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In a prospective, randomized, and controlled trial, we compared the stress responses after insertion of the Combitube® (CT; Kendall-Sheridan Catheter Corp., Argyle, NY), the laryngeal mask airway (LMA), or endotracheal intubation (ET). Seventy-five patients scheduled for routine urological or gynecological surgery were randomly allocated to one of three groups and were ventilated via either an ET, a LMA, or a CT. All three devices could be inserted easily and rapidly, providing adequate ventilation and oxygenation. Insertion of the CT was associated with a significant increase in mean maximal systolic arterial pressure (160 ± 32 mm Hg) and diastolic arterial pressure (91 ± 17 mm Hg) compared with ET (140 ± 24, 78 ± 11 mm Hg; P < 0.05, P < 0.01, respectively) or insertion of the LMA (115 ± 33, 63 ± 22 mm Hg, both P < 0.001). The mean maximal epinephrine and norepinephrine plasma concentrations after insertion of the CT (37.3 ± 31.1 and 279 ± 139 pg/mL, respectively) were significantly higher than those after ET (35.8 ± 89.8 and 195 ± 58 pg/mL, respectively) or insertion of a LMA (17.3 ± 13.3 and 158 ± 67 pg/mL, respectively). This might be attributed to the pressure of the pharyngeal cuff of the CT on the anterior pharyngeal wall. We conclude that insertion of the CT causes a pronounced stress response and that precautions should be taken when used in patients at risk of hypertensive bleeding. Implications: In this study, we showed that the hemodynamic and catecholamine stress responses after insertion of the Combitube® (Kendall-Sheridan Catheter Corp., Argyle, NY) were significantly higher compared with laryngeal mask airway or endotracheal intubation. We conclude that the increased stress response to insertion of a Combitube® may represent a serious hazard to patients with cardiovascular disease.
Hypertension is a hazard for certain groups of emergency patients, e.g., those with subarachnoidal bleeding or aortic dissection. Thus, stress induced while securing the airway of these patients should be minimized. For emergencies and cardiopulmonary resuscitation, the esophageal-tracheal Combitube® (CT; Kendall-Sheridan Catheter Corp., Argyle, NY) has been introduced as an effective technique, providing adequate oxygenation and ventilation with a low risk/benefit ratio (14). Despite its widespread use, little is known about hemodynamic and catecholamine stress responses after insertion of the CT. Thus, in a prospective, randomized trial, we investigated and compared the hemodynamic and catecholamine stress responses after insertion of the CT with that after endotracheal intubation (ET) and insertion of a laryngeal mask airway (LMA). We hypothesized that insertion of the CT elicits higher serum levels of epinephrine and norepinephrine and a more pronounced hemodynamic reaction than the two other methods.
The study was approved by our institutional ethics committee, and patients provided written, informed consent before inclusion. Exclusion criteria were a history of difficult ET, respiratory, cardiac or esophageal disease, and coagulation disorders. We also excluded patients with a 20% deviation from their ideal body weight. The laryngo-pharyngeal region was examined preoperatively and graded according to Samsoon and Young's (5) modification of the Mallampati test. Seventy-five patients (2065 yr, ASA physical status IIII) undergoing elective urological and gynecological surgical procedures (duration 12 h) were randomly allocated to one of three groups: ET group, LMA group, and CT group. They were randomly assigned to one of four participating anesthetists thoroughly experienced in handling all three devices. After premedication with diazepam 10 mg per os, anesthesia was induced with fentanyl 3 µg/kg and propofol 23 mg/kg IV until loss of eyelash reflex, and anesthesia was maintained with a 50- to 100-µg · kg-1 · min-1 propofol infusion, 60% nitrous oxide in oxygen, and supplements of fentanyl 50100 µg if clinically required. Hemodynamic variables were monitored invasively via a radial artery cannula. Rocuronium 600 µg/kg was administered for ET and/or mechanical ventilation via the LMA or the CT. 