The debate of early vs. late tracheostomy is far from settled. Two recent (2015) meta-analysis reviews have come to slightly different conclusions about the effect of early tracheostomy on mortality. It seems to have either little effect or no effect on mortality, no effect on the length of ICu stay, and no effect on the duration of mechanical ventilation. There is marked heterogeneity in the trials, suggesting that there is probably a population who benefit from early tracheostomy (eg. burns, trauma, stroke) and a population who can wait for a chance of extubation.
Question 13 from the first paper of 2013 and the near-identical Question 13 from the second paper of 2017 asked the candidates to "critically evaluate the timing of elective tracheostomy in adult Intensive Care patients". This SAQ was quite unique among the CICM papers, because the model answer makes reference to TracMan, a trial which had not yet been published at the time of the exam. This question may never appear again because this issue is far from settled, and because the evidence is conflicting. It is unlikely that the examiners will ever ask about this again because it will be difficult to mark. If this question were repeated in future papers, modern data expected of the candidates would probably come from the 2015 meta-analysis article by Andriolo et al and Szakmany et al, which arrived at essentially the same conclusions (in three words, early vs late tracheostomy makes no difference to any parameters of interest when you homogenise the ICU population),
The college answer to Question 13 reports that tracheostomy "may be considered as “early” at <10 days or “late” >10 days", which is a definition probably adopted from the 2012 Cochrane review by Gomes et al. Unfortunately, there is no "gold standard" beyond this one: essentially, trial authors have been free to use any arbitrary definitions. In the modern era one might expect that all future studies of this topic will expect to be compared to TracMan, and will therefore use the same 10 day threshold.
One might ask, why do we even bother? In the absence of strong evidence, intensivists will do whatever the hell they want, guided by concerns of patient comfort, futility versus beneficence, local hospital policy or even financial incentive (see the bit about "up-coding" in the PulmCCM article). And what's wrong with that? Surely it is better to the individualise the decisionmaking, rather than to broadly extend tracheostomy to all patients on the basis of generic trial evidence?
In fact, there are multiple reasons to investigate the timing of tracheostomy. For the purpose of exam revision, these may be summarised as points:
A Cochrane review from 2012 (Gomes et al) is a good representation of the data which existed at this stage, and which would have been familiar to the exam candidates writing an answer to Question 13 from the first paper of 2013. In fact it might have been the stimulus for the examiner who wrote that specific SAQ. In brief, the systematic review had found four studies worth analysing. In total, 673 patients from four trials were scraped together. The findings of the analysis were as follows:
However, the reviewers excluded a study where 8 days (not 10) was used as the definition threshold for early vs. late, as well as excluding six studies which specifically compared early tracheostomy with prolonged intubation. There was such heterogeneity of findings among the four remaining trials that Gomes et al were unable to pool the data. "Evidence is of low quality" they complained; "potential differences between early and late tracheostomy need to be better investigated by means of randomized controlled trials".
In response to the desperate need for high quality trials, TracMan enrolled 909 patients from 72 British ICUs. The above-linked PulmCCM article dissected it in detail, and there are some useful comments by the audience at the end. In brief, the study had the following features:
Later, the abovementioned Cochrane review has been revisited by Andriolo et al (2015). In the three years since the last review, more RCTs were performed and eight studies were included (n=1977, of which 909 were from TracMan). The analysis results were as follows:
Another (non-Cochrane) meta-analysis was performed by Szakmany et al (2015), with n= 2406. The only difference in their findings was an absence of mortality difference; in most other respect this analysis replicated the findings by Andriolo et al.
Bösel et al (2022) came back to the themes of TracMan to see whether there is any benefit of early treacheostomy in a population whose need for tracheostomy is already predictable from an early stage - severe stroke patients. Their findings and conclusions are scrutinised at thebottomline.org.uk with characteristic rigor. In brief summary:
One take home message here is the implications of the last point. About 33% of the late tracheostomy patients never ended up getting their late tracheostomy. This means that for them an early tracheostomy would have been an unnecessary procedure, a potentially avoidable source of complications and morbidity.
For the modern era, the review article on this topic by Longworth et al (2016) is an excellent example of the evolution of this discussion. We no longer ask "when", but rather "who" when it comes to tracheostomy timing. Cleary some groups derive greater advantage than others. This is an issue which may be neglected by the large all-comer trials. In summary:
Huang, Huibin, et al. "Timing of Tracheostomy in Critically Ill Patients: A Meta-Analysis." PloS one 9.3 (2014): e92981.
Young, Duncan, et al. "Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial." Jama 309.20 (2013): 2121-2129.
Longworth, Aisling, et al. "Tracheostomy in special groups of critically ill patients: Who, when, and where?." Indian Journal of Critical Care Medicine 20.5 (2016): 280.
Baron, David Marek, et al. "Tracheostomy is associated with decreased hospital mortality after moderate or severe isolated traumatic brain injury." Wiener klinische Wochenschrift (2016): 1-7.
Hosokawa, Koji, et al. "Timing of tracheotomy in ICU patients: a systematic review of randomized controlled trials." Critical Care 19.1 (2015): 1-12.
Gomes Silva, Brenda Nazaré, et al. "Early versus late tracheostomy for critically ill patients." Cochrane Database Syst Rev 3 (2012).
Andriolo, B. N., et al. "Early versus late tracheostomy for critically ill patients." Cochrane Database Syst Rev 1 (2015).
Szakmany, T., et al. "Effect of early tracheostomy on resource utilization and clinical outcomes in critically ill patients: meta-analysis of randomized controlled trials." British journal of anaesthesia 114.3 (2015): 396-405.
Bösel, Julian, et al. "Effect of early vs standard approach to tracheostomy on functional outcome at 6 months among patients with severe stroke receiving mechanical ventilation: the SETPOINT2 Randomized Clinical Trial." JAMA 327.19 (2022): 1899-1909.
Schönenberger, Silvia, et al. "The SETscore to predict tracheostomy need in cerebrovascular neurocritical care patients." Neurocritical care 25.1 (2016): 94-104.