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- W1969115204 abstract "Abbreviations and Definitions: Tracheotomy is a hole that is placed into the trachea. Tracheostomy is a surgically constructed artificial opening (stoma) for external fistulization. Percutaneous tracheotomy is a tracheal tube placed through the skin into the trachea. The cartilage rings of the trachea are dilated and separated and not cut through as an open tracheotomy. The so-called percutaneous dilatational tracheotomy (PDT). Ventilator-associated pneumonia (VAP). Intensive care unit (ICU). Acute Physiology and Chronic Health Evaluation II (APACHE II). Acute Respiratory Distress Syndrome (ARDS). Partial pressure of oxygen in the arterial blood divided by the fraction of inspired oxygen (PaO2/FiO2). Glasgow coma score (GCS). Simplified Acute Physiology Score (SAPS) II. Percutaneous endoscopic gastroscopy (PEG). Center for Disease Control (CDC) Tracheotomy is a common surgical procedure in critically ill patients who require prolonged mechanical ventilation. The definition of prolonged mechanical ventilation has until recently been variably defined. Recent consensus statements define prolonged mechanical ventilation as the need for ≥21 consecutive days of mechanical ventilation for ≥6 hours per day.1 The role of tracheotomy for patients requiring prolonged mechanical ventilation has been an area of controversy. In the early 1960s early tracheotomy was favored over translaryngeal intubation.1–3 However, improved endotracheal tubes and ventilatory equipment coupled with technical and procedure-related complications related to tracheotomy resulted in delay of tracheotomy in favor of prolonged translaryngeal intubation.1–3 In 1989, Plummer and Gracey4 published the Consensus on Artificial Airways in Patients Receiving Mechanical Ventilation which provided recommendations for the placement of translaryngeal endotracheal tubes and tracheotomy. In regard to tracheotomy, the following guidelines were recommended: “(1) For anticipated need of the artificial airway up to 10 days, the translaryngeal route is preferred. (2) For anticipated need of the artificial airway for greater than 21 days, tracheotomy is preferred. (3) When the time anticipated for maintenance of an artificial airway is not clear, daily assessment is required to determine whether conversion to tracheotomy is indicated. (4) The decision to convert to tracheotomy should be made as early as possible in the course of management to minimize the duration of translaryngeal intubation. Once the decision is made, the procedure should be performed without undue delay, except in circumstances such as life-threatening cardiopulmonary instability, uncorrected coagulopathy, or other mitigating circumstances.”4 Several studies have investigated the validity of recommending early tracheotomy for critically ill patients who are anticipated to require prolonged mechanical ventilatory support. Tracheotomy offers appealing advantages over prolonged translaryngeal intubation which has been associated with injury to the mouth, larynx, and trachea as well as dangers of self-extubation and malposition, parasinusitis, physical discomfort, and need for increased sedation.5–7 A tracheotomy circumvents many of these disadvantages and provides clinically relevant benefits including a well-tolerated, stable airway requiring minimal if any sedation, the potential for oral feedings and enhanced communication, improved pulmonary mechanics, patient comfort, permits early ambulation, and facilitates pulmonary toilet and oral hygiene.8–11 However, complications associated with the procedure are well described and include stomal infection, tracheomalacia and granulation tissue, tracheal stenosis, injury to great vessels of the neck, pneumothorax, subcutaneous emphysema, esophageal injury, damage to the posterior tracheal wall, and in a small percentage (<1%) death.8,12,13 The role of tracheotomy in patients requiring mechanical ventilation has been facilitated by the development of percutaneous tracheotomy techniques. Percutaneous dilational tracheotomy (PDT) has gained increasing popularity among critical care physicians as a means of airway management in patients requiring prolonged mechanical ventilatory support. Ciaglia et al14 first described the current technique, in 1985. The expanding role of tracheotomy most likely stems from the fact that critical care physicians without formal surgical training can perform this procedure easily and safely using a variety of commercially available kits.15,16 Despite the associated complications, studies have shown that PDT is a safe procedure associated with low complication rates which are similar to those of standard surgical techniques (estimated morbidity of 4%).11,12,15,16 Advantages of the PDT over standard surgical tracheotomy include simplicity of procedure, shortened time to complete, cost, and convenience of performing the procedure at bedside rather than tying up busy surgical suites.15 Despite consensus