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(Chest. 2003;123:151-158.)
© 2003 American College of Chest Physicians

Complications of Tracheostomy Performed in the ICU*

Subthyroid Tracheostomy vs Surgical Cricothyroidotomy

Bruno François, MD; Marc Clavel, MD; Arnaud Desachy, MD; Stéphane Puyraud, MD; Jérôme Roustan, MD and Philippe Vignon, MD PhD

* From the Intensive Care Unit (Drs. François, Clavel, Desachy, Roustan, and Vignon) and the Ear Nose Throat Department (Dr. Puyraud), Dupuytren Teaching Hospital, Limoges, France.

Correspondence to: Bruno François, MD, Service de Réanimation Polyvalente, CHU Dupuytren, 2 Av Martin Luther King, 87042 Limoges Cedex, France; e-mail: realim{at}unilim.fr


    Abstract
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Background: The morbidity of surgical tracheostomy performed in critically ill patients is not well-known. Accordingly, the aim of this prospective study was to determine the incidence and severity of complications associated with subthyroid tracheostomy and cricothyroidotomy when performed in the ICU.

Methods: Over a 2-year period, individual consecutive patients who were undergoing an elective tracheostomy were studied. Attending physicians elected the timing and technique of the tracheostomy. All procedures were performed at the bedside. A complete laryngeal examination was performed before ICU discharge, prior to decannulation, and 6 months after the tracheostomy.

Results: A tracheostomy (subthyroid, 86 patients; cricothyroidotomy, 32 patients) was performed in 118 of 1,574 patients (mean [± SD] age, 54 ± 18 years; 79 men, 39 women; mean APACHE [acute physiology and chronic health evaluation] II score, 19 ± 2). No deaths could be attributed to the tracheostomy procedure, and 40 complications occurred in 36 patients (30%), with a similar incidence in both groups (subthyroid group, 30 of 86 patients; cricothyroidotomy, 10 of 32 patients; p = 0.9). The severity and timing of complications were comparable between groups.

Conclusions: In the present series, the incidence and severity of complications associated with conventional subthyroid tracheostomy and surgical cricothyroidotomy performed in the ICU were similar. The bedside cricothyroidotomy, which is technically easier to perform, represents a valuable alternative to conventional tracheostomy in the management of critically ill patients.

Key Words: intensive care • postoperative complications • tracheostomy


    Introduction
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Although surgical tracheostomy has become a procedure that is commonly performed in critically ill patients,1 the morbidity of the different surgical techniques currently used in ICUs is not well-known. Previous studies have reported complication rates of surgical tracheostomy ranging from 6 to 65%.2 3 4 However, with the exception of the study of Stauffer et al,3 who evaluated their patients 6 months postprocedure, only a few studies have prospectively reported on the complications attributable to tracheostomy during a predefined follow-up period. In an attempt to reduce the incidence of complications attributed to surgical tracheostomy, intensivists who are commonly involved in the management of these complications, have developed percutaneous procedures.5

Conventional surgical tracheostomy is performed through a subthyroid incision of the trachea, between the second and third tracheal rings. Cricothyroidotomy has traditionally been used as an emergency procedure, due to the initially reported high incidence of subsequent subglottic stenosis with this technique, which requires challenging surgical repair.6 7 However, in a large retrospective study including 655 patients with a 1-year follow-up, Brantigan and Grow8 demonstrated that complications related to surgical cricothyroidotomy were not more severe or more frequent than those associated with conventional subthyroid tracheostomy.

As far as we know, no prospective study has yet compared the complications attributed to both surgical techniques used for tracheostomy in critically ill patients. Accordingly, we sought to prospectively determine the incidence and severity of complications associated with conventional subthyroid tracheostomy and surgical cricothyroidotomy that are performed at the patient’s bedside in the ICU.


