Complications following the use of the Combitube, tracheal tube and laryngeal mask airway

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1 Complications following the use of the Combitube, tracheal tube and laryngeal mask airway W. Oczenski, 1 H. Krenn, 1 A. A. Dahaba, 2 M. Binder, 1 I. El-Schahawi-Kienzl, 3 S. Kohout, 4 S. Schwarz 5 and R. D. Fitzgerald 6 1 and 6 Consultants, 3 Resident and 5 Professor, Department of Anaesthesia and Intensive Care Medicine, and 4 Consultant, Department of Otolaryngology, City of Vienna Hospital Lainz, Wolkerbergenstraße 1, A-1130 Vienna, Austria 2 Research Fellow, 5 Director and 6 Research Director, Ludwig Boltzmann Institute for Economics of Medicine in Anaesthesia and Intensive Care Summary In a prospective, randomised trial, 75 patients scheduled for routine surgery were randomly allocated to one of three groups to evaluate trauma and postoperative complications after insertion of the Combitube, tracheal tube or laryngeal mask airway. Insertion of the Combitube was associated with a higher incidence of sore throat (48% vs. 16% vs. 12% [p < 0.01]) and dysphagia (68% vs. 12% vs. 8% [p < 0.01]) compared with tracheal intubation or insertion of the laryngeal mask airway, respectively. Hoarseness was significantly less common in both the Combitube and the laryngeal mask groups (both 12%) than in the tracheal tube group (44%; p < 0.01). Haematoma occurred in 36% of the Combitube group compared with 4% in both the laryngeal mask and the tracheal tube groups (p < 0.01). The higher incidence of complications should be considered when using the Combitube. Keywords Equipment; Combitube, laryngeal mask airway. Intubation, tracheal; complications.... Correspondence to: Dr W. Oczenski Accepted: 4 June 1999 Tracheal intubation is the standard method for maintaining a patent airway during anaesthesia. However, introduction of the tracheal tube usually requires direct laryngoscopy, which may cause laryngopharyngeal lesions leading to pain, sore throat and loss of voice, even after short-term intubation [1]. The oesophageal-tracheal Combitube (Kendall-Sheridan Catheter Corp., Argyle, NY, USA) is a well-established device in emergency medicine providing adequate ventilation and oxygenation without the need for direct laryngoscopy, with a low risk/benefit ratio [2 4]. Despite this advantage, the Combitube might cause trauma with its rather large blocking cuff, which, like that of the laryngeal mask airway (LMA), is inflated in the laryngopharyngeal region. The aim of this study was to evaluate trauma and postoperative complications after insertion of the Combitube compared with those following insertion of the LMA and tracheal tube. Methods The study was approved by our institutional ethics committee. All patients provided written, informed consent before inclusion. Patients with a history of difficult tracheal intubation and respiratory, cardiac, oesophageal or coagulation disorders were not studied as were patients with a 20% deviation from their ideal body weight. None of the female participants was pregnant. Seventy-five patients (20 65 years, ASA physical status 1 3) undergoing elective urological and gynaecological surgical procedures lasting 1 2 h were randomly allocated to one of three groups: Combitube group, tracheal tube group and LMA group. They were randomly assigned to one of four participating anaesthetists, all thoroughly experienced in handling the three devices. The laryngopharyngeal region of all patients was examined pre- and postoperatively on the day of operation by an otolaryngologist to 1161

