Tracheostomy is one of the oldest surgical procedures, and has probably existed for more than 3000 yr. Historical accounts of the operation have been reviewed in detail elsewhere (1). Tracheostomy was alluded to several thousand years ago in the ancient sacred book of Hindu medicine, Rigveda. However, it was not until the 19th century, during the diphtheria epidemics, that tracheostomy became popular. The technique of surgical tracheostomy was standardized by Chevalier Jackson (2), who published the operative details of this procedure. The standard technique of surgical tracheostomy has a complication rate of up to 66%(3–7). In 1985, Ciaglia et al. (8) described a technique of percutaneous dilatational tracheostomy (PDT) using a needle, guidewire, and multiple sequentially larger dilators. In 1989, Schachner et al. (9) developed a single dilation tracheostomy forceps over a guidewire (Rapitrach; Fresenius, Runcom, Cheshire, UK), but this was associated with dangerous complications of tracheal tear. In 1990, Griggs et al. (10) developed another guidewire dilating forceps with a smooth, rounded tip for percutaneous tracheostomy. Today, the Ciaglia’s multiple dilators kit (Cook Critical Care, Bloomington, IN) and the Griggs’ single-step dilation forceps kit (SIMS; Portex, Hythe, Kent, UK) are used worldwide for PDT, and small rates of complications are reported (11–20). The Griggs’ technique provides rapid formation of tracheostomy, whereas the Ciaglia’s multiple dilator technique takes significantly longer. In 1999, Ciaglia modified his own original technique by replacing the multiple dilators with a single tapered dilator “Blue Rhino” (Cook Critical Care). Since the introduction of Ciaglia’s Blue Rhino (CBR), only a few studies have become available (21–23). None has studied the effect on peak airway pressure during stoma formation and stoma dilation vari-ables during and after stoma formation. The aim of this study was to determine the effect on peak airway pressure during stoma dilation, the factors that can influence stoma dilation, incidence of tracheal injuries, time required in performing the procedures, and advantages/disadvantages of the two procedures.
Sixty consecutive critically ill patients requiring tracheostomy for prolonged ventilatory support, airway protection, pulmonary toilette, or facilitation of weaning from the ventilator in the intensive care unit (ICU) of this tertiary care, super-specialty teaching hospital were included. Informed written consent was obtained from next of kin and the study was prospectively approved by the institute’s ethics committee for human studies.
The patients were randomized to undergo percutaneous tracheostomy by either the CBR or the Griggs’ guidewire dilating forceps (GWDF) technique. All tracheostomies were performed by three anesthesia intensivists, who had experience performing at least 10 tracheostomies using Ciaglia’s multiple dilators technique and the GWDF technique. On completion of the procedure, bronchoscopy was performed by a blinded consultant who was not present at the time of tracheostomy and was not aware of the type of tracheostomy the patient had undergone. The report of the bronchoscopy was sealed in an envelope and was opened only after completion of the study. Routine patient monitoring included continuous electrocardiography, arterial blood pressure, peripheral hemoglobin oxygen saturation by pulse oximetry (Spo2), and end-tidal carbon dioxide (ETco2) measurement. All patients received general IV anesthesia consisting of propofol (3 mg/kg), fentanyl (3 μg/kg), and midazolam (2 mg). Neuromuscular blockade was obtained by using pancuronium titrated to achieve absence of spontaneous respiration and physical movement. All patients received controlled ventilation of lungs with an inspired oxygen concentration (Fio2) of 100% during the procedure. All male and female patients had tracheostomy tubes of 8 or 8.5 mm and 7 or 7.5 mm (inner diameter), respectively.
General patient data recorded included: age, sex, body mass index (BMI) (the weight of the patient recorded at the time of admission to the hospital was taken for calculation of the BMI), acute physiology and chronic health evaluation II score, days of translaryngeal intubation, indication for tracheostomy, thromboprophylaxis, and full anticoagulation. Routine laboratory data included hematology, biochemistry, chest radiograph, and coagulation profile. Abnormal coagulation was defined as an international normalized ratio >1.4, activated partial thromboplastin time ≥45 s, and platelet count of <75,000/mL.