    Materials and Methods
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Study Population
Over a 2-year period, all patients hospitalized in the 22-bed ICU of Limoges University Hospital (France) who underwent an elective tracheostomy were studied. Exclusion criteria included the following: (1) having undergone an emergency tracheostomy and (2) a history of previous tracheostomy, neck surgery, cervical irradiation, or laryngeal disease.

In each patient, the following parameters were noted: age; sex; body mass index; APACHE (acute physiology and chronic health evaluation) II score on ICU admission; reason for admission to the ICU; length of ICU stay; indication for tracheostomy; duration of mechanical ventilation prior to tracheostomy; number of endotracheal intubations prior to tracheostomy; duration of cannulation; as well as different factors that could result in a technically challenging surgical tracheostomy, including the presence of a distorted neck anatomy or coagulopathy. The ICU morbidity and mortality at 6 months after ICU discharge also were recorded.

Patients were divided into two groups, according to the technique of tracheostomy used (subthyroid tracheostomy vs surgical cricothyroidotomy). Randomization was not performed since the technique of surgical tracheostomy was chosen by each attending physician based on anatomic or functional factors that are known to influence the feasibility of the procedure. Cricothyroidotomy was performed in the presence of at least one of the following criteria: (1) severe distortion of neck anatomy (ie, short neck, severe cervical kyphosis, and deep trachea); (2) morbid obesity (body mass index, > 40); or (3) patients with poor prognoses. In the absence of these criteria, a conventional subthyroid tracheostomy was usually performed.

Tracheostomy
Indications for tracheostomy included the following: (1) a requirement for prolonged mechanical ventilation (eg, tetraplegia or polyradiculoneuritis); (2) difficulty in weaning a patient from the ventilator (eg, brain injury or stroke); (3) the need for definite assisted ventilation (eg, patients with chronic respiratory insufficiency); and (4) major facial trauma. The date of tracheostomy was decided by the attending physician.

All tracheostomies were planned and performed at the patient bedside, in the ICU, by the four trained intensivists of the medical staff. Surgical equipment, aseptic conditions, and lighting levels were identical to those encountered in the operating theater, and all procedures were performed with the patient under general anesthesia. The patient’s ECG, oxygen saturation, arterial pressure, and tidal volume were monitored continuously during surgery. After a fasting period of at least 10 h, the tracheostomy was performed under volume-controlled ventilation with a fraction of inspired oxygen of 1. Extension of the neck was obtained by placing a small pillow between the shoulder blades. In all patients, tracheostomy cannulas with low-pressure cuffs were used (ULTRA Trachéoflex; Rusch; Kernen, Germany). Irrespective of the technique used, the diameter of the cannula was chosen according to both the size of the stoma and the diameter of the trachea.

A conventional subthyroid tracheostomy was performed according to the technique previously described by Heffner et al.9 Briefly, after the separation of subcutaneous tissue and underlying muscles, a horizontal incision or a small window was made between the second and third tracheal rings, without ligation of the thyroid isthmus. The endotracheal tube then was removed, and a cannula was inserted into the distal trachea under visual control. The skin then was sutured on both sides.

Cricothyroidotomy was performed using the technique previously described by Brantigan and Grow,8 whereby the cricothyroid space was precisely located by palpation below the thyroid cartilage. A horizontal incision of the cricothyroid membrane was performed and cannulated. The surgical procedure closely followed that employed in conventional tracheostomy, the main difference being the more superficial location of the cricothyroid membrane.

Chest radiographs were obtained at the bedside immediately after the tracheostomy and the following day. The timing for decannulation was determined by the attending physician, whether patients were still hospitalized in the ICU or not.

Follow-up
A complete laryngeal examination was performed in each patient at the following times: (1) before ICU discharge; (2) prior to decannulation; and (3) 6 months after the tracheostomy. Additional laryngeal examinations were performed as required (eg, accidental decannulation or new onset symptoms potentially related to the tracheostomy). All examinations were performed by a trained otolaryngologist and included a two-stage endoscopic examination (Olympus; Tokyo, Japan) that was performed with the patient under local anesthesia (lidocaine). First, a fiberscope was introduced nasally to visualize the upper portion of the larynx and to assess the functionality of the vocal cords. Second, the fiberscope was introduced through the stoma (the cannula having been temporarily removed) to allow a complete examination of the trachea. In addition, whenever possible, patients were questioned about symptoms related to the tracheostomy surgery.

