The era of modern percutaneous tracheostomy began in 1955, when Shelden et al. (1) described a percutaneous tracheostomy device. However, the procedure often resulted in fatalities and therefore did not gain acceptance (2,3). Further investigations were done in this area, and Toye and Weinstein (2) introduced another device for percutaneous tracheostomy in 1969. It is not clear, however, why Toye and Weinstein’s technique did not also become popular. In 1985, Ciaglia et al. (4) introduced percutaneous dilational tracheostomy (PDT), which turned out to be a breakthrough in percutaneous tracheostomy. Within the last 15 yr, PDT has been as safe as and more cost-effective than conventional tracheostomy (5–12). Currently, in intensive care medicine, most tracheostomies are done percutaneously, and PDT has become the most popular among a number of percutaneous techniques (13). Despite its high level of safety, severe complications have been reported, of which most occurred during the process of the stepwise dilation of the tracheostoma.
Ciaglia Blue Rhino (CBR; Cook Critical Care, Bloomington, IL) represents a major modification of PDT and is different, in that the dilation of the stoma is formed in one single step by means of a hydrophilically coated, curved dilator—the “Blue Rhino.” Therefore, the risk of injury to the posterior tracheal wall and/or intraoperative bleeding episodes are reduced, and adverse effects on oxygenation during repeated airway obstruction by the dilators as described for PDT (14) are less.
The primary aim of the present study was to determine whether CBR provides advantages over PDT. Therefore, practicability, perioperative complications, and patient outcome were evaluated in 50 critically ill patients who had either CBR or PDT.
During a 5-mo period, a prospective, randomized clinical trial was performed. With the informed consent of their relatives, 50 critically ill adults from three intensive care units (ICUs) of our hospital (36 beds in total equipped with ventilator) received elective tracheostomy either according to CBR or PDT techniques, provided extubation was unlikely within 10 days. The leading diagnoses for admission to the ICU and complications during long-term ventilation are presented in Table 1.
Patients who had an infection of the tracheostomy site were excluded from the study, as well as those with known or expected difficult translaryngeal intubation. Also, patients whose trachea could not clearly be identified by palpation were excluded
All tracheostomies were performed at the bedside on the ICU and under general IV anesthesia, using propofol, fentanyl, and pancuronium. Ten minutes before the tracheostomy procedure, the positive end-expiratory pressure (PEEP) was reduced stepwise to 5 cm H2O if necessary, and all patients received positive-pressure ventilation with 100% of oxygen throughout tracheostomy. After insertion of the tracheostomy tube, the fraction of inspired oxygen (Fio2) and the PEEP were set to the preoperative levels. If under this regimen hemoglobin saturation (Sao2) measured by pulse oximetry decreased below the preoperative level, the Fio2 was increased stepwise until the baseline Sao2 was reestablished. Beside pulse oximetry, intraoperative monitoring consisted of invasive blood pressure monitoring and electrocardiogram.
To assess the influence of tracheostomy on the patient’s oxygenation, arterial blood gas samples were obtained before tracheostomy and again after completion of the procedure and reestablishment of the preoperative Sao2.
Technique of PDT and CBR
Regardless of the technique used, the patient’s neck was slightly reclined, and the surgical area was cleansed and prepared with surgical drapes in typical manner. A flexible fiberoptic bronchoscope was used in every instance. PDT was performed according to Ciaglia’s technique, which has been described elsewhere in detail (4), using the Ciaglia Percutaneous Tracheostomy Introducer Set (Cook Deutschland GmbH, Moenchengladbach, Germany). The tracheostomy tubes used for PDT were 8.0 mm (n = 3) and 9.3 mm (n = 22) in internal diameter (Mallinckrodt Medical GmbH, Hennef, Germany).
In the case of CBR, we used the CBR Percutaneous Tracheostomy Introducer Set (Cook Critical Care). The set consisted of a puncture needle, a guidewire, a small dilator and the special Blue Rhino dilator, and three curved stylets for placement of the tracheostomy tube. The set does not contain the tracheostomy tube.
As for PDT, we used cannulas of 8.0 (n = 5) and 9.3 mm (n = 20) internal diameter (Mallinckrodt Medical GmbH). To facilitate access to the trachea, the endotracheal tube in place was withdrawn under direct laryngoscopy to the level of the glottic opening, and the trachea was punctured in midline between the 2 and 3 tracheal cartilage rings. The guidewire was then introduced by using Seldinger’s technique. After withdrawal of the needle and introduction of the guiding catheter, the puncture canal was predilated with the small dilator. The Blue Rhino dilator is a flexible, hollow tube of hard rubber with a special hydrophilic coating (EZ-Pass™ Hydrophilic Coating; Mallinckrodt Medical GmbH). To increase the dilator’s external smoothness, it was wetted with a few milliliters of saline solution or distilled water. The dilator was then advanced over the guidewire and guiding catheter through the soft tissues and into the trachea up to its marking of 38F external diameter. Because of the dilator’s smoothness, dilation required a minimum of force.