In the CBR method, the patients were positioned as for conventional surgical tracheostomy by placing a pillow under the shoulders with the neck moderately extended and relevant landmarks easily identifiable. The endotracheal tube (ETT) was withdrawn under bronchoscopic visual control so that the tip lay immediately below the vocal cords. The anterior neck was prepared with povidine iodine and draped with sterile sheets. The suprasternal notch, thyroid, and cricoid cartilages and, if possible, the first three tracheal rings were identified. If the tracheal rings were not palpable, then a point between the cricoid cartilage and suprasternal notch was marked. Three to 5 mL of 1% lidocaine with adrenaline (1:200,000) was infiltrated subcutaneously to minimize the bleeding. A 2-cm transverse skin incision was made and blunt dissection of pretracheal tissues was performed by using hemostats to expose the pretracheal fascia. The anterior trachea was palpated and the intended puncture site was identified. The trachea was punctured with a 14-gauge cannula-on-needle in a posterio-caudad direction and tracheal entry of the needle was confirmed by aspiration of air into the saline-filled syringe. The ETT was rotated by 30° and movement of the tracheal cannula was eliminated. If rotation of the ETT was associated with movement of the tracheal cannula, it was presumed that impalement of the ETT had occurred. The cannula was withdrawn, and after readjustment of the ETT, a fresh tracheal puncture was made. After successful placement of the tracheal cannula, a “J” tip guidewire was passed through the cannula into the tracheal lumen; the cannula was then withdrawn, leaving the guidewire in situ. A well-lubricated initial dilator was passed over the guidewire into the trachea to start stoma formation and was later removed. A guiding catheter was advanced over the guidewire until the safety ridge of the guiding catheter lay inside the tracheal lumen. Over the guidewire and guiding catheter, the CBR was passed to the appropriate skin marking, resulting in tracheal dilation. Finally, the tracheostomy tube loaded over an appropriate and well-lubricated introducer was inserted through the tracheal stoma. The introducer, the guidewire, and the guiding catheter were then removed, leaving the tracheostomy tube in situ.
In the Griggs’ (GWDF) method, after positioning the patient in the tracheostomy position and identifying the proposed tracheostomy point, a 2-cm transverse skin incision was made as in the CBR method. The trachea was cannulated with a 14-gauge cannula and its placement into the tracheal lumen was confirmed on aspiration of air in the saline-filled syringe. The impalement of ETT was excluded. A “J” tip guidewire was passed into the tracheal lumen through the catheter, which was then removed. The initial dilator was passed over the guidewire to start the stoma formation and was later removed. The GWDF, with its jaws closed, was advanced over the guidewire until resistance was felt. Opening the forceps allowed dilation of the soft pretracheal tissues. The forceps were then reapplied to the guidewire and advanced until the jaws passed into the tracheal lumen. Free movement of the guidewire through the closed jaws of the GWDF was ensured. The handles of the forceps were then raised to align the jaws in the long axis of the trachea. One-step dilation of the anterior wall of the trachea was achieved by using two-handed opening of the forceps to allow subsequent passage of a tracheostomy tube of the desired size. After formation of stoma, the GWDF was removed in the open position, leaving the guidewire in situ. A cuffed tracheostomy tube with its specially designed obturator was advanced over the tracheal guidewire and inserted through the tracheal stoma. The obturator and guidewire were then removed.
After placement of the tracheostomy tube with either method, tracheal suction was performed, the tracheal cuff was inflated with air, and ventilation of the patient’s lungs was resumed through the tracheostomy tube. Air entry into the lungs was confirmed by chest auscultation and respiratory plethysmography, and a chest radiograph was ordered.
The time taken to perform the procedure (skin incision to successful placement of tracheostomy tube) was noted. During the procedure, observations were made for difficulty in dilating the tracheal stoma, number of attempts at stoma dilation, or insertion of the tracheostomy tube. If more than one attempt was necessary and repeat stoma dilation was required, the cannulation was considered difficult and the stoma was classified as under-dilation. Complications such as bleeding from the stoma, hypoxia (Spo2 < 95%), hypercarbia (≥5 mm increase in ETco2 from the baseline), increase in airway pressure from its baseline, hypotension (>20% decrease in systolic pressure), hypertension (>20% increase in systolic pressure), and technical difficulties were recorded. Bleeding was classified in four grades: I = ≤5 mL, II = 6–10 mL, III = 11–50 mL or >10 mL of blood in the tracheal aspirate, and IV = >50 mL. All patients had a chest radiograph before PDT, within an hour after PDT, and the next day after PDT. The radiographs were examined for pneumothorax, pneumomediastinum, atelectasis, position of the tracheostomy tube, and other changes.
