Early Tracheotomy is Not Associated with Improved Mortality and Morbidity

Early Tracheotomy is Not Associated with Improved Mortality and Morbidity

Abstract & Commentary

By Betty Tran, MD, MS

Assistant Professor of Medicine, Pulmonary and Critical Care Medicine, Rush University Medical Center, Chicago

Dr. Tran reports no financial relationships relevant to this field of study.

SYNOPSIS: This multicenter, randomized trial of university and non-university ICUs in the United Kingdom found that tracheotomy within 4 days of critical care admission compared to late tracheotomy (≥ 10 days) was not associated with an improvement in 30-day, 1-year, or 2-year mortality, length of ICU stay, or antibiotic-free days.

SOURCE: Young D, et al. Effect of early vs. late tracheostomy placement on survival in patients receiving mechanical ventilation: The TracMan randomized trial. JAMA 2013;309:2121-2129.

The Tracheostomy Management (TracMan) study enrolled adult patients receiving mechanical ventilation in 70 general and two cardiothoracic surgical ICUs from both university and non-university hospitals across the United Kingdom between 2004 and 2008 who were deemed by their treating physicians within the first 4 days of admission to be likely to require at least 7 more days of ventilatory support. Of the 1032 eligible patients, 909 were ultimately randomized 1:1 to receive early tracheotomy (within 4 days of randomization) or late tracheotomy (after 10 days, if still clinically indicated). The primary outcome was all-cause 30-day mortality, with secondary outcome measures being mortality at ICU discharge, 1 and 2 years, ICU and acute hospital length of stay, number of days receiving sedatives, and antimicrobial-free days.

There was no significant difference in 30-day mortality between the early vs late tracheotomy group (absolute risk reduction 0.7; 95% confidence interval, -5.4-6.7, P = 0.89). ICU and acute-hospital lengths of stay and 1- and 2-year survival rates were also similar between the two groups. Median duration of ICU admission was similar at 13.0 (IQR 8.2-19.1) days in the early group compared to 13.1 (IQR 7.4-23.6) days in the late group (P = 0.74), with comparable median total hospital length of stay (33 vs 34 days, respectively, P = 0.68). In patients who survived to 30 days after randomization, there was a significant difference in the number of days sedatives were given in the early tracheotomy group (5 days, IQR 3-9) vs the late group (8 days, IQR 4-12; P < 0.001), but no difference in sedative use when patients not surviving to 30 days were compared and no overall difference in antibiotic use.

Notably, in the late tracheotomy group, only 45% of patients ultimately underwent the procedure. In more than two-thirds of the rest, a tracheotomy was no longer clinically indicated because the patient had recovered with no further mechanical ventilatory needs or had been discharged alive from the ICU. Interestingly, the investigators attempted but were unable to generate a validated and accurate prediction tool that could help determine the duration of mechanical ventilation for an individual patient. However, when compared to other studies with published predictive "rules," the rate at which patients recovered before tracheotomy remained similar at approximately 20%, suggesting that any rules used were no better than clinical judgment.

COMMENTARY

Although this study lost some power when it did not reach its target sample enrollment (the authors originally planned for 1208 patients, then revised it to 1692, and ended up with a final sample of 899), it remains the largest randomized trial to date and is probably the best data we currently have in the debate between early vs late tracheotomy. As the authors point out, this question is critical in the United Kingdom given the pressures to pursue early tracheotomy due to limited ICU beds and increased severity of illness among patients admitted to the ICU; they quote one U.K. survey that revealed half of all tracheotomies were performed within 1 week of ICU admission.

Not only was there no survival advantage or other significant length of stay benefits to early tracheotomy compared to a late "watchful waiting" policy, but the observation that only 45% of patients in the late group ultimately underwent tracheostomy placement mainly due to successful extubation and subsequent ICU discharge suggests that an early strategy will lead to a large number of unnecessary tracheotomies with inherent procedure risks. Although the tracheotomy complication rate in the study was relatively low at 6.3%, this may not be generalizable to other centers as the vast majority of tracheotomies performed in these cases were percutaneous, dilator-based ones done at bedside. In addition, this observation highlights our current inability to predict accurately who will need prolonged mechanical ventilation. One can argue, however, that robust prediction tools may not be vital as based on the study findings, delaying decisions about tracheotomy until at least day 10 was not associated with any significant increase in morbidity or mortality.

EDIToR's COMMENTARY

David J. Pierson, MD

This study brings us a bit closer to resolving a longstanding and hotly debated issue in ICU management: when and why to perform a tracheotomy on a mechanically ventilated patient with acute respiratory failure. Nearly two decades ago, during Critical Care Alert’s first year of publication, Leslie Hoffman wrote a special feature summarizing the pros and cons of early vs late tracheotomy, primarily from the perspective of complications.¹ Since then, bedside percutaneous dilational tracheotomy has made the procedure accessible to non-surgical intensivists and become standard of care in many centers. In addition, noninvasive ventilation has expanded the options for full- or part-time ventilatory support for some patients who need this long term. However, when and why to do a tracheotomy remain common and contentious questions in the management of many critically ill patients.

There are two main reasons why this issue remains problematic after 40 years. The first is the lack of an effective means for identifying up-front which patients will need prolonged ventilatory support.² Many studies have attempted to devise criteria that could be applied within a day or two of intubation to predict subsequent weaning failure and the continued need for invasive mechanical ventilation two or more weeks later. As in the present study, such predictive criteria have invariably identified many patients as needing prolonged ventilation who are in fact extubated successfully during the next week or two. Except for a few highly specific circumstances (such as in some high cervical spinal cord injuries), performing tracheotomies within the first few days of intubation will invariably mean doing this procedure on some patients who do not actually need it.

The second reason is the absence of equipoise among intensivists with respect to the timing of tracheotomy, including researchers who attempt to study it.² In order for a randomized clinical trial to succeed, investigators must agree to apply both study arms, and patients have to be allotted equally to the two treatments being evaluated. With respect to when patients should undergo tracheotomy, despite the absence of definitive scientific evidence, every practitioner and potential investigator seems to feel strongly enough about one or the other of the options to be bothered ethically by the idea of randomizing half their patients to receive the other option. The result in nearly all previous studies has been disrupted randomization, protocol violations, and/or failure to enroll sufficient patients, such that the primary research question cannot be answered definitively. As indicated above by Dr. Tran, the present study by Young and colleagues helps to resolve the dilemma with its finding that waiting at least 10 days to decide whether to do a tracheotomy, if the patient still requires airway access and ventilatory support at that point, does not seem to be harmful.

The three most compelling reasons for tracheotomy in a patient with acute respiratory failure remain: 1) facilitation of airway clearance; 2) airway access for long-term mechanical ventilation when noninvasive ventilation is not an option; and 3) facilitation of communication in patients who are awake, alert, and capable of speaking. For patients in whom one or more of these conditions exist, most intensivists consider tracheotomy when it appears after 1-3 weeks that extubation will not be successful or safe in the near future. A caveat, however, is that we have learned from many studies on weaning that liberation from ventilatory support cannot be predicted with certainty without (usually several) empirical trials of spontaneous breathing.

REFERENCES

1. Hoffman LH. Timing of tracheotomy: Influence on outcomes. Critical Care Alert 1994;1(11):86-88.
2. Pierson DJ. Tracheostomy and weaning. Respir Care 2005;50: 526-533.