TracMan

TracMan: Effect of Early vs Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation

Young et al. JAMA 2013; 309:2121-2129. doi:10.1001/jama.2013.5154

Clinical Question

  • In mechanically ventilated adult patients with a high risk of prolonged ventilation, does early tracheostomy compared with late tracheostomy reduce mortality at 30 days?

Design

  • Large, multi-centre, randomised, controlled trial
  • Pilot study and national survey to estimate baseline prevalence
  • Block randomisation with minimisation algorithm to prevent imbalance between health centre, age, sex and 7 diagnostic groups
  • Clinicians, patients and data analysts not blinded
  • Intention-to-treat analysis
  • Multiple power calculations due to changing baseline and ultimately recruitment fatigue
    • Final recruitment was powered to detect 8.3% absolute reduction in 30-day mortality from a baseline of 31.5%, with 80% power and 5% accepted significance level.

Setting

  • 70 adult, general Intensive Care Units across the UK
    • 13 university associated
    • 59 non-university associated
  • November 2004 to November 2008

Population

  • Inclusion: Any intubated and ventilated adult patient where, on day 4, the treating clinician believes the patient will require at least 7 more days of ventilatory support
  • Exclusion: If a tracheostomy is already in situ, or one is required for specific patient management (e.g. airway obstruction); chronic hypercarbia from neurological disease
  • 3147 patients assessed of which 909 were randomised.

Intervention

  • Placement of tracheostomy within 4 days of critical care admission
    • 84.6% received tracheostomy as planned
    • 14.5% not managed as planned because:
      • 6.8% never received a tracheostomy (died, too unstable, or recovered)
      • 7.7% received it ‘late’ (too unwell, no resources, transiently improved, trial error)

Control

  • Placement of tracheostomy on or later than day 10, and only then if still deemed clinically indicated
    • 93.6% were managed as per trial protocol
      • 39.9% received tracheostomy on or later than day 10
      • 53.7% were deemed no longer indicated and did not receive a tracheostomy
    • 7.3% received tracheostomy before day 10 (clinical decision, insistence by relatives, trial error)

Outcome

  • Primary outcome: all-cause mortality at 30-days was not statistically different between the two groups
    • Early 30.8% vs late 31.5%
  • Secondary outcome:
    • There were no differences in survival at ICU discharge, hospital discharge, 1-year and 2-year follow-up
    • Duration of mechanical ventilation favoured early tracheostomy but this did not reach statistical significance
      • Early 13.6 days vs late 15.2 days; reduction in mean duration 1.7 days; p=0.06
    • Median length of ICU stay were the same: early 13.0 days vs late 13.1 days
    • Only within the 30-day-surviving sub-group, there were statistically significantly fewer days of sedation administration in the early group: early 5 days vs late 8 days (p<0.001)
    • Antibiotic use (as a proxy for hospital acquired infections) were not different between the two groups
  • Other data:
    • The incidence of complications overall was 6.3% (95% CI 4.6–8.5%), of which bleeding requiring fluid administration was most common
    • 89% were percutaneous and 11% were surgically performed
    • The median duration of the procedures was 30 minutes

Authors’ Conclusions

  • In mechanically ventilated adult patients, there is no mortality benefit from performing an early tracheostomy.

Strengths

  • National study with all centres invited to take part: excellent external validity
  • Robust methodology
  • Meaningful outcome with 2 year follow-up

Weaknesses

  • Recruitment fatigue led to lower than planned patient numbers
  • Did not include patients requiring tracheostomy for non-respiratory reasons, such as neurological disease
  • Did not look at long-term complications and morbidity associated with tracheostomy
  • Inclusion was reliant on clinicians identifying patients at high risk of prolonged ventilation, with no validated scoring system to assist decision making. This study shows that 19.6% recovered before day 10 in the late group, suggesting that clinician judgement is not good for this.

The Bottom Line

  • This trial does not provide evidence supporting early tracheostomies performed around day 4 compared to day 10 (no evidence of difference).
  • Tracheostomy procedures are associated with a 6.3% incidence of complications requiring interventions, which must be weighed against any potential benefit.
  • Many commentators have interpreted this trial to mean there is no benefit from performing early tracheostomies (evidence of no difference), as many will not need it if we wait until day 10.
  • However, some patients need tracheostomies for good reasons (e.g. neurological disease) and they were not included in this study.

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