Complications were classified into one of the following categories: immediate complications, for events directly related to the surgical procedure; early complications, when occurring during the ICU stay; and late complications, when diagnosed after the patient had been discharged from the ICU and during the 6-month follow-up period. Each complication was graded as major or minor, according to its clinical relevance. A complication was defined as minor when it caused mild or moderate discomfort (eg, transient laryngeal edema or tracheal granulation). A major complication resulted in severe sequelae or life-threatening lesions (eg, subglottic stenosis, chronic dysfunction of the vocal cords, or esophagotracheal fistula).

Irrespective of its severity, a complication was considered only once during the follow-up period. For example, a complication occurring during surgery that persisted after discharge from the hospital was considered only as an immediate complication. If the complication persisted beyond the follow-up, it was considered as a sequela. Infection-related complications were not recorded.

Statistical Analysis
Patients characteristics and the incidence of tracheostomy complications were compared between both groups (subthyroid tracheostomy group vs surgical cricothyroidotomy group). Qualitative variables were compared using a {chi}2 test, or a Fischer Exact Test when appropriate. All quantitative parameters were compared using a Mann-Whitney rank sum test. Results were expressed as the mean ± SD. For all comparisons, a p value of < 0.05 was considered to be statistically significant.


    Results
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Study Population
During the study period, 1,574 patients were admitted into our ICU. Tracheostomy was performed in 118 consecutive patients (7.5%), who constituted the study population (mean age, 54 ± 18 years; 79 men, 39 women; APACHE II score, 19 ± 2). Among them, 86 patients (73%) underwent conventional subthyroid tracheostomies, while the 32 remaining patients (27%) underwent surgical cricothyroidotomies. The reasons for admission to the ICU were as follows: acute medical condition, 57 patients (48%); postoperative complications, 16 patients (14%); and multisystem trauma, 45 patients (38%). Tracheostomy was performed for prolonged ventilation in 73 patients (62%), because of difficulty in weaning from the ventilator in 25 patients (21%), because of an advanced stage of chronic respiratory insufficiency in 14 patients (12%), and due to severe facial trauma in the remaining 6 patients (5%).

With the exception of mean age and body mass index, the patients’ characteristics were comparable in both groups (Table 1 ). Importantly, the reason for admission to the ICU, the indications for tracheostomy, the duration of mechanical ventilation, as well as the number of endotracheal intubations prior to undergoing a tracheostomy were similar between groups. The duration of cannulation tended to be longer in patients who had undergone cricothyroidotomies (Table 1) . Not surprisingly, the factors predictive of technical difficulties for the performance of tracheostomy were more frequently recorded in patients who had undergone a surgical cricothyroidotomy when compared to the group of patients who had undergone a subthyroid tracheostomy (10 of 32 patients vs 7 of 86 patients, respectively; p = 0.004) [Table 1 ].


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Table 1. Patient Characteristics in Both Study Groups*

 
For the entire study population, the ICU and overall mortality rates at the end of the 6-month follow-up period were 9% and 22%, respectively. The mortality rate tended to be higher in patients who had undergone surgical cricothyroidotomy, although the APACHE II score was not significantly higher than that of patients who had undergone conventional operations (Table 1) . However, no death could be attributed directly or indirectly to the tracheostomy, irrespective of the technique used. Among patients who were alive at the end of the follow-up period, 32 (35%) still had a tracheostomy cannula in place, with a similar proportion in both groups (24 of 70 patients vs 8 of 22 patients, respectively; p = 1).