The set contains three hard rubber stylets of different sizes with cone-shaped tips. As a result, once the tracheostomy tube is armed with its corresponding stylet, tube and stylet form a perfectly fitting unit, in particular at the interface of tube and stylet. This unit was advanced over the guidewire into the trachea, and once the stylet was withdrawn and the correct position of the tracheostomy tube was confirmed bronchoscopically, the tube was connected to the respirator. Thereafter, the endotracheal tube was removed.
Once the homogeneity of the data was confirmed, the Wilcoxon-Mann-Whitney Test was used to compare the data in terms of mean and sd, whereas Fisher’s exact test was used to compare contingencies. All statistical calculations were performed by using GraphPad InStat® Version 3.00 (GraphPad Software, Inc., San Diego, CA). Statistical significance was confirmed with a probability of error < 5% (P < 0.05).
Fifty consecutive adult ICU patients (29 men, 21 women) on long-term ventilation received elective tracheostomy during a 5-mo period. No patient was excluded from the study because of contraindications. Tracheostomy was performed in 25 patients each by either Ciaglia’s basic technique of PDT or the new CBR technique at the patient’s bedside. Before tracheostomy, the patients were translaryngeally intubated with oral (n = 48) or nasal (n = 2) tubes (p < 0.0001) for a mean of 7.2 ± 3.8 days (range: 2–19 days) in CBR and 7.5 ± 3.7 days (range: 1–18 days) in PDT, respectively (P not significant).
The operating time was defined as the interval from puncture of the trachea until connection of the tracheostomy tube to the respirator. In case of CBR, the mean operating time of 165 ± 78 s (range: 50–360 s) was significantly shorter than the time required for PDT, which was 386 ± 283 s (range: 4–20 min) (P < 0.0001).
During the study, 18 complications were noted in the 17 patients. Sixteen complications occurred intraoperatively, and only one complication was recorded for the in situ period between tracheostomy tube placement and decannulation or patient death. All complications are listed in Table 2.
The complications during CBR procedures included fractures of isolated tracheal cartilages in nine patients, which were detected bronchoscopically during the process of one-step dilation, and another two short periods of oxygen desaturation without adverse sequelae. The total number of complications recorded during PDT was less; however, the complications were more severe and partly life threatening. In two patients, the posterior tracheal wall was perforated during dilation. One of them subsequently developed a pneumothorax severe enough to require chest tube insertion. In both patients, PDT was completed uneventfully, and none of the patients showed signs of hypoxia or hemodynamic instabilities during the procedure. In contrast to CBR, tracheal cartilage fractures were noted in only two patients during PDT (P < 0.05). Regardless of whether CBR or PDT was performed, none of the patients who suffered a tracheal ring fracture required further intervention. During both CBR and PDT, the oxygenation variables remained almost stable (see Table 3).
With regard to in situ complications, one patient of the PDT group had a bleeding episode from the stoma’s wound edges 15 days after tracheostomy. In this patient, an elective tracheostomy tube change had been performed a few hours previously, during which the 9.3-mm tube was replaced by an 8.0-mm tube. The bleeding ceased spontaneously once the 8.0-mm tube was replaced by a 9.3-mm tube. During the course of cannulation, no other complications such as premature decannulations, stoma infections, etc., occurred, regardless of the technique used for tracheostomy.
The patients stayed cannulated for an average of 17.3 ± 14.5 days (range: 5–52 days) after CBR, and 17.1 ± 13.0 days (range: 4–49 days) when PDT was performed, respectively (P not significant). Ten patients of the CBR group and 10 of the PDT group were successfully decannulated during their hospital stay. Eleven CBR patients died cannulated (PDT: 8) as a result of their underlying disease or its complications, and four patients who had CBR (PDT: 7) were discharged to a secondary or tertiary care hospital with the tracheostomy tube still in place.
PDT has become the preferred technique for percutaneous tracheostomy (13). Since its introduction in 1985, the technique has been modified, principally by bronchoscopic guidance during tracheal puncture and dilation (15). As a result, severe complications from “blind” puncture and dilation have become less common, but they cannot definitively be excluded. After 15 years of clinical practice, both technique and materials for PDT have reached a maximum level of elaboration and technical perfection. Efforts to further improve practicability and safety of PDT resulted in the generation of CBR, which is not a completely new technique for percutaneous tracheostomy, but rather an extensive modification of PDT. In contrast to PDT, it requires only a single dilation with a special curved dilator. Its hydrophilic coating allows rapid and almost effortless dilation of the puncture canal. During PDT, dilation requires both much more force and considerably more time.