statements, the exact timing and clinical benefit of tracheotomy remain controversial.12,17–19 Several studies have investigated the effect of early versus delayed tracheotomy as related to clinical outcomes in patients requiring prolonged mechanical ventilation. The study designs have varied greatly and include randomized prospective controlled, prospective nonrandomized, observational, and retrospective studies. This paper reviews the clinical benefits of tracheotomy as related to timing of the procedure. To facilitate the analysis of this literature, we have chosen to review effect of tracheotomy timing on mortality, ventilator-associated pneumonia (VAP), days on mechanical ventilation, length of intensive care unit (ICU) or hospital stay, hospital cost and long-term outcomes, and other clinical benefits of tracheotomy. Studies will be reviewed in the order of randomized controlled, prospective nonrandomized, and retrospective studies. Further, the studies showing benefit of tracheotomy will be reviewed first followed by negative or equivocal studies. The review will not make distinctions between surgical versus percutaneous tracheotomy as available data suggest similar morbidity and mortality between the 2 procedures. MORTALITY This section will review the benefit of tracheotomy as related to mortality. Specific focus points will be study design, study patient populations, and timing of tracheotomy. Rumbak et al20 designed a prospective, multi-institutional, randomized controlled study to evaluate the benefits of early tracheotomy (within the first 2 d) versus late tracheotomy (days 14 to 16) in the critically ill medical patients (Table 1). This study noted a statistically significant reduction in mortality with early tracheotomy 31.7% (19/60) versus 61.7% (37/60), respectively. Review of the baseline patient characteristics showed no statistical difference between the 2 study populations with average Acute Physiology and Chronic Health Evaluation II (APACHE II) scores of 27.4 and 26.3, respectively, and an average age of 63 years. In regard to cause of death more patients died of VAP in the prolonged translaryngeal group than in the early tracheotomy group. The authors note in the discussion that patients randomized to delayed tracheotomy had a higher than predicted (based on APACHE II score) mortality rate (61.7% vs. predicted 50%). The authors suggest that patient factors including lactic acidosis, number of organ failures, or high-dose vasopressors accounted for the higher mortality rate than the APACHE II score would predict.TABLE 1: Prospective, Randomized, Controlled Studies Comparing Early Versus Delayed Tracheotomy in the Management of Patients Requiring Prolonged Mechanical VentilationBarquist et al,21 conducted a prospective, single institution, randomized controlled trial to evaluate the benefits of early tracheotomy (Table 1). The study population included trauma patients requiring mechanical ventilation. Tracheotomy was considered early if performed before day 8 and late after 28 days of mechanical ventilatory support. Patient demographics were not statistically different. Average APACHE II scores of the 2 study populations were 12.1 and 13.1, respectively. No statistically significant mortality difference was noted with overall mortality 6.89% (2/29) and 16.1% (5/31), respectively. The lack of mortality benefit may reflect the underlying clinical features (ie, lower APACHE II, surgical trauma patients) of this study population or may be related to the longer duration of translaryngeal intubation before undergoing tracheotomy. Bouderka et al22 conducted a prospective, single institution, randomized controlled study to evaluate the benefits of tracheotomy in severe head injured patients. In this study early tracheotomy was performed on day 5 or day 6 postintubation and patients not randomized to tracheotomy were maintained via translaryngeal intubation (Table 1). Simplified Acute Physiological Scores (SAPS II) were similar between the 2 study populations (5.4 and 6, respectively). No mortality benefit was noted with tracheotomy 38.7% (12/31) and 22.5% (7/31), respectively. The lack of mortality benefit may reflect the underlying clinical features of this study population. Interestingly, the authors reported cause of death for each study arm. Cause of death in patients randomized to tracheotomy was intracranial hypertension 4/12, sepsis 1/12, Acute Respiratory Distress Syndrome (ARDS) 7/12, and cardiovascular dysfunction 0/12. Cause of death in patients randomized to prolonged translaryngeal intubation was intracranial hypertension 1/12, sepsis 3/12, ARDS 2/12, and cardiovascular dysfunction 1/12. Saffle et al,23 conducted a prospective, single institution, randomized controlled study to evaluate the benefit of early versus delayed tracheotomy in intubated and acutely burned patients (Table 1). Early tracheotomy was performed at a mean 4 days postburn and late tracheotomy at day 14 or more postburn. No mortality benefit was noted between