Complications
During follow-up, 40 complications occurred in 36 patients (30%). Four of these patients developed two complications. Serious complications were observed in six patients (5%), with a similar incidence in both groups (surgical cricothyroidotomy group, 4 of 86 patients; subthyroid tracheostomy, 2 of 32 patients; p = 0.9). Minor complications were recorded in 30 patients (25%), with a similar proportion between groups (26 of 86 patients vs 8 of 32, respectively; p = 0.7).

The severity and delay of complications occurring after tracheostomy in patients from both study groups are detailed in Table 2 . The incidence of immediate, early, and late complications was similar in patients who underwent either a subthyroid tracheostomy or a surgical cricothyroidotomy (immediate complications, 6 of 86 patients vs 1 of 32 patients, respectively [p = 0.73]; early complications, 18 of 86 patients vs 7 of 32 patients, respectively [p = 0.89]; and late complications, 6 of 86 patients vs 2 of 32 patients, respectively [p = 0.78]). Mild bleeding was the most frequent immediate complication that always resolved by applying local packing. All bleeding complications occurred in patients with coagulopathy (4 of 86 patients vs 1 of 32 patients, respectively; p = 0.88). No episodes of hypotension or needing blood transfusions were noted. One patient who had undergone a conventional subthyroid tracheostomy sustained a bilateral tension pneumothorax due to mediastinal cannulation, requiring immediate bilateral pleural drainage, whereas tracheal cannulation was difficult to perform in another patient (Table 2) .


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Table 2. Delay and Severity of Complications Observed During the 6-Month Follow-up Period in Both Study Groups

 
Severe early postoperative complications occurred in five patients (Table 2) . One patient from each group developed a subglottic stenosis that subsequently required the implantation of an endotracheal tube. A patient with a subthyroid tracheostomy had persistent paralysis of both vocal cords, while another patient who required ventilation developed hypoxic bradycardia secondary to accidental tube displacement and a difficult recannulation of a deep trachea. In a single patient who had undergone a cricothyroidotomy, an asymptomatic tracheoesophageal fistula was observed, which spontaneously resolved after decannulation. Swelling of the stoma due to wound infection was the most minor and earliest complication that was observed most frequently. In all patients, these lesions rapidly resolved by the local application of silver nitrate solution.

No major late complication was observed (Table 2) . After discharge from the ICU, eight patients presented with minor complications, including a persistent scar that required cosmetic surgery (three patients), chronic suppuration associated with a persistent wound (one patient), and tracheal granulations that healed under systemic corticotherapy (four patients) [Table 2 ].

Two of the six patients who presented with major complications had sequelae when examined 6 months after undergoing the operation. Paralysis of the vocal cords persisted in one patient from the conventional subthyroid tracheostomy group, while another patient from the same group had a persistent subglottal stenosis after the endotracheal tube was removed (Table 2) . Finally, no ulceration of the innominate artery was observed.


    Discussion
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Surgical tracheostomy is traditionally performed in the operating room by surgeons. In order to avoid the potential risks associated with the transportation of critically ill patients and delays in the procedure due to operating room scheduling, alternative tracheostomy techniques have been developed. Bedside tracheostomy was first proposed as an alternative to conventional tracheostomy.4 10 11 Bedside percutaneous dilatation tracheostomy, performed by intensivists, has been used increasingly in the ICU.4 12 13 14 Accordingly, most studies have compared the morbidity for the conventional subthyroid tracheostomy performed in the operating room to that for bedside percutaneous dilatation procedures.5 As far as we know, this is the first prospective study evaluating the complications associated with both subthyroid tracheostomy and surgical cricothyroidotomy performed at the patient’s bedside in the ICU, including late events occurring during a 6-month follow-up period after the surgical procedure.

Incidence and Severity of Complications Associated With Bedside Surgical Tracheostomy
In the present study, when excluding infection-associated complications, a 30% incidence of complications related to the surgical tracheostomy was observed, with only 5% of the them classified as major events. In addition, no death was attributed to surgical tracheostomy, irrespective of the technique used (Table 2) . In the operating room, complications attributed to surgical tracheostomy have been reported previously2 3 4 15 in 6 to 66% of patients. This wide range presumably reflects the large variety of complications encountered and the heterogeneity of the study populations.

