Historical background
Tracheostomy appears to have been in practice as a life-saving intervention to relieve upper airway obstruction for more than 2,000 years. Descriptions of a throat incision, suggestive of tracheostomy, are found in the sacred Hindu text, the Rig Veda, that dates back to 1500 BCE (1). Alexander the Great, the King of Macedonia who lived between 356–323 BCE, is believed to have used his sword to cut open the throat of one of his soldiers as he lay choking on a piece of meat, on the verge of death. Emergency tracheostomy was often resorted to during the diphtheria epidemics of the 18th and 19thcenturies.
Chevalier Jackson introduced the present-day concept of tracheostomy in the early 20th century. He proposed that “there are several classes of cases in which intubation does not meet the indication and there are frequent individual cases where, for some special reason, the cutting operation is easier, safer and more efficient” (2).
In 1943, Galloway first reported the performance of a tracheostomy for suctioning secretions from the airway in patients with bulbar poliomyelitis. In his paper published in the Journal of the American Medical Association (3), he reported that “The results with 3 patients seen in the past two months have convinced me that the operation may be a very important procedure in this disease. Two were undoubtedly saved by it, and the third might have been had intervention been done ten minutes earlier.” The Scandinavian polio epidemic ushered in the era of ventilatory support through a tracheostomy, with Bjørn Ibsen pioneering the use of positive pressure ventilation, marking a paradigm shift from the technique of negative pressure ventilation that had largely been ineffective (4).
In 1984, Pasquale Ciaglia (Fig 1.) watched in awe as a urologist, ably assisted by his radiologist, removed a renal calculus with consummate ease using the Seldinger technique and a set of serial dilators (5). Inspired by this technique, he performed cadaver dissections and designed a tracheostomy tube that could be introduced over a snugly fitting dilator and a ‘J’-shaped guidewire. His original technique involved a vertical incision from the lower border of the cricoid cartilage. The introducer needle and guidewire were inserted, by palpation, between the cricoid cartilage and the first tracheal ring, or between the first and second tracheal rings. This was followed by serial dilatation and insertion of a flanged tracheostomy tube.
Ciaglia et al. published their seminal paper in 1985. Their preliminary report included 26 procedures, including two patients who underwent repeat tracheostomy (6). They proposed that the percutaneous procedure could be performed through the cricothyroid membrane, between the cricoid and the first tracheal cartilages, or between the first and second tracheal cartilages. The authors did not encounter any serious complications during the procedure. There was occasional difficulty in passing the tracheostomy tube, but this could be overcome by using larger dilators. With increasing experience, and realizing the simplicity of the technique, they began performing the procedure at the bedside in the ICU. Over the next decade, the bedside percutaneous technique was increasingly adopted as the preferred technique in ICU patients by many intensive care physicians.
Over the years, the percutaneous technique became increasingly popular among clinicians with the performance of a tracheostomy earlier in the course of illness (7). An early tracheostomy was considered to improve patient comfort compared to an endotracheal tube and, thereby, had the potential to reduce the use of sedation. Besides, other perceived benefits included earlier weaning and a reduced incidence of ventilator-associated pneumonia (VAP) (8).
Background to the TracMan trial
The availability of ICU beds in the UK is much lower compared to other high-income countries. In many centers, the prevailing trend favored early tracheostomy, with the presumed benefit of reducing the duration of mechanical ventilation and ICU stay. Surveys of UK practice reflected the practice of early tracheostomy; 50% of tracheostomies were carried out within a week of ICU admission while 21% were performed as early as within 5 days of admission (9,10).
In 2004, a randomized controlled trial (RCT) of 120 patients from the US suggested that early tracheostomy with 48 hours of intubation compared with later tracheostomy between 14–16 days of intubation resulted in a significantly reduced duration of mechanical ventilation and lower mortality (11). A meta-analysis of 406 patients from five studies followed; early tracheostomy was found to reduce the duration of mechanical ventilation, although the mortality was similar (12). The TracMan (Tracheostomy Management) trial was conceived in light of these findings considering the potential benefit of early tracheostomy in a healthcare system with a constraint on ICU beds.
Population and design
The TracMan trial was conducted during a 4-year period between November 2004 and November 2008 across 82 hospitals, including 70 general and two cardiothoracic surgical ICUs in the UK. The study included patients within the first 4 days of ICU admission who were on mechanical ventilation and likely to require continued ventilator support for at least 7 more days based on clinician judgment. The study excluded patients in whom an urgent life-saving tracheostomy was required and those with a contraindication to tracheostomy. Patients who were deemed to require early tracheostomy due to chronic neurological disease were also excluded. The study patients were randomly assigned in a 1:1 ratio to undergo an early tracheostomy or late tracheostomy. The planned sample size was 1692 patients, assuming a 6.3% absolute reduction in the 30-day all-cause mortality (13).