Flexible fiberoptic bronchoscopy was performed, and the trachea was inspected for injuries, fracture of cricoid/tracheal cartilage rings, and the extent of stoma dilation. When there was a clear mucosal tear, it was recorded as mucosal lacerations, but if the mucosa was intact and only redness or bluish discoloration was seen, then it was classified as abrasion. The stoma dilation was classified as adequate dilation (stoma restricted to the anterior wall of the trachea), over-dilation (stoma margins extending to more than half of the anterior circumference), or near total transection (when more than two-thirds of the tracheal circumference was dilated).
Postoperatively, the patients were followed throughout their hospital stay for bleeding, infection at the stoma site, accidental tracheal decannulation, and difficulty during change of the tracheostomy tube. Stoma infection was considered when there was purulent drainage from the site. The survivors were evaluated after 8 wk of decannulation for the nature of tracheostomy scar, change in voice, and difficulty in breathing.
Data were analyzed using Student’s t-test for continuous variables and Fisher’s exact test for categorical variables. Statistical significance was accepted at 95% confidence level (P < 0.05).
Age, sex, BMI, mean duration of translaryngeal intubation, major underlying disease processes, acute physiology and chronic health evaluation II, and hemodynamic variables at the time of PDT were comparable between the groups (Table 1). The procedure-related technical difficulties and complications are shown in Table 2. All patients in the CBR group had significant increases in peak airway pressure (mean 16.5 ± 5 cm H2O from the baseline value) during stoma dilation whereas the increase in peak airway pressure in the GWDF group was not significant (6 ± 2.5 cm H2O from the baseline). The difference in the increase in peak airway pressure between the two groups was highly significant (P < 0.01). Two patients of the CBR group had a sudden decrease in arterial blood pressure (systolic blood pressure <80 mm Hg) with 3–6 ventricular ectopics during tracheal dilation, but this improved after withdrawal of the CBR. None of our patients showed significant arterial desaturation or hypercarbia in either group. One patient in the CBR group and 5 patients in the GWDF group had blood loss between 11 and 50 mL, whereas in the other patients blood loss was minimal. The average time taken to complete the procedure with the CBR method was 7.5 ± 2.5 min and with the GWDF method was 6.5 ± 4.5 min (P > 0.05).
In two patients of the CBR group, the operator encountered difficulty in passing the tracheostomy tube after the first attempt and required redilation with the CBR. On a few occasions, the operator had lost his grip over the CBR during the stoma dilation. In the GWDF group, it was difficult to judge the formation of adequate size of tracheal stoma. In 21 patients, the tracheostomy tube was inserted on the first attempt at tracheal dilation whereas 9 patients required a second attempt. On bronchoscopy, 3 patients in the GWDF group were detected to have transverse mucosal lacerations in the anterior tracheal wall approximately 3–4 cm down to the tracheal stoma, whereas 2 patients in the CBR group had longitudinal mucosal abrasions in the posterior tracheal wall. Nine (33%) patients in the CBR group had fracture of 1, 2, or 3 tracheal rings and, of these patients, 3 also had fracture of cricoid cartilage. In the CBR group, none of the patients had over-dilation of the tracheal stoma, whereas over-dilation was seen in seven patients of the GWDF group and three of these patients had splitting of more than two-thirds of the tracheal circumference. Five of the nine patients with a BMI ≥22 had over-dilation of the tracheal stoma. With the GWDF technique, the incidence of under-dilation of tracheal stoma was more frequent in the first half of the study than in the latter half (6:3) and with operators who had performed fewer than 15 tracheostomies. Conversely, the incidence of over-dilation was more frequent in the latter half of the study than the first half (2:5), and with the operators having comparatively more experience. We observed that the tracheal tissues of young patients were easily dilated whereas much force was required in the calcified tracheas of geriatric patients. Three patients in the GWDF group developed mild to moderate surgical emphysema over the neck and chest. None of the patients in the GWDF group had pneumothorax, whereas one patient in the CBR group developed pneumothorax and required intercostal chest drainage.
