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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Since the 1970s&#44;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> different comparative studies have tried to answer this question&#46; The two randomized&#44; prospective multicenter trials with the largest sample size to date have been published during the last 5 years&#46; In the first of them&#44; Terragni et al&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> included 419 patients&#44; of which 209 were randomized to early tracheotomy &#40;after 6&#8211;8 days of translaryngeal intubation &#91;TI&#93;&#41; and 210 to late tracheotomy &#40;after 13&#8211;15 days of TI&#41;&#46; The primary endpoint was the incidence of ventilator-associated pneumonia &#40;VAP&#41;&#46; The authors found no differences between the two groups in terms of either the primary endpoint or mortality after 28 days &#40;secondary endpoint&#41;&#46; The overall complications rate was 39&#37;&#44; though the majority were only minor problems&#46; The second and most recent study was published by Young et al&#46; &#40;The TracMan randomized trial&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> and included 909 patients&#44; of which 455 were randomized to early tracheotomy &#40;during the first 4 days of TI&#41; and 454 to late tracheotomy &#40;after 10 days of TI&#41;&#46; There were no differences between the two groups in terms of mortality 30 days after randomization &#40;primary endpoint&#41; or as regards in-hospital mortality or mortality after one and two years of follow-up&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the study published by Terragni et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> 17&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>36&#41; of the patients randomized to early tracheotomy and 20&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; of those randomized to late tracheotomy were finally not subjected to tracheotomy&#44; due to blood gas improvement and resolution of the acute disease process that led them to require mechanical ventilation in the first place&#46; The authors underscored that the anticipation of tracheotomy increased the number of patients who were finally tracheotomized&#46; In the study published by Young et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> 14&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>66&#41; of the patients in the early tracheotomy group were not tracheotomized &#40;15 because of recovery&#41;&#44; while a full 55&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>244&#41; of the patients in the late tracheotomy arm were not tracheotomized&#8211;fundamentally due to extubation and discharge from the Intensive Care Unit&#46; As commented by the authors&#44; this situation questions the capacity of clinicians to establish an early prediction of the duration of mechanical ventilation beyond a period of 7 days&#46; Both studies conclude that early tracheotomy should be avoided&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The results of these two large studies are in contrast to the data published in 2004 by Rumbak et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a> who in a randomized&#44; prospective analysis of a smaller patient sample &#40;120 medical critical patients&#58; 60 in each arm&#41; with screening criteria that do not allow generalization of the results&#44; found early tracheotomy &#40;performed after 48<span class="elsevierStyleHsp" style=""></span>h of ventilation&#41; to be associated to lesser mortality and VAP than tracheotomy performed beyond 14 days of ventilation&#46; Eight of the 60 patients &#40;13&#37;&#41; randomized to late tracheotomy were finally not tracheotomized due to extubation before day 14&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The last article published in relation to this controversial issue is a recent metaanalysis<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">5</span></a> including 11 randomized&#44; prospective trials&#46; The conclusions were that tracheostomy performed in the first 7 days of ventilation is associated to a shorter stay in the Intensive Care Unit&#44; though without differences in terms of in-hospital mortality&#46; Consequently&#44; there is no evidence in support of an early tracheotomy strategy&#46; Accuracy in predicting the duration of mechanical ventilation was cited as an important limitation of all the studies evaluated&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">In effect&#44; all the published comparative studies present the same limitation&#44; for which no solution is currently available&#58; the lack of a validated instrument for predicting prolonged mechanical ventilation&#46; As a result&#44; patient screening for inclusion has been based on subjective criteria&#46; This situation in turn has led to recruitment problems in some studies&#44; due to difficulties in anticipating the duration of ventilation&#44; or because of clinician reluctance to follow the randomization protocols&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">6&#44;7</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">In 2014&#44; Figueroa-Casas et al&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> published the results of a prospective study designed to