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. Difficulty of intubation was graded IIV according to the criteria of Cormack and Lehane (6). Intubation of the trachea was attempted with endotracheal tubes, size 7.5 for women and 8.5 for men. Women were ventilated via a LMA size 3, men via a LMA size 4. The LMA was inserted blindly according the recommended instructions (7). The cuff was inflated with 25 mL of air for size 3 and 35 mL of air for size 4 devices. All patients in the CT group were ventilated via a CT size SA 37F according to the recommended guidelines (8). The oropharyngeal balloon was inflated with 85 mL of air, and the distal balloon was inflated with 12 mL of air. Insertion conditions of the LMA or CT were graded according to ease of insertion: excellent (no resistance to insertion), good (slight resistance to insertion), poor (moderate resistance to insertion), or impossible. If insertion was not possible, the patients were intubated endotracheally. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), and heart rate (HR) were recorded immediately before and 1, 2, 3, 5, 7, 10, and 15 min after intubation/airway insertion; and immediately before and 1, 3, and 5 min after extubation/airway removal. SaO2, end-tidal CO2, PaO2, PaCO2, pH, and peak airway pressures were recorded. Arterial blood samples for determination of catecholamine levels were drawn after the induction of anesthesia, immediately before and 1, 5, and 10 min after intubation/airway insertion (before skin incision); and 1 min after extubation/airway removal. The blood samples were collected in precooled (28°C) tubes containing EDTA and reduced glutathione. The samples were immediately centrifuged at 0°C. All samples were analyzed in duplicate using liquid chromatography and electrochemical detection (Beckman, Palo Alto, CA). Interassay variation was 5.4% for epinephrine and 6.4% for norepinephrine.
The Kruskal-Wallis test was used for intergroup comparisons. Multiple Mann-Whitney U-tests were used for nonparametric data comparisons, in which the
No significant differences were detected among the three groups with respect to age, weight, gender, total fentanyl dose, and Mallampati score (Table 1). Insertion time was significantly shorter in the LMA group (P < 0.01). No supplemental dose of fentanyl was administered during the intubation/insertion procedure until the end of the 15-min observation period. Gynecological and urological patients were distributed evenly among the groups.
In the ET group, 15 patients were as classified grade I, 9 patients were grade II, and 1 patient was grade III according to the criteria of Cormack and Lehane (6). The tracheas of all patients were intubated without difficulty. The LMA was easily inserted without resistance in 17 patients (68%), with slight resistance in 6 patients (24%). One patient required two trials for insertion. In two patients (8%), the LMA could not be placed, and required intubation. These patients were excluded from the study. The CT was inserted in 12 patients (48%) without resistance, in 9 patients (36%) with slight resistance, and in 4 patients (16%) with moderate resistance. The CT was in an esophageal position in all patients. Two patients required two attempts, and one patient required three attempts for successful insertion. In the CT and ET groups (Figs. 1 and 2), significant increases in HR, SAP, DAP, and MAP (P < 0.01) were detected from 1 to 10 min compared with baseline values. After LMA insertion, no significant increase in HR occurred, whereas SAP, DAP, and MAP slightly increased at 1 min (P < 0.05).
The increases in HR (P < 0.001), SAP, DAP, and MAP (P < 0.01) were significantly greater in the CT and ET groups compared with the LMA group. Insertion of the CT was associated with a significant increase in mean maximal SAP (160 ± 32 mm Hg), DAP (91 ± 17 mm Hg), and MAP (114 ± 20.7 mm Hg) compared with ET (140 ± 24, 78 ± 11, 99 ± 13.7 mm Hg; P < 0.05) or LMA (115 ± 33, 63 ± 22, 80 ± 25.1 mm Hg; P < 0.001). All three groups showed a significant increase in HR (P < 0.05), SAP, DAP, and MAP (P < 0.01) 1, 3, and 5 min after extubation/airway removal. No significant differences were detected among the groups. Plasma catecholamine levels are shown in Table 2 and 3.
Mean maximal inspiratory peak pressures were significantly higher in the CT group (21.3 ± 4.7 mm Hg) compared with the ET group (13.2 ± 2.5 mm Hg; P < 0.001) and the LMA group (13.7 ± 2.9 mm Hg; P < 0.001). No significant difference or irregularity in any variable for ventilation or oxygenation was detected.
