Background: Tracheotomies are frequently performed on ventilated patients in intensive care and sometimes lead to fatal complications. In this article, we discuss the causes and frequency of death associated with open surgical tracheotomy (OST) and percutaneous dilatational tracheotomy (PDT) on the basis of a review of the pertinent literature.
Methods: We systematically searched the PubMed, EMBASE, and Cochrane Library databases and the Karlsruhe Virtual Catalog for publications (1990–2015) on tracheotomy-related deaths in adults, using the search terms “tracheotomy” and “tracheostomy.” 39 relevant dissertations were included in the analysis as well.
Results: 109 publications were included. Of the 25 056 tracheotomies described, there were 16 827 PDTs and 7934 OSTs; for 295 tracheotomies, the technique used was not stated. 352 deaths were reported, including 113 in patients treated with PDT, 49 in those treated with OST, and 190 deaths related to a tracheotomy without specification of the method used. The frequency of death among patients with OST and those treated with PDT was similar: 0.62% for OST (95% confidence interval [0.47; 0.82]) and 0.67% for PDT ([0.56; 0.81]). The most common causes of death and their frequencies, as a percentage of all tracheotomies, were hemorrhage (OST: 0.26% [0.17; 0.40], PDT: 0.26% [0.19; 0.35]), loss of airway (OST: 0.21% [0.13; 0.34], PDT: 0.20% [0.14; 0.28]), and false passage (OST: 0.11% [0.06; 0.22], PDT: 0.20% [KI 0.15; 0.29]).
Conclusion: Bias in the data cannot be excluded, as these were not epidemiologic data and the documentation was found to be incomplete. The likelihood of a fatal complication seems to be the same with both tracheotomy techniques as far as can be determined from the available evidence. Tracheotomy-related deaths can be avoided in several ways: by thorough training under the leadership of experienced physicians, by the use of the World Health Organization’s Surgical Safety Checklist regardless of where the tracheotomy is performed, and by the continuous vigilance of nursing staff.
Tracheotomies are among the most commonly performed procedures in mechanically ventilated intensive care patients; the two methods used are percutaneous dilatational tracheostomy (PDT) and open surgical tracheostomy (OST) (1). Every year, tracheotomy results in death or permanent disability of an estimated 500 patients in the United States alone (2). The aim of our review was to provide a literature analysis of the causes and incidence rates of tracheotomy-related deaths for both OST and PDT. We intended to study the more common complications of hemorrhage, false passage, and airway loss and to develop recommendations on how to prevent these events.
Search strategy and case selection
Over a period of 5 years, a systematic analysis of the literature published between 1 January 1990 and 31 December 2015 was performed in the databases PubMed, EMBASE, Cochrane Library, and Karlsruhe Virtual Catalog (KVK), using the keywords “tracheotomy” and “tracheostomy.” This review was conducted in accordance with the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses, www.prisma-statement.org). The primary literature from meta-analyses and reviews as well as 39 German dissertations were also included in the analysis. Original articles published in French, Spanish, Italian, Dutch, or Russian, which were discovered by English-language summaries, were translated and included. Pediatric patients were excluded from the analysis. Independent plausibility checks were performed on each death from the perspectives of otorhinolaryngology (ENT) and anesthesiology/intensive care medicine (eFigure 1).
Information about age, sex, primary disease, indication for tracheotomy, tracheotomy technique (OST, PDT) and site of performance (intensive care unit, operating room, regular ward), time (perioperative [day of surgery] or postoperative [first postoperative day and following days]), complications, and causes of death was recorded, where available. Free-text descriptions of the deaths were collected. Forty cases with unclear causes of death from 19 publications were excluded (e1–e21) (eFigure 1, eBox 1).
Descriptive analyses were performed using Microsoft Excel 2013. The results are reported as absolute values and percentages. All confidence intervals (CI) are stated at the 95% confidence level.
Our search strategy identified 109 publications (eTable 1) (e22–e119). We found 71 different free-text descriptions of tracheotomy-related deaths (eTable 2) (e22–e119) in 40 case studies (37%), 35 case reports (32%), 12 dissertations (11%), 12 case–control studies (11%), 6 randomized controlled trials (RCTs) (5%), 3 structured questionnaires (3%), and 1 review with additional own cases (1%). In 12 of 39 dissertations with a total of 4765 OSTs and 4437 PDTs, 13 patients died. The 109 publications comprised 25 056 tracheotomies, including 16 827 PDTs, 7934 OSTs, and 295 tracheotomies without information about the technique used. Altogether, 352 tracheotomy-related deaths were documented in 21 countries, thereof 113 along with PDT, 49 along with OST, and 190 without information about the technique used (Tables 1 and 2, eFigures 1 and 2).
Altogether, 65 fatal hemorrhages were reported (Table 3), thereof 38 (58.5%) brachiocephalic trunk hemorrhages where death occurred in 3 cases during the perioperative period (e15, e66, e98) and in 28 cases between day 1 and day 117 (e64), with a mean of 24 days. In 7 cases, no information about the time of death was provided (eBox 2).
False passage–related complications
In 32 patients, 44 serious complications resulted from false passage, thereof 35 along with PDTs and 9 along with OSTs (Table 4, eBox 2).
Loss of airway
Twenty-seven authors reported loss of airway of mixed etiology as cause of death; 33 cases during or after PDT and 17 during or after OST. In 7 cases, no information about the tracheotomy technique and the pathomechanisms was provided (Table 5, eBox 2).
Worldwide, tracheotomies are commonly performed procedures. In Germany, a total of 37 793 temporary tracheostomies and 16 733 permanent tracheostomies were performed in 2015 (e120).
PDT has been promoted as a quick and easy procedure in numerous publications, but warnings have also been issued (3). Tracheotomy-related deaths are described as rare events of diverse etiology (4–8, e101). Das et al. (2) reported results of a US-survey identifying an estimated 1000 serious incidents and events annually related to tracheotomies and 500 incidents resulting in death or permanent disability. It is challenging to identify special types of deaths in the literature because the search term “death” is almost always related to the outcome of studies. After analysis of data from a US database of more than 113 653 tracheotomies, Shah et al. concluded in 2012 that it is impossible to determine from these data whether the mortality is due to tracheotomy complications (9).
We started our analysis of fatal complications in 1990 because from that time PDT, as described by Ciaglia (10), has gained worldwide acceptance. The analysis of 71 free-text descriptions identified 4 key areas (eTable 2):
Tracheal hemorrhage can be life-threatening, even if the actual blood loss is low. With flexible bronchoscopy, even small amounts of blood can significantly reduce visibility in the surgical field. In addition, the suction capacity of flexible endoscopes is lower than that of rigid endoscopes. This concerns the amount of blood and the time factor and is of vital importance especially in patients with respiratory failure. Due to the dead space in the airways, intratracheal hemorrhage of 150–200 mL results in hypoxia, long before circulation is affected. Taking this into consideration, the discussion in the literature about “major bleeding” or “minor bleeding,” with various amounts suggested to define clinically relevant hemorrhages, appears pointless, as demonstrated by the following 4 examples: 50 mL (e115), more than 100 mL (e10), more than 5 ccm (11), “major bleeding: surgical intervention or transfusion” (12). Apart from bleeding associated with tracheo-innominate fistula (TIF), not the defined amount of blood lost is important, but the question to where the blood flows. While relevant external bleeding requires primary revision surgery, internal bleeding should trigger the algorithm to immediately secure the airway. Here, monitoring gas exchange is critical and determines the time window for the steps to be taken. Tracheotomy-related deaths reported in the literature remind us of the importance of these considerations which should, of course, go without saying. Likewise, changing from flexible endoscopy to rigid endoscopy is part of the emergency treatment, if indicated.