As demonstrated, it took an average of more than 6 minutes to complete PDT. This is in accordance with the recent literature in which PDT reportedly required 4.9–21.5 minutes (7–10,14). Regardless of the fact that CBR represents a new technique and that we had only minor experience from 20 previously performed CBRs (16), the procedure was completed in < 3 minutes on the average. This makes CBR comparable to the Griggs’ technique of percutaneous tracheostomy, which can be completed by experienced personnel in approximately 2 minutes (17). This time gain with CBR may be beneficial in patients with severely compromised respiratory function, because ventilation patterns worsen during the period of bronchoscopy. Furthermore, discontinuation of the PEEP-level can be kept shorter. With regard to oxygenation, both CBR and PDT did not affect oxygenation variables in a significant manner; however, the drop of the oxygenation index (Pao2 divided by the Fio2) during tracheostomy was slightly less when PDT was performed, and Pao2 decreased. Short periods of intraoperative oxygen desaturation were noted in three patients.
In the PDT group, three threatening complications occurred intraoperatively in two patients. In particular, the posterior tracheal wall was perforated with one of the dilators in one patient. This could most likely be attributed to the unit of guidewire and guiding catheter kinked by 90° at the posterior tracheal wall, and the dilator was not directed in caudal direction within the tracheal lumen but went perpendicularly toward and subsequently through the posterior tracheal wall. This mechanism is in contrast to that demonstrated in another study, in which the guidewire kinked because of retraction of the guiding catheter into the dilator that reportedly resulted from insufficient stabilization of the guiding catheter during dilation (18). Regardless of the fact that dilation was achieved under bronchoscopic surveillance, the kinking of the guidewire/catheter unit remained undetected. Fortunately, our patient did not require surgical intervention and was uneventfully decannulated later during his hospital stay. In another patient, a pneumothorax was detected radiographically after uncomplicated PDT. Chest tube insertion resulted in immediate clinical improvement, and the follow-up was uneventful. Although bronchoscopic control during the tracheostomy procedure did not reveal any tracheal injury, a small tear in the posterior tracheal wall at the level of the puncture site was detected during airway inspection by an otorhinolaryngologist seven days after PDT.
During the course of cannulation, one complication was noted in a PDT patient. Within a few hours after elective change of the tracheostomy tube on Day 15 after PDT, the patient presented with considerable bleeding from the stoma’s wound edges. This was most likely caused by the 9.3-mm tube in place having been replaced by an 8.0-mm tube because reinsertion of a 9.3-mm tube was thought to be too difficult and traumatizing. However, the tight fit of the soft tissues and the tracheostomy tube was lost, and bleeding occurred. Reinsertion of a 9.3-mm tube was achieved without difficulties, however, and bleeding ceased spontaneously once the tracheostomy tube was in tight contact with the wound edges.
No severe complications were noted when CBR was performed. This is in accordance with results of the first 20 CBRs done by the authors (16). Nonetheless, the high incidence of fractures of single tracheal cartilage rings during insertion of the Blue Rhino dilator, which occurred in more than one third of the patients, remains a source of concern. As in our previous study in which tracheal ring fractures occurred in 5 of 20 patients (16), tracheal puncture and stoma dilation were performed in all 50 patients by the same team that had a formal experience of more than 300 previous percutaneous tracheostomies, including all techniques available. If these injuries had resulted from poor technique of puncture and dilation, a similar incidence of cartilage fractures would have been expected for both techniques. Therefore, the fractures during CBR can most likely be attributed to the rapid one-step dilation. Unexpectedly, the fractures did not occur at full insertion of the dilator but at approximately half way. In contrast, PDT cartilage fractures were bronchoscopically detected in only two patients. Pathology studies have demonstrated an incidence of damage to the tracheal cartilage rings during PDT ranging from 29% to 92% (19,20). Therefore, many of these injuries remain undetected on the basis of bronchoscopy alone. Although it is said that tracheal cartilage fractures after percutaneous tracheostomy rarely result in tracheal strictures or stenosis of clinical relevance after decannulation (19), further studies need to be done on this subject.
According to our data, CBR is a highly practicable technique for percutaneous tracheostomy. In contrast to PDT, CBR was free from major complications. However, to date, no data are available with regard to the long-term follow-up after decannulation. Prospective clinical trials have to be conducted before a definitive evaluation of CBR can be made.
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