2 W. Oczenski et al. Complications of the Combitube Anaesthesia, 1999, 54, pages evaluate mucosal redness, oedema, haematoma and mucosal laceration. Oral diazepam 10 mg was given 1 h before induction of anaesthesia, for premedication. Anaesthesia was induced with fentanyl 3 mg.kg ¹1 and propofol 2 3 mg.kg ¹1 intravenously until the eyelash reflex was lost, and maintained with mg.kg ¹1.min ¹1 propofol infusion, 60% nitrous oxide in oxygen, and fentanyl mg supplements if clinically required. Inspired oxygen concentration was adjusted to give a peripheral oxygen saturation above 95%. After induction of anaesthesia, rocuronium 600 mg.kg ¹1 was administered to all patients. Intubation/airway insertion was attempted 120 s after the beginning of injection of rocuronium. Duration of intubation/airway insertion was defined as the time from the start of intubation/airway insertion until inflation of the cuffs. All patients underwent volume controlled mechanical ventilation. In the Combitube group, a 37 FG Combitube was inserted blindly according to the recommended guidelines [5]: the lower jaw and tongue were lifted by one hand and the tube was inserted until the ring mark was placed opposite the teeth or alveolar ridges. The oropharyngeal balloon was inflated with 85 ml of air, and the distal balloon inflated with 12 ml of air. In the tracheal tube group, a high-volume low-pressure cuff tracheal tube (size 7.5 mm for women and 8.5 mm for men) was inserted following laryngoscopy using a size 3 Macintosh laryngoscope blade. Difficulty of intubation was graded I IV according to Cormack & Lehane [6]: Grade I (glottis fully visible), Grade II (glottis partially visible), Grade III (only the epiglottis visible) and Grade IV (only the soft palate visible). In the LMA group, an LMA was inserted blindly (size 3 for women, size 4 for men) according to the recommended instructions [7]: after putting the head into the sniffing position, the completely deflated and lubricated LMA was inserted into the mouth with the aperture of the mask facing the tongue and the back of the mask against the hard palate. The tube was guided by the index finger of the right hand over the back of the tongue, while the occiput was stabilised by the other hand. The tube was then advanced in one smooth movement until a characteristic resistance was felt, as the upper oesophageal sphincter was engaged. The cuff was inflated with 25 ml of air for size 3 and 35 ml for size 4 devices, which provided a good seal around the larynx. Insertion conditions of the Combitube/LMA were graded as excellent (no resistance to insertion), good (slight resistance to insertion), poor (moderate resistance to insertion) or impossible. If insertion was not possible, tracheal intubation was performed. Postoperative sore throat, dysphagia and hoarseness were graded as mild, moderate or severe by an otolaryngologist blinded to the group allocation of the patient. Statistical analysis Nominal data were compared by the Chi-squared test. The Kruskal Wallis test was used for intergroup comparisons of ordinal and non-normally distributed continuous data, followed by Wilcoxon Mann Whitney U-tests as appropriate. A value of p < 0.05 was considered statistically significant. Results No significant differences were detected among the three groups with respect to age, weight, gender and total fentanyl dose (Table 1). Gynaecological and urological patients were distributed evenly between the three groups. In the Combitube group, the Combitube was inserted in 12 patients (48%) without resistance; in nine patients (36%) with slight resistance; and in four patients (16%) with moderate resistance. The Combitube was in an oesophageal position in all patients. Two patients required two attempts and one patient required three attempts for successful insertion. In the tracheal tube group, 15 patients were classified as grade I, nine patients grade II and one patient grade III according to the criteria of Cormack & Lehane [6]. The tracheas of all patients were intubated without difficulty. In the LMA group, the LMA was easily inserted without resistance in 17 patients (68%) and with slight resistance in six patients (24%). One patient required two trials for successful insertion. In two patients (8%), the LMA could not be placed correctly, requiring tracheal intubation. These two patients were excluded from the study. CT LMA TT Age; years 45 (22 61) 50 (21 65) 45 (21 65) Male/female 6/19 10/13 5/20 Weight; kg 66 (40 87) 67 (50 102) 71 (51 94) Duration of intubation/airway insertion; s 25 (15 60) 15 (15 25)* 25 (15 60) Total fentanyl dose; mg 0.43 ( ) 0.41 ( ) 0.42 ( ) Table 1 Physical characteristics, duration of intubation/airway insertion and dose of fentanyl of patients receiving the Combitube (CT), tracheal tube (TT) or laryngeal mask airway (LMA). Data are shown as median (range) * p <

3 W. Oczenski et al. Complications of the Combitube Figure 1 Sore throat, dysphagia and hoarseness after insertion of the Combitube (CT), laryngeal mask airway (LMA) and tracheal tube (TT). *p < 0.01 compared with the other groups. Sore throat, dysphagia and haematoma occurred more often in the Combitube group than in the other groups, while hoarseness was more common in the tracheal tube group (Figs 1 and 2). In two patients (8%) of the Combitube group, sore throat was severe and in three patients (12%), dysphagia was severe. None of the patients in the tracheal tube or LMA groups suffered from severe sore throat or dysphagia. In five patients (20%) of the Combitube group, dysphagia lasted between 12 and 24 h, and in eight patients (32%) it lasted more than 24 h. In contrast, dysphagia lasted longer than 24 h in only one patient each (4%) of the LMA and tracheal tube groups. Figure 2 Mucosal redness, mucosal oedema, haematoma and mucosal laceration after insertion of the Combitube (CT), laryngeal mask airway (LMA) and tracheal tube (TT). *p < 0.01 compared with the other groups. 1163

