Early vs Late Tracheotomy for Prevention of Pneumonia in Mechanically Ventilated Adult ICU Patients A Randomized Controlled Trial

Anestesia e Rianimazione 1, Ospedale S. Giovanni Battista, Università di Torino, Turin, Italy.
JAMA The Journal of the American Medical Association (Impact Factor: 30.39). 04/2010; 303(15):1483-9. DOI: 10.1001/jama.2010.447
Source: PubMed

ABSTRACT Tracheotomy is used to replace endotracheal intubation in patients requiring prolonged ventilation; however, there is considerable variability in the time considered optimal for performing tracheotomy. This is of clinical importance because timing is a key criterion for performing a tracheotomy and patients who receive one require a large amount of health care resources.
To determine the effectiveness of early tracheotomy (after 6-8 days of laryngeal intubation) compared with late tracheotomy (after 13-15 days of laryngeal intubation) in reducing the incidence of pneumonia and increasing the number of ventilator-free and intensive care unit (ICU)-free days.
Randomized controlled trial performed in 12 Italian ICUs from June 2004 to June 2008 of 600 adult patients enrolled without lung infection, who had been ventilated for 24 hours, had a Simplified Acute Physiology Score II between 35 and 65, and had a sequential organ failure assessment score of 5 or greater.
Patients who had worsening of respiratory conditions, unchanged or worse sequential organ failure assessment score, and no pneumonia 48 hours after inclusion were randomized to early tracheotomy (n = 209; 145 received tracheotomy) or late tracheotomy (n = 210; 119 received tracheotomy).
The primary endpoint was incidence of ventilator-associated pneumonia; secondary endpoints during the 28 days immediately following randomization were number of ventilator-free days, number of ICU-free days, and number of patients in each group who were still alive.
Ventilator-associated pneumonia was observed in 30 patients in the early tracheotomy group (14%; 95% confidence interval [CI], 10%-19%) and in 44 patients in the late tracheotomy group (21%; 95% CI, 15%-26%) (P = .07). During the 28 days immediately following randomization, the hazard ratio of developing ventilator-associated pneumonia was 0.66 (95% CI, 0.42-1.04), remaining connected to the ventilator was 0.70 (95% CI, 0.56-0.87), remaining in the ICU was 0.73 (95% CI, 0.55-0.97), and dying was 0.80 (95% CI, 0.56-1.15).
Among mechanically ventilated adult ICU patients, early tracheotomy compared with late tracheotomy did not result in statistically significant improvement in incidence of ventilator-associated pneumonia. Identifier: NCT00262431.