Early vs. late tracheostomy
In the early group, tracheostomy was planned to be carried out within 4 days of ICU admission. In the late group, tracheostomy was planned on day 10 or later of ICU admission if it was still considered appropriate by the treating clinician. The chosen technique, whether bedside percutaneous or open tracheostomy, was based on the practice at the participating unit.
Results
After 4 years of the commencement of the study, there was a gradual decline in patient recruitment with exhaustion of funds. Hence, the final sample included only 899 patients, compared with the calculated sample size of 1692 patients. The reduced sample had 80% power to detect an 8.3% reduction in the 30-day all-cause mortality in the early group with a significance level of 5%.
The intention-to-treat analysis included 451 patients in the early tracheostomy group and 448 patients in the late group. The baseline characteristics were similar between the two groups. A total of 622 tracheostomies were performed during the study, including 418 in the early and 204 in the late group. A bedside percutaneous tracheostomy was performed in 551 (88.7%) cases. Among 455 patients randomized to the early group, 385 (84.6%) underwent tracheostomy within 4 days of ICU admission as planned. Sixty-six patients randomized to the early group did not undergo early tracheostomy. Among them, 35 underwent a late tracheostomy, while 31 did not require a tracheostomy. In 33 patients (7.3%) assigned to the late group, tracheostomy was performed before day 10.
Among the 454 patients randomized to the late group, 244 (53.7%) did not undergo tracheostomy. The majority of patients who did not undergo tracheostomy included those who were discharged alive from the ICU (89 patients), weaned off ventilator support (78 patients), or died (54 patients). Eleven patients were too unstable to undergo the procedure, while two were offered end-of-life care. In 10 patients, no clear reason was discernible for not performing a tracheostomy.
Outcomes
The 30-day all-cause mortality, the primary outcome, was similar between the two groups. The mortality was 30.8% in the early compared with 31.5% in the late group. The ICU and hospital mortality and the mortality at 1 and 2 years were also not significantly different between the two groups. The duration of stay in the ICU and in hospital were also similar between the two groups. Among 30-day survivors, the median number of days on sedation was significantly lower with early tracheostomy (5 [IQR: 3–9] vs. 8 [IQR 4–12]) days. In contrast, among non-survivors at 30 days, there was no significant difference in the number of days on sedation.
The TracMan trial revealed no improvement in survival, ICU or hospital stay among general critically ill patients who underwent a tracheostomy within 4 days of ICU admission compared to a wait-and-watch policy until day 10. Among patients assigned to the late group, the majority did not undergo tracheostomy. Thus, the study revealed that a delayed approach could avert an unnecessary procedure in the majority of patients.
Clinically significant bleeding requiring intravenous fluids or other active intervention occurred in 7% of patients. In the early group, 11 (2.6%) patients experienced bleeding compared to eight patients in the late group (3.9%).
Limitations
The TracMan trial could not attain the projected sample size as recruitment slowed down over time, leading to an underpowered study. The study centers, on average, recruited just two patients per year, suggesting a large number of exclusions for reasons that are largely unclear. Patients with respiratory failure due to chronic neurological disease were excluded, as the existing practice was to perform an early tracheostomy in these patients. The eligibility for inclusion in the study was based on clinician judgment regarding the requirement for prolonged ventilation; no validated tool was used to assist with the decision-making.
Comments
The TracMan trial was the largest RCT that addressed the timing of tracheostomy in ICU patients. The study employed a robust methodology and evaluated relevant clinical outcomes. Although the trial did not provide evidence regarding the optimal timing of tracheostomy in a heterogenous group of critically ill patients, it demonstrated that an early tracheostomy within the first 4 days does not improve clinical outcomes, compared to waiting for a minimum of 10 day after ICU admission.
The decision to perform a tracheostomy depends on clinical judgment regarding the need for prolonged mechanical ventilation. The TracMan trial clearly demonstrated that this is no easy task; 89/454 (19.6%) patients considered to require prolonged ventilation, and randomized to the late group, were weaned off ventilator support and discharged from the ICU by day 10. Clearly, an early tracheostomy within the first 4 days may involve performing an unnecessary and potentially risky procedure on a significant number of patients. The study highlights the need for a validated tool that may help clinicians predict the need to prolonged mechanical ventilation and tracheostomy. In the absence of objective guidance, it is probably appropriate to wait for 10 days or longer for a clearer picture to emerge regarding the trajectory of illness.
Summary
The timing of tracheostomy had long been the subject of debate among intensivists. Prior to the TracMan trial, an RCT of a small sample size had revealed improved survival, reduced ICU length of stay, a shorter duration of mechanical ventilation, and a lower incidence of ventilator-associated pneumonia (VAP) with an early tracheostomy (14). Subsequently, an Italian RCT found no difference in the incidence of VAP; however, it suggested significantly more ventilator and ICU-free days, and a higher likelihood of weaning with early tracheostomy. In the largest RCT so far that evaluated the timing of tracheostomy, the TracMan trial provided robust evidence that performing a tracheostomy within 4 days of admission is unlikely to improve clinical outcomes, including mortality and the duration of stay in the ICU or hospital.
References
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