Although many patients had pneumonic consolidation and suppurative pulmonary parenchymal infection, only one patient in the CBR group and two in the GWDF group showed purulent infection at the stoma site. There was no evidence of new parenchymal infection, late bleeding, tracheoesophageal fistula, or aspiration associated with PDT. No difficulty was encountered during change of the tube in any of the groups. During ICU stay, 12 (40%) patients of the CBR group and 15 (50%) patients of the GWDF group died from multiorgan failure attributed to a progressively worsened disease process. One obese, short-necked patient in the GWDF group had accidental tracheal decannulation during change of posture on the second day of tracheostomy and suffered hypoxic brain insult before the airway was secured by endotracheal intubation. Among 33 survivors, 30 were decannulated successfully. After tracheal decannulation, the stoma closed completely within 48–72 h in both groups. Three patients, because of very poor gag reflex, continue to have a tracheostomy tube. At a follow-up of 8 wk, although none of our decannulated patients presented with symptomatic tracheal stenosis, 3 patients of the CBR group who had fracture of cricoid and tracheal cartilaginous rings reported with tracheal in-drawing at the scar site with significant huskiness in their voice. However, none of these patients had obvious difficulty in breathing.
Elective tracheostomy in patients on long-term ventilatory support is a widely accepted procedure in the ICU. With the advent of the Seldinger guidewire technique, PDT has almost replaced the surgical tracheostomy. Although a number of percutaneous techniques have been introduced in the past two decades, the Ciaglia (8) and the Griggs’(10) techniques are the most common in use (11–20). Experiences with dilatational tracheostomy have generally been favorable, with claims that, in comparison with conventional methods, they are safer, easier, and quicker to perform at the bedside and are associated with fewer complications (12–16,24). Not all studies that compared PDT with standard tracheostomy demonstrated reduced complications, however (25,26). A meta-analysis of studies comparing PDT versus surgical tracheostomy has been published (27) in which PDT was found to be associated with an increased incidence of perioperative complications. However, in that meta-analysis, the authors did not take into account the different techniques used, or the fact that each technique has its own method and complication rates (28).
In our series of 30 patients in each study group, the PDT was not associated with clinically important hemorrhage (blood loss requiring blood transfusion or surgical intervention), purulent infection at the stoma site, or any lethal complication. Escarment et al. (29) required two to three forceps dilatations in two-thirds of their patients to achieve successful insertion of the tracheostomy tube, and they found that insertion of a tracheostomy tube is rarely achieved on the first attempt with the GWDF. In our study, only one-third of the patients of the GWDF group required a second dilation and none required a third dilation before successful insertion of the tracheostomy tube. This difference could have been attributed to the use of the recently introduced Portex Blue line Ultra Soft Seal Cuff Tracheostomy Tube (REF 100/800/085; SIMS Portex Ltd.), which has a smooth tapered distal end along with an improved obturator which facilitates easy insertion of the tube, whereas Escarment et al. (29) used an older version of the tracheostomy tube that had a blunt end.
Although there have been a number of studies on forceps dilatational tracheostomy, none has measured the extent of tracheal dilation. During the formation of tracheal stoma, there are three important factors: patient factors, instrument factors, and operator factors. The BMI, thickness of soft tissues overlying the trachea, site of the proposed tracheostomy, calcification of tracheal cartilaginous rings, and prolonged duration of translaryngeal intubation making the tracheal tissues soft and fragile, may affect the dilation kinetics of the tracheal stoma. The strength and experience of the operator may also influence the formation of tracheal stoma. We have observed that the less experienced and less strong operators open the forceps very hesitantly, leaving the stoma under-dilated on the first attempt and sometimes on the second attempt as well. This makes the insertion of a tracheostomy tube difficult. The GWDF lacks the check mark for insertion of the forceps (i.e., how much the distal end of the forceps is to be inserted inside the trachea, at what level of forceps the stoma is to be dilated, and how much is to be dilated for a particular size of tracheostomy tube), making tracheal dilation uncontrolled and blind. In obese patients, it is difficult to gauge the length of the forceps insertion inside the tracheal stoma because of abundance of pretracheal tissues and therefore its dilation for the particular size of tracheostomy tube. The GWDF is opened using both hands without any control point, and this leaves the stoma either under- or over-dilated. Over-enthusiastic attempts at dilation may result in over-dilation or occult subtotal transection of the trachea and excessive bleeding. Nates et al. (18) have postulated that excessive bleeding and other surgical complications of the GWDF technique are caused by uncontrolled dilation of the trachea, and we agree with this opinion.
The rupture of cricoid cartilage or tracheal rings with the CBR is a cause of major concern. In our series of 30 patients, 9 (30%) patients had rupture of tracheal cartilage rings. Byhahn et al. (21,22) have reported 25% and 36% incidence of rupture of tracheal cartilage rings. They have attributed this complication to the rapid one-step dilation. Our results are comparable. Edwards and Williams (30) also have shown that the CBR technique is associated with tracheal cartilage fracture. In our series, most of the patients who had tracheal ring ruptures were older. The rigid calcified tracheal rings of elderly patients do not conform to the stoma shape on rapid insertion of the dilator and therefore are prone to rupture. Although it is said that tracheal cartilage fractures after PDT rarely result in tracheal strictures or stenosis of clinical relevance after decannulation (20), further studies are required. Friedman (31) has warned that tracheal ring rupture could lead to long-term tracheal abnormalities. Although we did not encounter any case of posterior tracheal wall perforation with the CBR technique, Westphal et al. (32) reported a case of this potentially lethal complication. During stoma formation with the CBR, there is a significant increase in peak airway pressure. The increase in peak airway pressure is attributed to two factors: 1) the simple size of the Blue Rhino dilator, which occupies a large portion of the tracheal lumen and thus decreases tracheal cross-sectional area and increases resistance, and 2) the fact that the tracheal lumen is also compressed by the pressure required to pass the dilator over the guidewire. More important than the increased peak airway pressure is the potential for expiratory obstruction and dynamic hyperinflation of the lungs. This may indirectly cause an increase in intracranial pressure and lung parenchymal disruption. We fear that this potential increase in intracranial pressure may be dangerous in patients with intracranial pathology, and therefore CBR may not be the method of choice for the PDT in this population. However, further studies are required to corroborate it.
With bronchoscopic assistance, the tip of the ETT as well as the needle puncture site in the midline of the trachea and dilation of the tracheal stoma can be visualized. We deliberately did not do the tracheal puncture and stoma dilation under direct bronchoscopy, because presence of a bronchoscope and the CBR both may increase the airway pressure drastically and jeopardize adequate minute ventilation. One of our patients, an 80-year-old who developed pneumothorax after the CBR dilation, did not exhibit any injury to the tracheal wall even on repeat bronchoscopy. Therefore, the pneumothorax that occurred in this case could have been caused by rupture of a emphysematous bulla as a result of an increase in peak airway pressure and air trapping. The dynamic hyperinflation of lungs could also be implicated in decreasing the venous return and thereby causing significant hypotension and ventricular ectopics in two of the CBR patients.
The main advantage of PDT with either method is that its performance in the ICU as a bedside procedure prevents unnecessary delays and risks of transfer to the operating room. We have found that PDT with the CBR method is as quick and effective as the GWDF method and can be performed by the attending intensivists. However, the CBR method has the major risks of rupture of tracheal rings, increase in airway pressure, and air trapping, whereas the GWDF method has the risks of over-dilation/subtotal transection of the trachea. The long-term sequelae of these complications are yet to be evaluated. Although we have come a long way in making the procedure of tracheostomy available at the bedside and cost-effective, there is still a long way to go to make this procedure risk free.
The authors thank the surgical ICU and cardiothoracic ICU nurses, radiographers, and respiratory physiotherapists at Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, for their much needed cooperation and assistance during this study. The statistical assistance of Dr. Chandra Mani Pandey, MSc, PhD, in analyzing the data is also appreciated.
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