Intraoperative hemorrhages resulting in death (Table 3) occur typically with PDT, including cases of false passage with fatal bleeding. Ayoub et al. (e23) described deaths resulting from variations in vascular anatomy and highlighted the need to constantly be aware of this possibility. This is underscored by 9 cases with fatal outcome reported in the literature. Preoperative ultrasonography of the neck with visualization of the large blood vessels, the thyroid and the course of the trachea as part of a preoperative checklist is recommended (13).
Postoperative hemorrhages after tracheotomies can be life-threatening, as the neck region is rich in blood vessels. Halum et al. (e58) analyzed postoperative hemorrhages, the most common complication, up to the first week after tracheotomy. Later bleeding events may disappear from the sight of intensivists and shift via the path of rehabilitation facilities to the nursing domain. In our review, higher rates of postoperative hemorrhages occurred with OST compared to PDT, in terms of the total number of fatal complications with each technique—PDT versus OST (Table 1). Kearny et al. (e72) found postoperative hemorrhage to be the most common complication with 2.2%.
Brachiocephalic trunk hemorrhage—tracheo-innominate fistula
Performing tracheotomies below the level of the 4th tracheal ring is dangerous because of the vascular anatomy in this area. Thus, it is critical to accurately establish the patient’s external and internal anatomy by means of preoperative examination, ultrasonography and endoscopy of the trachea. Tracheo-innominate fistula (TIF) has been regarded as a rare, but often fatal complication for many years (e34). In case of severe hemorrhage, rigid tracheobronchoscopy is the method of choice, as it offers better visibility and significantly greater suction capacity for blood in a short period of time (e121). In addition, endotracheal intubation with targeted tamponade of the bleeding source with the tube’s cuff can be performed at any time via a rigid endoscope (7) (Table 3).
A false passage may have fatal consequences, regardless of the type of tracheotomy. Tracheotomies below the level of the 4th tracheal ring may be fatal. In 13 cases, it caused a TIF with fatal hemorrhage. These bleeding events occurred more frequently with PDT, performed with and without flexible endoscopy, indicating that PDT with endoscopy does not provide adequate orientation. Furthermore, 10 fatal cases of pneumothorax and 5 cases of tracheoesophageal fistula (TEF) occurred with PDT with and without flexible endoscopy. Not every false passage leads to a fatal outcome. Van Heuern et al. (e60) reported that primarily false passage is to be expected in 0.5 to 2% of cases treated with PDT. Marx et al. (e84) reported false passages in 1.2% and Kearny et al. (e72) in 0.7% of cases treated with endoscopically controlled PDT. According to our analysis of complications, false passage–related fatal outcomes are to be expected in 0.20% of cases with PDT and in 0.11% of cases with OST. Even though these incidences may appear low, they represent 25 deaths which could have been prevented, as demonstrated by the retrospective analysis. After OST, 7 patients had false passage–related fatal outcomes. With intensive care medicine being such a sensitive field, there appears to be even more reason to categorize PDT as a high-risk procedure (e100). The term high risk describes best the nature of complications that occasionally occur. The same applies to OST. The analysis of the cases of tracheotomy-related deaths clearly shows that tracheotomy is not a procedure to be performed by beginners. Intensive training in anatomy and the techniques of PDT and OST under the guidance of experienced ENT specialists, surgeons and intensivists is vital, given the 32 deaths identified in our review (Table 4). With flexible endoscopy not always providing the best possible orientation, rigid endoscopy with mechanical ventilation via the endoscope was introduced as an alternative PDT technique to prevent serious complications (14).