In this prospective series, the 6% incidence of immediate complications attributed to surgical tracheostomy (Table 2) was similar to that reported with percutaneous dilatation procedures.5 Importantly, none of our patients was excluded from the current study based on functional or anatomic criteria, whereas patients at high risk for tracheostomy-related complications (eg, distortion of the neck anatomy, morbid obesity, or severe coagulopathy) have not been studied in prospective trials evaluating percutaneous dilatation tracheostomy.5 13

Interestingly, all major complications were noted while our patients were still hospitalized in the ICU. In addition, most complications occurred after the surgical tracheostomy, rather than during the procedure (Table 2) . A bilateral pneumothorax (0.8%) was the single severe complication that was immediately diagnosed at the time of surgery. The low incidence of pneumothorax in our series was similar to that (4%) previously reported by Crofts et al.16 In the present study, accidental decannulation led to acute respiratory failure in a single patient. The incidence of this life-threatening complication has been reported in up to 15% of patients.5 Tracheoesophageal fistulas have been historically described following conventional surgical tracheostomy. In the present series, an asymptomatic tracheoesophageal fistula, which spontaneously resolved after decannulation, was diagnosed during endoscopic follow-up in a single patient (Table 2) . This severe lesion appeared to be secondary to a sustained local injury by the tracheal cannula, rather than being directly related to the surgical procedure. Chronic dysfunction of the vocal cords, such as that observed in one of our patients (Table 2) , also has been described after surgical tracheostomy. In our patient, an irreversible traumatic injury to both recurrent nerves may explain the chronic dysfunction noted in both vocal cords. Finally, a subglottic stenosis was observed in two of our patients (1.7%) [Table 2 ]. Although routine tracheal endoscopic examination is usually advocated for the early diagnosis of this severe complication,17 18 only a little information is currently available regarding the systematic follow-up of critically ill patients who have undergone surgical tracheostomies in the ICU. Using tracheal tomography without direct endoscopic examination, Stauffer et al3 reported a 10% narrowing of the tracheal diameter in 65% of cases. The diagnostic criterion and technique used in that study3 presumably account for the high incidence of tracheal stenosis compared to our study. The widespread use of tracheostomy cannulas with low-pressure cuffs has considerably diminished the incidence of tracheal stenosis despite long periods of cannulation,19 20 as shown in the present study.

Minor complications were diagnosed in 29% of the patients and constituted 85% of the tracheostomy-related events (Table 2) . Most of them occurred during the ICU stay and resolved spontaneously or remained asymptomatic during follow-up.

All these findings suggest that elective surgical tracheostomy performed at a patient’s bedside in the ICU by a trained operator is a safe procedure. As such, this procedure is a valuable alternative to conventional tracheostomy performed in the operating theater in severely ill patients.

Conventional Subthyroid Tracheostomy vs Surgical Cricothyroidotomy
Cricothyroidotomy, which is easier, quicker, and safer to perform than conventional subthyroidotomy, due to the absence of major nerves or blood vessels in the surrounding tissues, is the most widely advocated surgical technique for emergency tracheostomy.21 22 23 24 However, the potential threat of severe subglottic stenosis that accompanies this procedure25 26 explains why subthyroid tracheostomy frequently remains the first-line surgical technique that is used routinely in patients requiring prolonged mechanical ventilation.

In the current study, both groups were comparable in terms of severity score, indications for tracheostomy, and length of ICU stay (Table 1) . In addition, both the duration of mechanical ventilation and cannulation, and the number of endotracheal intubations prior to tracheostomy, which may contribute to early complications,27 28 were similar between groups (Table 1) . Despite the greater proportion of patients with factors traditionally associated with technically difficult tracheostomies, the overall incidence of complications attributed to surgical cricothyroidotomy was similar to that observed in patients who had undergone subthyroid tracheostomies (Table 2) . This finding is presumably related to the relative ease of performance of cricothyroidotomy. Since no deaths were attributed to surgical tracheostomy, the higher mortality rate observed in the cricothyroidotomy group was presumably due to the older age of these patients. In addition to being technically easier to perform, there is a preference for the performance of surgical cricothyroidotomy in patients with poor prognoses.

Not surprisingly, immediate complications were observed predominantly in patients who had undergone conventional subthyroid tracheostomies (Table 2) . Mild bleeding was the most frequent complication that was directly related to conventional tracheostomy, as previously reported.5 Interestingly, all patients who had experienced bleeding events had coagulopathies. The absence of thyroid isthmus ligation, performed according to the technique described by Heffner et al,9 also may have played a role, since this complication occurred predominantly after a patient had undergone a subthyroid tracheostomy (Table 1) . Importantly, no hemodynamic instability or need for transfusion was noted. These findings presumably are related to the relatively deep location of the second and third tracheal rings, when compared to the superficial cricothyroid membrane. This makes the conventional subthyroid tracheostomy somewhat more difficult to perform and may lead to more frequent perioperative adverse events. In addition, the performance of an emergency recannulation through the cricothyroid membrane is considerably easier than through a subthyroid stoma.

In the present study, a single patient in each group developed subglottic stenosis, which was successfully treated by the insertion of an endotracheal tube. Hence, we failed to observe a higher incidence of subglottic stenosis, which requires challenging surgical repair for correction, in patients who had undergone cricothyroidotomies despite a trend toward a longer duration of cannulation (Table 1) . This is in contrast with historical reports that have stressed a frequency of laryngeal stenosis as high as 93% after high tracheostomy procedures.7 Importantly, both the indications for performing a tracheostomy and surgical techniques have changed greatly over time. Using the cannulation of the cricothyroid membrane, Brantigan and Grow8 found no case of subglottic stenosis in 655 patients, and these results were subsequently confirmed by others.29 30 31

Limitations
The main limitation of this study is that the tracheostomy technique was chosen by the referring physicians based on anatomic and functional factors, rather than by randomization. This may have introduced a substantial bias since surgical cricothyroidotomy was more frequently performed in the presence of criteria that traditionally have been associated with the performance of technically difficult conventional subthyroid tracheostomies. However, with the exception of age and body mass index, both study groups were comparable for all other characteristics (Table 1) . In addition, the power analysis showed that the size of our study population was adequate to detect a difference of 20% in the incidence of major complications (ie, immediate, early, or late) between groups (Table 2) .

In the current series, infection-related complications purposely have not been studied. Although tracheostomy contributes to the bacterial colonization of the bronchial tract, the clinical relevance of such infections remains controversial.15 32 33 34 35 In addition, a systematic serial endoscopic examination allowed exhaustive diagnoses of various asymptomatic complications that are attributable to the tracheostomy procedure.


    Conclusion
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
In the present series, major complications following bedside surgical tracheostomy performed in the ICU were observed in only 5% of critically ill patients. After a 6-month follow-up period, the incidence of complications, including subglottic stenosis, was similar in patients who had undergone conventional subthyroid tracheostomies and in patients who had undergone surgical cricothyroidotomies. Since the latter procedure is technically easier to perform, it represents a valuable alternative to conventional tracheostomy in the management of critically ill patients when performed at the bedside by experienced operators. A randomized prospective trial comparing bedside surgical cricothyroidotomy with percutaneous dilatation procedures in critically ill patients would be relevant to determine which techniques are preferable for use in the ICU.


    Acknowledgements
 
We thank Dr. Pierre-Marie Preux for his help with the statistical analysis.


    Footnotes
 
Abbreviation: APACHE = acute physiology and chronic health evaluation

Received for publication May 16, 2001. Accepted for publication May 15, 2002.


    References
 TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 

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