Early tracheostomy does not improve survival or other outcomes (TracMan trial)

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Early Tracheostomy Does Not Help in Large "TracMan" Trial

More than 100,000 tracheostomies are performed worldwide each year for people requiring prolonged periods of mechanical ventilation. It's generally agreed that to avoid damaging the trachea and throat, a tracheostomy should be placed within 3 weeks of mechanical ventilation. But prior to 3 weeks, it's been anybody's guess when it's best to perform tracheostomy. Individual randomized trials have mostly shown no benefit of "early" tracheostomy (within a week or so), but a 2005 meta-analysis in BMJ of 5 trials (n=406) concluded early tracheostomies shorten ICU stays and ventilator dependence. A  2011 meta-analysis in Chest including 700 more patients from 2 later trials found no benefit of early tracheostomy, but showed trends toward reduced sedation and ICU/ventilator days.

Lacking conclusive data, physicians have been free to follow their own whim, personal interpretation of the evidence, and local financial influences. Citing tracheostomies' potential benefits of patient comfort and reduced use of sedation, leading to (possibly) faster ventilator weaning and ICU discharge, some physicians "trach" patients within 2 days of arrival in the ICU. Stroke patients are often "trach'ed" early for comfort and to prevent brain-straining cough. In the medical ICU, most doctors delay tracheostomy until 10 to 14 days, giving their patients a fighting chance to escape the ventilator without a potentially unnecessary surgery. But Medicare and insurance companies create an unfortunate incentive to trach early, by allowing hospitals to "up-code" to higher-paying diagnosis-related-groups (DRGs) for patients getting tracheostomies in the hospital.

In the U.K., rationing not only isn't a dirty word, it's the national health policy. There are one-seventh the number of ICU beds per capita as the U.S.; most of theirs are filled by mechanically ventilated patients. Early tracheostomy, if beneficial, could bring major benefits to patients as well as the ICU and hospital systems. In May 2013, after much anticipation, Duncan Young et al published in JAMA the results of the TracMan trial to help answer a question that's become a bit of a pain in the neck: When to trach?

What They Did

Investigators randomized 909 patients at 72 centers in the U.K., ventilated less than 5 days and expected to need 7+ more days of mechanical ventilation, to undergo tracheostomy either immediately or at 10 days of mechanical ventilation. Most were percutaneous tracheostomies.

The enrollment target was revised to 1,600 patients as a pilot period revealed their power to detect a mortality difference was lower than predicted. They never reached this target due to "recruitment fatigue" (their phrase), and running out of funding, with the result that TracMan's power could only identify an 8% absolute difference in 30-day mortality with 80% power and 5% alpha error.

What They Found

Nearly all (92%) of the early-group patients received a tracheostomy, while only 45% in the late group did. In the late group, most of the other surviving patients didn't need a tracheostomy by day 10 because they were successfully extubated.

There was no proven difference between groups in 30-day mortality (30.8% early vs. 31.5% late, primary outcome), nor in any other outcome including 2-year mortality. Patients getting early tracheostomies required fewer days of sedation, and there was a suggestion of a reduction of -1.7 ventilator days with early trach (mean 13.6 days vs 15.2 days, p=0.06). However, ICU stays were exactly equal at a median 13 days.

Also, 7% of patients had significant bleeding attributed to their tracheostomies (defined as needing IV fluids or another intervention); this amounted to 11 patients in the early group and 8 in the late group.

What It Means

For most patients with prolonged respiratory failure, an overwhelming preponderance of the evidence now shows no demonstrable benefit of performing tracheostomy early rather than waiting at least 10 days to see if a patient can escape the ventilator under her own power.

This study did not include neurocritical care units, but it's worth mentioning that while early trach is a common practice in catastrophic stroke and brain trauma victims, its benefits are unclear in those patients, as well.

One signal is clear and consistent across all randomized trials testing early vs. late tracheostomy, including TracMan: a large proportion of tracheostomies performed for prolonged respiratory failure are unnecessary. With a few more days of good care and daily spontaneous breathing trials, this large group of patients will escape the ventilator and the ICU without a hole in their necks. Although TracMan was technically underpowered, it was still a big trial, and given its findings along with those of the 5+ smaller but concordant randomized trials, the likelihood of a benefit of early tracheostomy that's meaningful enough to justify unnecessary tracheostomies in 20-50% of patients undergoing prolonged mechanical ventilation is hard to imagine.

There are multiple pressures to perform trachs early, the most important and obvious being that they pay more -- thousands of dollars more to the hospital per patient. The interventionalist service (often pulmonary or ENT) that performs the trachs becomes a profit center, with the resultant perks that go with that. And patients seem to be progressing when they get trachs, and they certainly are more comfortable.

The only hang-up is, there's a good chance they never needed a tracheostomy at all.

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Duncan Young et al. Effect of Early vs Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation: The TracMan Randomized Trial. JAMA 2013;309(20):2121-2129.