Loss of airway
Loss of airway (Table 5) is a widely feared adverse event; it can occur in 5 situations:
Incidence of tracheotomy-related deaths
The exact reasons for the differences between the incidences of tracheotomy-related deaths reported by various authors are unknown; possible factors include differences in scope as well as small patient samples (17) and reference to procedures performed many years ago when other surgical techniques were used (18) (Table 5). Compared with other papers, our review is based on the largest number of deaths and the largest number of tracheotomies performed. Consequently, it is difficult to precisely state the incidence of tracheotomy-related deaths. In our analysis presented here, the death rate is 1.4% (352 deaths on 25 056 tracheotomies). However, it is very likely that this rate may be over- or underestimated; thus, it should not be considered as being representative of the true rate. Death statistics report similar rates for PDT and OST; however, one limitation is that for 190 deaths no information on the technique used for tracheotomy was available, besides the lack of epidemiological data. Our review did not confirm the reported finding of higher operative mortality with OST compared to PDT (3% versus 0%) (19). This finding was flawed because for PDT references from the current literature were selected, while for OST references from the literature published between 1969 and 1981 were used which do not reflect today’s OST techniques and generally improved safety standards. Likewise, the assumption that the majority of meta-analyses demonstrate reduced procedure-related mortality for PDT (20) is not tenable, as it conveys a false sense of security for PDT. The mortality rates we found for PDT (0.67%; 95% CI [0.56; 0.81]) und OST (0.62% [0.47; 0.82]) are based on the total number of 16 827 PDTs and 7934 OSTs. From the perspective of medical law, it should be noted that, according to the currently available data, the risk of tracheotomy-related death appears to be the same for both techniques as they are practiced today.
Our review found numerous documentation shortcomings. We identified 190 tracheotomy-related deaths where no information about the method of tracheotomy used had been recorded. Time-of-death data were missing in 196 cases, while information about the place of tracheotomy and the place of death (intensive care unit, operating room, regular ward) was not available in 242 cases. Gender data were missing in 136 cases, while in 216 cases information about gender was reported (125 men, 91 women). The primary disease was documented in 203 deaths, but was missing in 149 deaths. In 40 cases, autopsy results were reported as part of quality assurance protocols and in 7 cases autopsy was refused. In 305 deaths, no information about whether an autopsy had been performed was available. The true number of tracheotomy-related deaths is difficult to determine. It is reasonable to assume that some fatal outcomes remain unreported. Publication bias is obviously an issue as not every death is published in the literature. Numerous tracheotomy-related studies, addressing a broad range of questions, have been conducted, but complications were not documented; thus, a number of deaths may remain unrecognized. Additional unreported cases may occur when in studies tracheotomy-related deaths are included under “deaths and survivals” without further comment. Brass et al. (8) confirmed that numerous studies are flawed by shortcomings and inaccuracies, resulting in a low level of evidence for certain aspects of tracheotomy-related mortality.
From the perspective of medical law, it should be noted that, according to the currently available data, the risk of tracheotomy-related death appears to be the same for both techniques as they are practiced today. Performing tracheotomies below the level of the 4th tracheal ring is dangerous due to the vascular anatomy in this area. It is recommended to use rigid tracheobronchoscopy in cases of severe hemorrhage because of the good visibility and high suction capacity for blood offered by this method. Rigid endoscopy should be available whenever surgical procedures involving the trachea, including PDT, are performed. Tracheotomies should not be performed by inexperienced surgeons. Extensive knowledge of the anatomy and the techniques of PDT and OST is crucial, as is training by experienced ENT surgeons, general surgeons, and intensivists. To improve tracheotomy quality management and care and to prevent fatal complications, tracheotomy-related deaths should be given more attention in the future, e.g. by publishing case reports (21). Given the successful reduction of perioperative mortality and positive experiences with interdisciplinary communication prior to surgical procedure, it appears advisable to recommend the use the WHO’s Surgical Safety Checklist for tracheotomies as well, regardless of the place where they are performed (13).
We would like to extend our thanks to the physicians Dr. Ulrike Mattarei, Dr. Andreas Deutscher and Günther Gehrka for translating references relevant to our review and to the staff of the Scientific Library of the Muncipial Hospital Dresden for their support.
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript received on 2 September 2016; revised version accepted on 9 February 2017
Translated from the original German by Ralf Thoene, MD.
Dr. med. Andreas Karl Nowak
Klinik für Anästhesiologie und Intensivmedizin, Notfallmedizin und Schmerztherapie, Städtisches Klinikum Dresden
01067 Dresden, Germany
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