4 W. Oczenski et al. Complications of the Combitube Anaesthesia, 1999, 54, pages Discussion The main finding of our study was that insertion of the Combitube was associated with a higher incidence of postoperative sore throat and dysphagia than tracheal intubation by direct laryngoscopy or insertion of the LMA. Furthermore, our data demonstrate that the traumatising effects on the pharyngeal mucosa caused by the Combitube were significantly greater than those of the tracheal tube or a LMA. In our study, the incidence of sore throat of 16% in the tracheal tube group is lower than those reported in previous studies of 22 48% depending on the size of tracheal tube used [8, 9]. The incidence of sore throat in the LMA group (12%) is similar to that reported by Brodrick [10] and slightly higher than the 6 8% reported by others [11, 12]. These data are comparable with the incidence of sore throat in anaesthetised unintubated patients [13]. The incidence of sore throat does appear to decrease with increased clinical experience in using the LMA [7]. Hoarseness occurred in 44% in the tracheal tube group, a slightly higher incidence than those reported in previous studies: 18 42% depending on the size of tracheal tube used [9, 14]. The low incidence of hoarseness (12%) in the Combitube and LMA groups might be related to the lack of contact made by both of these airway devices with the vocal cords. Tracheal intubation can result in haematoma, mucosal laceration, mucosal granuloma and arytenoid cartilage damage [1, 15, 16]. In our study, only one patient developed a haematoma following tracheal intubation, while the Combitube was more traumatising, resulting in haematoma in 36% and mucosal lacerations in 12% of patients. The higher incidence of postoperative dysphagia, sore throat, haematoma and mucosal lacerations after insertion of the Combitube compared with tracheal intubation by direct laryngoscopy or insertion of a LMA might be attributable to the pressure exerted on the anterior pharyngeal wall caused by the 85-ml pharyngeal cuff of the Combitube. The design of our study did not enable us to evaluate the incidence of postoperative complications using smaller volumes for the pharyngeal balloon or monitoring the intraballoon pressures. We conclude that because of the relatively high incidence of postoperative subjective discomfort and the pattern of traumatic lesions seen in our patients, blind insertion of the Combitube cannot be recommended for routine airway management, although, in contrast to the LMA, the Combitube protects from aspiration of gastric contents by its distal balloon [17]. Its use should be limited to emergency situations including unexpected difficult airway, failed tracheal intubation and perhaps difficult intubation when there is aspiration of gastric contents, upper airway bleeding or continued vomiting [4]. Acknowledgments We acknowledge the help of Mr K. Neumann for his valuable assistance in statistical evaluation. This study was supported by a grant of the Lord Mayor of Vienna Foundation for Medical Research (Grant #1617). References 1 Peppard SB, Dickens JH. Laryngeal injury following shortterm intubation. Annals of Otology, Rhinology, and Laryngology 1983; 92: Frass M, Frenzer R, Zdrahal F, Hoflehner G, Porges P, Lackner F. The esophageal tracheal Combitube: Preliminary results with a new airway for CPR. Annals of Emergency Medicine 1987; 16: Frass M, Frenzer R, Rauscha F, Weber H, Pacher R, Leithner C. Evaluation of the esophageal tracheal Combitube in cardiopulmonary resuscitation. Critical Care Medicine 1987; 15: Benumof JL. Management of the difficult adult airway. Anesthesiology 1991; 75: Frass M, Rödler S, Frenzer R, Ilias W, Leithner Ch, Lackner F. Esophageal tracheal combitube, endotracheal airway and mask: a comparison of ventilatory pressure curves. Journal of Trauma 1989; 29: Cormack RS, Lehane J. Diffcult tracheal intubation in obstetrics. Anaesthesia 1984; 39: Pennant JH, White PF. The laryngeal mask airway its uses in anesthesiology. Anesthesiology 1993; 79: Stock MC, Downs JB. Lubrication of tracheal tubes to prevent sore throat from intubation. Anesthesiology 1982; 57: Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anaesthesia. Anesthesiology 1987; 67: Brodrick PM, Webster NR, Nunn JF. The laryngeal mask airway. A study of 100 patients during spontaneous breathing. Anaesthesia 1989; 44: Brain AIJ, McGhee TD, McAteer EJ, Thomas A, Abu-Saad MAV, Bushman JA. The laryngeal mask airway: Development and preliminary trials of a new type of airway. Anaesthesia 1985; 40: Leach AB, Alexander CA. The Laryngeal Mask an overview. European Journal of Anaesthesiology 1991; Suppl. 4: Jensen PJ, Hommelgaard P, Söndergaard P, Eriksen S. Sore throat after operation: Influence of tracheal intubation, intracuff pressure and type of cuff. British Journal of Anaesthesia 1982; 54: Jones MW, Catling S, Evans E, Green DH, Green JR. 1164

5 W. Oczenski et al. Complications of the Combitube Hoarseness after tracheal intubation. Anaesthesia 1992; 47: Kambic V, Radsel Z. Intubation lesions of the larynx. British Journal of Anaesthesia 1978; 50: Schmidt WA, Schaap RN, Mortensen JD. Immediate mucosal effects of short-term, soft cuff, endotracheal intubation. Archives of Pathology and Laboratory Medicine 1979; 103: Frass M. The Combitube. Esophageal/tracheal double lumen airway. In: Benumof JL, ed. Airway Management Principles and Practice. St. Louis, USA: Mosby, 1996: