admission reduces mortality at day 30 (post randomisation) compared with a tracheostomy placed on or after day 10.

Principal Investigator
Dr Duncan Young University of Oxford Radcliffe

Study Hypothesis
There is inadequate evidence from large-scale randomised controlled trials to determine reliably the optimum time to perform a tracheostomy in ventilator-dependent patients. A detailed literature search located only two methodologically sound RCTs in this area, though both were small and single centre. One study showed a mortality benefit from early placement of a tracheostomy in patients on a medical ICU. The other showed no benefit in patients with cutaneous burns.

In spite of the lack of good evidence supporting either the use of tracheostomy or informing the correct time to perform one, large numbers of these procedures are carried out in the UK each year. The critical care community in the UK recently identified the timing of tracheostomy as an area of clinical equipoise, where good quality information from clinical trials was needed to inform practice. An expert panel viewed such a trial as both important and feasible.

Tracheostomy management is also currently a topic of considerable interest internationally.

Participants
1692 patients (846 in each arm).
87 Adult ICUs in the United Kingdom able to care for Level 3 patients.