the 2 study arms 19% (4/21) versus 26% (6/23), respectively. One key aspect of the study was the finding that patients in the early tracheotomy group had statistically significant higher full thickness burns, statistically significant higher prediction scores in regard to anticipated need for prolonged mechanical ventilation, and statistically significant lower partial pressure of oxygen in the arterial blood divided by the fraction of inspired oxygen (PaO2/FiO2) ratios than those patients in the late tracheotomy group. These clinical variables may have obscured any mortality benefit associated with early tracheotomy. Sugerman et al24 designed a prospective, multi-institutional randomized controlled study to evaluate the benefits of early tracheotomy in patients with head trauma, nonhead trauma, and critically ill nontrauma patients (Table 1). In this study, early tracheotomy was performed between days 3 and 5, intermediate tracheotomy between days 10 and 14, and late tracheotomy on or after day 21 of mechanical ventilation. Only the nonhead trauma and nontrauma study arms employed randomization between intermediate and late tracheotomy. No benefit in regard to mortality was noted with early tracheotomy in any of the study populations 24% (13/53) versus 19% (11/59), respectively. The mortality within each study arm was as follows: head trauma 14% (5/35) versus 3% (1/32); nonhead trauma 46% (6/13) versus 35% (7/20); and nontrauma 40% (2/5) versus 42% (3/7). The mortality data could have been influenced by the fact that the APACHE III score was statistically higher in the patients randomized to early tracheotomy in the head trauma (65 vs. 51), and nontrauma (92 vs. 68) study arms. The nonhead trauma study arm patients randomized to early tracheotomy had statistically lower Glasgow Coma Scores (GCSs) (10 vs. 13). Similarly, no benefit of tracheotomy was noted when intermediate versus late tracheotomy study populations were compared. In this later arm of the study, no statistically significant differences were noted between the patient characteristics of the 2 study arms. Additional, confounding variables of this study included incomplete data collection or no data submission from some participating hospitals and loss of patients to follow-up. Rodriguez et al11 also conducted a prospective, single institution, randomized controlled trial to evaluate the benefits of early tracheotomy in patients admitted to the surgical ICU (Table 1). The study population encompassed patients admitted to the surgical ICU with multiple injuries who required mechanical ventilation. Patient demographics, injury type, and surgical interventions were similar between the 2 study populations. Average age was 36 and 39 years, respectively. The average APACHE II score, Injury Severity Score, and GCSs were 10, 28, 10 and 10, 27, 10, respectively. Early tracheotomy in this patient population ranged up to 7 days (average 4 d) and late tracheotomy occurred after 8 days of mechanical ventilation (average 11 d). No statistical significance difference was noted in overall mortality between the 2 study populations 18% (9/51) versus 23% (13/56), respectively. The lack of mortality benefit may reflect the underlying clinical features of this study population. Another possibility may relate to the longer duration of translaryngeal intubation before undergoing tracheotomy. Only 12/51 patients in the early tracheotomy arm underwent the procedure within the first 2 days. Interestingly, Rodriguez et al, did note a decreased incidence of pneumonia within the early tracheotomy arm 78% versus 96%, respectively, however, this did not translate to improved survival. An important observation is that the most significant reduction in pneumonia incidence occurred in those patients undergoing tracheotomy within the first 2 days, no mortality data are reported for this small subset patient population. Chintamani et al26 conducted a prospective, single institution, nonrandomized study evaluating the benefits of tracheotomy in closed head injured patients (Table 2). The study population consisted of patients with closed head injury and GCS less than 8 and SAPS II score greater than 50. Polytrauma patients or other injury besides closed head injury were excluded. In this study, tracheotomy was performed on an average 2.18 days of hospitalization. The control group constituted patients with similar injury but not undergoing tracheotomy during the hospitalization. Mortality in the early tracheotomy group was 36% (18/50) compared with 58% (29/50) in the nontracheotomy group. This finding correlated with improved GCS scores at day 15 and lower SAPS II scores at days 10 and 15 indicating clinical improvement in patients undergoing tracheotomy. The design of this study may have skewed data by selection bias of patients with better prognosis to early tracheotomy.TABLE 2: Prospective Nonrandomized Studies Comparing Early Versus Delayed Tracheotomy in the Management of Patients Requiring Prolonged Mechanical VentilationBoynton