evaluate the capacity to establish an early prediction of the duration of mechanical ventilation based on clinical judgment&#46; The analysis of the accuracy of clinical prediction during the first 48<span class="elsevierStyleHsp" style=""></span>h of intubation revealed a sensitivity of 40&#37; for mechanical ventilation lasting over 7 days&#44; versus 29&#37; for mechanical ventilation lasting over 14 days&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In 2007 we started a project designed to develop a predictive model capable of offering help in the clinical decision making process&#44; fundamentally as regards the timing of tracheotomy in ventilated patients&#44; and which was published in this journal in 2012&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> The study&#44; completed before the estimated sample size was reached&#44; and lacking the required statistical power&#44; was unable to meet the expectations&#46; Other studies in this same line have likewise been unable to define a model applicable to the clinical setting&#46; There is only a predictive equation validated for burn patients&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> but not applicable to other critical patients&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">In view of the current state of this topic&#44; the latest publications<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2&#8211;4</span></a> represent &#40;or should represent&#41; the end of comparative &#8220;early versus late tracheostomy&#8221; analyses&#46; Future evaluations in this same line cannot draw solid conclusions if no validated predictive instrument is available&#46; The lack of such an instrument results in methodological weaknesses that invalidate the findings of the studies&#46; Furthermore&#44; considering the poor clinical predictive capacity and the lack of a helping instrument&#44; would it be reasonable to plan new projects a priori assuming that a number of patients are very likely to undergo needless surgery&#44; with the sole justification of having been randomized to a given study arm&#63;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The time has come for a change in direction&#46; If we want to obtain a solid answer to the question of this &#8220;Point of view&#8221;&#44; we first will have to spend years of research in predictive models&#46; This is no easy task&#46; In the meantime&#44; the individualization of decisions remains the best strategy in routine clinical practice&#46;</p></span>"
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Does early versus late tracheotomy afford benefits in ventilated patients?
¿Aporta beneficios la traqueotomía precoz frente a la tardía en el enfermo ventilado?
J.M. Añón
Servicio de Medicina Intensiva, Hospital Virgen de la Luz, Cuenca, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Since the 1970s&#44;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> different comparative studies have tried to answer this question&#46; The two randomized&#44; prospective multicenter trials with the largest sample size to date have been published during the last 5 years&#46; In the first of them&#44; Terragni et al&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> included 419 patients&#44; of which 209 were randomized to early tracheotomy &#40;after 6&#8211;8 days of translaryngeal intubation &#91;TI&#93;&#41; and 210 to late tracheotomy &#40;after 13&#8211;15 days of TI&#41;&#46; The primary endpoint was the incidence of ventilator-associated pneumonia &#40;VAP&#41;&#46; The authors found no differences between the two groups in terms of either the primary endpoint or mortality after 28 days &#40;secondary endpoint&#41;&#46; The overall complications rate was 39&#37;&#44; though the majority were only minor problems&#46; The second and most recent study was published by Young et al&#46; &#40;The TracMan randomized trial&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> and included 909 patients&#44; of which 455 were randomized to early tracheotomy &#40;during the first 4 days of TI&#41; and 454 to late tracheotomy &#40;after 10 days of TI&#41;&#46; There were no differences between the two groups in terms of mortality 30 days after randomization &#40;primary endpoint&#41; or as regards in-hospital mortality or mortality after one and two years of follow-up&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the study published by Terragni et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> 17&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>36&#41; of the patients randomized to early tracheotomy and 20&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; of those randomized to late tracheotomy were finally not subjected to tracheotomy&#44; due to blood gas improvement and resolution of the acute disease process that led them to require mechanical ventilation in the first place&#46; The authors underscored that the anticipation of tracheotomy increased the number of patients who were finally tracheotomized&#46; In the study published by Young et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> 14&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>66&#41; of the patients in the early tracheotomy group were not tracheotomized &#40;15 because of recovery&#41;&#44; while a full 