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Available from: Massimo Antonelli, Aug 24, 2015
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    • "Additional measures to decrease VAP include daily vacation sedation to examine readiness for extubation, management of upper airway secretions with closed aspiration systems, and strict control of endotracheal-tube cuff pressures, policies related to hand hygiene, head elevation at 45 • , oral hygiene with chlorhexidine preparations, along with stress ulcer prophylaxis with H2 or proton-pump inhibitors [19]. Though neurological patients experience more early tracheotomies in general [1], this practice has not been associated with improved patient outcomes, particularly mortality or onset of VAP [20] [21]. Accumulation of fluid in the pleural space and bacterial infection may result in empyema. "
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    Critical care research and practice 10/2012; 2012:207247. DOI:10.1155/2012/207247
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    • "There are active ongoing debates about performing early vs late tracheostomy for longterm ventilator-dependent patients. Although the issue of timing of tracheostomy is receiving significant attention [2] [3] [4], few studies have focused on the difficult question of whether an individual patient should undergo tracheostomy at all [5] [6]. Before performing PDT, it is crucial for physicians, patients, and their surrogates to assess prognosis and goals of care. "
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    ABSTRACT: The purpose of the study was to identify the predictors of short-term mortality in patients undergoing percutaneous dilatational tracheostomy (PDT). Retrospective analysis of data pertaining to adult patients who underwent PDT between July 2005 and June 2008 in an urban, academic, tertiary care medical center was done. Clinical and demographic data were analyzed for 483 patients undergoing PDT via multivariate logistic regression. Mortality data were examined at in-hospital, 14, 30, and 180 days postprocedure. Overall mortality rates were 11% at 14 days, 19% at 30 days, and 40% at 180 days. In-hospital mortality was 30%. Patients undergoing PDT have significant short-term mortality with 11% dying within 14 days and an in-hospital mortality rate of 30%. We identified an index diagnosis of ventilator-associated pneumonia and trauma to be associated with a higher survival rate, whereas older age, oncological diagnosis, cardiogenic shock, and ventricular-assist devices were associated with higher mortality. There is significant heterogeneity in both underlying diagnosis and patient outcomes, and these factors should be considered when deciding to perform this procedure and discussed with patients/family members to provide a realistic expectation of potential prognosis.
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    ABSTRACT: Le bénéfice attendu d’une trachéotomie est la diminution des complications ou gênes liées à une intubation prolongée, telles que les lésions laryngotrachéales, les infections pulmonaires et sinusiennes, l’inconfort, la sédation-analgésie et le risque d’autoextubation. En la réalisant précocement, en pratique avant le septième jour, des études non randomisées avaient suggéré une diminution de la durée de ventilation, voire une réduction de la mortalité. En 2004, un essai randomisé, portant sur une population de malades médicaux sévères, avait trouvé des résultats très positifs relançant la controverse. Depuis cette date, au moins neuf essais ont été lancés. Les trois derniers, TracMan, ETOC et un essai italien sont arrivés à leur terme et ont été présentés en 2009. Ils n’ont montré aucun bénéfice de la trachéotomie précoce, comparée à une trachéotomie éventuelle différée, sur la mortalité, la durée de ventilation (sauf pour l’essai italien) la durée d’hospitalisation et la survenue d’infections pulmonaires. Cependant, deux des essais ont confirmé une diminution du recours à la sédation-analgésie. Ces trois études incluant plus de 1 500 patients, ajoutées à cinq autres essais randomisés globalement négatifs, méthodologiquement moins robustes, permettent de clore le débat. Il n’y a pas d’intérêt, ni sur le plan du pronostic vital ni sur le plan de la durée de ventilation mécanique (VM), à réaliser une trachéotomie précoce, et cela, quelle que soit la population réanimée. Étant entendu que les bénéfices de la trachéotomie sont d’ordre « secondaire », il reste désormais à déterminer chez quels patients réaliser ce geste invasif et pourquoi. The expected benefit of a tracheotomy is the reduction in complications associated with prolonged intubation such as laryngotracheal injuries, ventilator-associated pneumonia, sinusitis, discomfort, sedation-analgesia and risk of self-extubation. Retrospective and non-randomized studies have reported a decrease in duration of mechanical ventilation and even in mortality may occur if tracheotomy is performed early, before the seventh day post-intubation. In 2004, a randomized trial including severely critically ill patients in 3 ICUs found very positive results, reopening the controversy. Since this date, at least nine randomized trials have been conducted. The last three trials, TracMan, ETOC and the Italian trial, reached their terms, and their results are now available. They have shown no particular benefit for early tracheotomy as opposed to late tracheotomy in terms of mortality, ventilation duration (except for the Italian trial) length of the hospitalization stay and ventilator-associated pneumonia. However, two of them have confirmed a decrease in sedation analgesia. These three studies involving more than 1,500 patients, associated with five other globally negative trials, allow closing the controversy. There is no interest to perform an early tracheotomy, neither in terms of vital prognosis nor in terms of the duration of mechanical ventilation, however critically ill the patient is. Because benefits of tracheotomy are of “secondary importance”, it is now mandatory to determine for which patients this invasive procedure is relevant and why. Mots clésTrachéotomie–Ventilation mécanique–Mortalité–Réanimation KeywordsTracheotomy–Mechanical ventilation–Mortality–Intensive care unit
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