et al27 conducted a prospective, single institution, nonrandomized study to evaluate clinical impact of tracheotomy timing in surgery or trauma ICU patients (Table 2). Demographics were notable for greater number of traumatic brain injury patients and multiple trauma victims in the early tracheotomy group, however, the median GCS for both groups was 11. Median timing of early tracheotomy was 6 days as compared with 14 days for the late tracheotomy group. This did not detect any statistically significant difference in mortality between the 2 study arms 0% (0/21) and 9% (5/53), respectively. It should be noted that there were no deaths in the early tracheotomy group. The design of this study may have skewed data by selection bias of patients with better prognosis to early tracheotomy and overall low mortality in both study arms. Arabi et al28 conducted a prospective, single institution, nonrandomized study on the clinical impact of early (up to 7 d) as compared with late tracheotomy (after 7 d) in trauma patients admitted to the ICU who required tracheotomy during their ICU stay (Table 2). No benefit as related to ICU mortality 3% (1/29) versus 1% (1/107) or hospital mortality 17% (5/29) versus 14% (15/107) was noted in this study. Although the APACHE II score and Injury Severity Scores were similar for the 2 study populations (20 vs. 19 and 33 vs. 34, respectively), the GCS was statistically significantly lower in the patients selected for early tracheotomy (5.2 vs. 6.5, respectively). Further, the early tracheotomy group of patients was noted to have statistically fewer attempts at weaning from mechanical ventilation. These findings suggest that more critically injured patients may have been selected for early tracheotomy or may reflect differences in injury pattern (more patients in the early tracheotomy group had maxillofacial injuries) and differences in the clinical management of such patients. El-Naggar et al,2 conducted a prospective, single center, nonrandomized study to evaluate the benefits of early tracheotomy (Table 2). Early tracheotomy was performed on day 3 and late tracheotomy after 10 or 11 days of mechanical ventilation. Patients admitted to the ICU with acute respiratory failure requiring mechanical ventilation comprised the study population. Patient characteristics and demographics were not statistically different between the 2 study populations. No mortality benefit was noted with early tracheotomy. Blot et al,29 conducted a retrospective review to evaluate the benefits of early tracheotomy in neutropenic mechanically ventilated patients. Tracheotomy was considered early if performed within 48 hours of mechanical ventilatory support and late if performed after this time period (Table 3).29 The patient characteristics were notable for more profound neutropenia in the early tracheotomy group. ICU and in hospital mortality was not statistically different 70% (14/20) versus 78.8% (26/33) and 75% (15/20) versus 81.8% (27/33), respectively. However, survival curves did show a trend toward longer ICU survival with early tracheotomy and the trend appeared significant after adjusting for the degree of neutropenia.TABLE 3: Retrospective Studies Comparing Early Versus Delayed Tracheotomy in the Management of Patients Requiring Prolonged Mechanical VentilationArmstrong et al30 retrospectively evaluated the benefits of tracheotomy in ventilated patients. The study population included patients with blunt trauma undergoing tracheotomy during hospitalization. Tracheotomy was considered early if performed within the first 6 days and late on day 7 or later of mechanical ventilation (Table 3). No benefit with regard to mortality was noted in the early tracheotomy group 11.8% (7/62) versus 11.6% (11/95), respectively. Kluger et al31 conducted a retrospective study to evaluate the benefits of early tracheotomy in trauma patients. Three study populations were analyzed: early tracheotomy (within 0 to 3 d), intermediate tracheotomy (within 4 to 7 d), and late tracheotomy (after 7 d) (Table 3). No statistical significance in mortality was noted; however, only 14 (12%) of the patients died after 7 days of hospitalization. None of these deaths occurred in the early tracheotomy group. Interestingly, this study did note a statistically significant lower incidence of pneumonia with early tracheotomy; however, this did not translate to reduced mortality. In reviewing the data, the early tracheotomy group did have lower mean GCS as compared with the intermediate and late tracheotomy group (7.1 vs. 9.6 vs. 11, respectively). Thus, the early tracheotomy study population may have been comprised of more severely injured patients. The low mortality may have also obscured mortality benefit. It remains unclear if this difference affected the study findings as related to mortality. D'Amelio et al,32 conducted a retrospective review to evaluate the benefits of early tracheotomy and percutaneous endoscopic gastroscopy (PEG) in the management of head-injured patients. Trauma patients undergoing these procedures constituted the study population (Table 3). Tracheotomy and PEG placement was considered early if performed within the first 7 days and late after 7 days of mechanical ventilatory support. The patient demographics were not statistically different with an average GCS of 6.6 and 7.2, respectively, and APACHE II score of 14.3 and 14.6, respectively. No mortality benefit was noted 9.5% (2/21) versus 10% (1/10), respectively. The low mortality and sample size may have impacted the study results. Combes et al,34 conducted a retrospective review to evaluate the benefit of tracheotomy in patients requiring long-term mechanical ventilatory support. The data analyzed were from a single institution. Study population included mechanically ventilated patients who underwent tracheotomy after at least 3 days of mechanical ventilation. The outcome was compared with patients not undergoing tracheotomy but with similar matched clinical characteristics (Table 4). Patients underwent tracheotomy after a median of 12 days of mechanical ventilation. Tracheotomy was associated with improved ICU and Hospital mortality 33% (55/166) versus 56% (142/340) and 37% (62/166) versus 48% (163/340), respectively. Interestingly, the survival of patients undergoing tracheotomy within 10 days was 75% versus a 66% survival if performed after 10 days suggesting that early tracheotomy favored survival.TABLE 4: Studies Comparing Tracheotomy to Prolonged Translaryngeal Intubation in the Management of Patients Requiring Prolonged Mechanical VentilationFreeman et al,35 conducted a retrospective review to evaluate the benefits of tracheotomy in regard to timing and duration of mechanical ventilation in critically ill patients. The study population included 43,916 patients with respiratory failure who required mechanical ventilation (Table 4). Comparison of mortality was conducted between those patients who did and did not undergo tracheotomy. In this study, median days of mechanical ventilation before patients underwent tracheotomy were 9 days. Data analysis showed tracheotomy was associated with improved ICU and hospital survival 87.6% (2167/2473) versus 74.6% (30,741/41,217) and 78.1% (1931/2473) versus 71.7% (29,954/41,217), respectively. Statistically significant variables in the clinical characteristics of the 2 study populations were noted which may have influenced the results of this study. Frutos-Vivar et al,36 conducted a prospective, multicenter, nonrandomized study evaluating the outcome of mechanically ventilated patients requiring tracheotomy. The study population consisted data from adult patients who required mechanical ventilation (Table 4). The baseline clinical characteristics were diverse. The median time of tracheotomy was day 12. This study compared outcomes and clinical features of patients who underwent tracheotomy with those not undergoing tracheotomy. In this study, tracheotomy was associated with a mortality benefit in the ICU 20% versus 32% but not overall hospital mortality, which was similar in both study populations 39% versus 40%. Kollef et al37 conducted a prospective, single center, nonrandomized study to evaluate clinical predictors and outcomes for patients requiring tracheotomy. The study population consisted of all patients receiving mechanical ventilation for greater than 12 hours. Outcomes were compared with those patients who required mechanical ventilation but did not undergo tracheotomy (Table 4). Mean duration of mechanical ventilation before tracheotomy was 9.7 days. The hospital mortality of patients with tracheotomy was 13.7% (7/51) versus 26.4% (124/470) for patients not undergoing tracheotomy. Further hospital survivors receiving a tracheotomy had significantly higher APACHE II scores than hospital survivors who did not receive a tracheotomy (18.8 vs. 15.7). Interestingly, the improved hospital mortality in patients undergoing tracheotomy was only statistically significant among medical patients. No significant difference in hospital mortality was observed between the surgical patients with and without tracheotomy. In summary these 4 latter studies consisted of a diverse study populations, were nonrandomized design, and the design of the studies were to elicit differences in clinical outcomes between patients who undergo tracheotomy as compared with continued translaryngeal intubation. The particular design of these types of studies may skew data to show improved survival to patients undergoing tracheotomy by simple selection bias of patients for tracheotomy to those expected to survive hospitalization. The study by Combes et al,34 was interesting in that they did not detect any statistical difference between the 2 patient populations based on day-3 clinical characteristics. However, the median day for patients undergoing tracheotomy was after 12 days of mechanical ventilation. No comparison of the clinical characteristics of the 2-study populations was reported for this time interval. The studies evaluating early