55&#37; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>244&#41; of the patients in the late tracheotomy arm were not tracheotomized&#8211;fundamentally due to extubation and discharge from the Intensive Care Unit&#46; As commented by the authors&#44; this situation questions the capacity of clinicians to establish an early prediction of the duration of mechanical ventilation beyond a period of 7 days&#46; Both studies conclude that early tracheotomy should be avoided&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The results of these two large studies are in contrast to the data published in 2004 by Rumbak et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a> who in a randomized&#44; prospective analysis of a smaller patient sample &#40;120 medical critical patients&#58; 60 in each arm&#41; with screening criteria that do not allow generalization of the results&#44; found early tracheotomy &#40;performed after 48<span class="elsevierStyleHsp" style=""></span>h of ventilation&#41; to be associated to lesser mortality and VAP than tracheotomy performed beyond 14 days of ventilation&#46; Eight of the 60 patients &#40;13&#37;&#41; randomized to late tracheotomy were finally not tracheotomized due to extubation before day 14&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The last article published in relation to this controversial issue is a recent metaanalysis<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">5</span></a> including 11 randomized&#44; prospective trials&#46; The conclusions were that tracheostomy performed in the first 7 days of ventilation is associated to a shorter stay in the Intensive Care Unit&#44; though without differences in terms of in-hospital mortality&#46; Consequently&#44; there is no evidence in support of an early tracheotomy strategy&#46; Accuracy in predicting the duration of mechanical ventilation was cited as an important limitation of all the studies evaluated&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">In effect&#44; all the published comparative studies present the same limitation&#44; for which no solution is currently available&#58; the lack of a validated instrument for predicting prolonged mechanical ventilation&#46; As a result&#44; patient screening for inclusion has been based on subjective criteria&#46; This situation in turn has led to recruitment problems in some studies&#44; due to difficulties in anticipating the duration of ventilation&#44; or because of clinician reluctance to follow the randomization protocols&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">6&#44;7</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">In 2014&#44; Figueroa-Casas et al&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> published the results of a prospective study designed to evaluate the capacity to establish an early prediction of the duration of mechanical ventilation based on clinical judgment&#46; The analysis of the accuracy of clinical prediction during the first 48<span class="elsevierStyleHsp" style=""></span>h of intubation revealed a sensitivity of 40&#37; for mechanical ventilation lasting over 7 days&#44; versus 29&#37; for mechanical ventilation lasting over 14 days&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In 2007 we started a project designed to develop a predictive model capable of offering help in the clinical decision making process&#44; fundamentally as regards the timing of tracheotomy in ventilated patients&#44; and which was published in this journal in 2012&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> The study&#44; completed before the estimated sample size was reached&#44; and lacking the required statistical power&#44; was unable to meet the expectations&#46; Other studies in this same line have likewise been unable to define a model applicable to the clinical setting&#46; There is only a predictive equation validated for burn patients&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> but not applicable to other critical patients&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">In view of the current state of this topic&#44; the latest publications<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2&#8211;4</span></a> represent &#40;or should represent&#41; the end of comparative &#8220;early versus late tracheostomy&#8221; analyses&#46; Future evaluations in this same line cannot draw solid conclusions if no validated predictive instrument is available&#46; The lack of such an instrument results in methodological weaknesses that invalidate the findings of the studies&#46; Furthermore&#44; considering the poor clinical predictive capacity and the lack of a helping instrument&#44; would it be reasonable to plan new projects a priori assuming that a number of patients are very likely to undergo needless surgery&#44; with the sole justification of having been randomized to a given study arm&#63;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The time has come for a change in direction&#46; If we want to obtain a solid answer to the question of this &#8220;Point of view&#8221;&#44; we first will have to spend years of research in predictive models&#46; This is no easy task&#46; In the meantime&#44; the individualization of decisions remains the best strategy in routine clinical practice&#46;</p></span>"
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