versus delayed tracheotomy yield mixed results as related to mortality benefit with early tracheotomy. As one analyzes these studies several factors become clear. First, early tracheotomy is an arbitrary definition and not standardized in the various studies reported in the literature. This variable alone makes comparisons of various studies difficult. Second, there is a diverse and distinct difference in the various patient populations that comprise each study population. The reasons for patients requiring prolonged mechanical ventilation as related to head injury are likely to be very different than those variables for patients in the medical ICU. Third, the severity of illness in the respective studies evaluating early versus delayed tracheotomy is diverse making the generalization of study findings for a focused patient population difficult. Finally, the definition of mortality benefit is variable with some studies reporting both ICU and hospital mortality data whereas other reporting only a single variable. The benefit of tracheotomy as related to mobilization from the ICU to a step down or intermediate care setting in the patient requiring prolonged mechanical ventilation may skew data favoring early tracheotomy if only ICU mortality is considered. Despite the above confounding variables review of the various studies yields several interesting observations. First with the exception of the early study by El-Naggar, none of the studies showed any significant harm as related to early tracheotomy. One could speculate that improved technical and mechanical aspects as related to tracheotomy may explain the discrepancies between the study by El-Naggar and the more recent studies. Second, the studies that showed favorable outcomes with mortality were those studies, which employed the earliest time frame for tracheotomy. Third, even when considering the randomized, controlled studies, many of the studies had statistically significant differences in the patient characteristics with bias of early tracheotomy arms toward sicker or more severely injured patients. Finally, the available data suggest that there may be differences as related to early tracheotomy mortality between various patient populations. This finding was noted in the study by Kollef et al,37 who demonstrated that hospital mortality was only statistically different among medical intensive care patients. Indeed the only randomized controlled study which showed benefit with early tracheotomy was that by Rumbak et al,20 for which the study patient population encompassed medical ICU patients. In this study, mortality seemed to correlate with decreased incidence of ventilator-associated pneumonia.20 The study by Rodriguez et al,11 noted decreased incidence of pneumonia with early tracheotomy, however, no benefit with respect to overall mortality was noted. This later study population encompassed patients in the surgical critical care setting.11 Barquist et al,21 noted neither benefit of mortality or pneumonia as related to early tracheotomy in ventilator-dependent trauma patients. The major difference between the latter 2 studies related to the timing of tracheotomy.11,21 Benefits of early tracheotomy as related to mortality await additional randomized controlled studies. These studies should focus on evaluating specific subsets of ICU patients, employ tracheotomy within 48 hours for early study arms, enroll the more critically ill patients to allow smaller study population to power the study for evaluation of mortality (ie, prevent type II error), and report both ICU and hospital survival data. VAP VAP is a serious hospital-acquired infection among patients requiring mechanical ventilation.38,39 It is estimated that VAP complicates up to 28% of patients requiring mechanical ventilation with an estimated increase of over $40,000 in mean hospital charges as related caring for afflicted patients.38,39 The studies analyzing mortality attributed to VAP have noted increased risk of death of up to 33%.38,39 The timing of tracheotomy in critically ill patients as related to incidence of pneumonia remains an important issue. The pathogenesis of VAP is thought to be as follows: with translaryngeal intubation, pooled secretions above the endotracheal cuff are aspirated from the oropharynx through the vocal cords kept open by the endotracheal tube. The secretions are then aspirated into the distal airway and moved into the inner part of the endotracheal tube where a biofilm develops and becomes infected. Tracheotomy allows the vocal cords to remain closed and the inner cannula of the tracheotomy tube can be easily changed to prevent development of biofilm buildup.40,41 This section will specifically review studies evaluating the prevalence of VAP in early tracheotomy compared with prolon" @default.
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- W1969115204 title "The Timing of Tracheotomy in Patients Requiring Prolonged Mechanical Ventilation" @default.
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