In our study, insertion of the CT was associated with a significantly higher and longer lasting increase in SAP, DAP, MAP, HR, and plasma catecholamine concentrations compared with insertion of the LMA or ET. Based on the literature, we anticipated that the insertion of a LMA would elicit a much smaller hemodynamic and catecholamine response than tracheal intubation (9,10). However, it was not clear that using a CT was more stressful than ET as direct laryngoscopy is avoided. Moreover, blind insertion of a CT most often results in an esophageal position, thus resembling the insertion of a LMA. Differentiating the effects of laryngoscopy and ET, Shribman et al. (11) concluded that the major cause of the sympathoadrenal response to tracheal intubation arises from stimulation of the supraglottic region by tissue irritation induced by direct laryngoscopy. Insertion of the tube through the vocal cords and inflation of the cuff in the infraglottic region should contribute very little additional stimulation. Hassan et al. (12) reported that, by activating proprioceptors, direct laryngoscopy induces arterial hypertension, tachycardia, and increased catecholamine concentrations proportional to the intensity of the stimulus exerted against the base of the tongue. However, subsequent tracheal intubation should stimulate additional receptors in the larynx and the trachea, thus enhancing the hemodynamic and epinephrine response (13). In our study placement of the CT was always esophageal. Thus, we attribute our findings to a higher mechanical pressure on the tissues of the anterior pharyngeal region, possibly by the 85-mL cuff of the CT and the irritation of the esophagus by the insertion of the device and subsequent inflation of the smaller blocking balloon. The unequal hemodynamic and catecholamine stress reaction between CT and ET was not a result of a difference in the time necessary for insertion of the CT versus ET. This is important to note, as Stoelting et al. (14) demonstrated that the time required for performing ET directly correlates with an increase in MAP. Hemodynamic and catecholamine responses to insertion of the LMA were minimal, which supports the findings of Wilson et al. (10), who reported that the cardiovascular responses induced by laryngoscopy and intubation were more than twice as high as those produced by the insertion of a LMA. Our data contradict the results of Braude et al. (15) and Griffin et al. (16), who found no significant difference in pressure response after insertion of a LMA and ET. After extubation/airway removal, the hemodynamic and plasma catecholamine concentrations reached their highest levels in all three groups. Compared with the LMA, norepinephrine concentrations were significantly higher after removal of the CT, whereas those in ET patients were not statistically different from those in either group. Our results are in accordance with the findings of Fujii et al. (17), who showed that removal of the LMA is associated with fewer cardiovascular changes than tracheal extubation in normotensive and hypertensive patients. In contrast to our data, Lowrie et al. (18) demonstrated an absence of norepinephrine response after endotracheal extubation, from which they concluded that the extubation had less effect than tracheal intubation and laryngoscopy. However, the stress reaction seen in our plasma catecholamine levels correlates well to the clinically evident arousal seen in the patients during the extubation/airway removal procedure. Frass et al. (19) reported a significantly higher mean PaO2 during ventilation via a CT compared with an ET. This was attributed to a prolonged expiratory flow time and the occurrence of a small positive end-expiratory pressure as a result of an increase in expiratory resistance caused by the double-lumen design of the CT and integration of the vocal cords into the airway. The increase in expiratory resistance is a function of the reduced total cross-sectional area of the CT holes, which may, on occasion, be further reduced by the collapse of surrounding pharyngeal tissue during expiration. An increase in laryngeal tone may also contribute to flow resistance; in extreme cases, overzealous inflation of the esophageal balloon may even compress the posterior tracheal wall. However, in our study there was no significant difference in PaO2 and PaCO2 among the study groups. We found significantly higher inspiratory peak pressures in the CT group than in the other two groups. Inspiratory peak pressure is an artifact of its site of measurement at the airway opening attributable to the resistance of the double-lumen airway already reported by Frass et al. (19). Intratracheal pressures with a CT or ET were in the same range, with similar degrees of lung inflation, when measured by a catheter placed below the vocal cords (19). The increased hypertensive response to insertion of the CT may represent a serious hazard to patients with cardiovascular or cerebrovascular disease, e.g., aortic dissection or subarachnoidal bleeding. Because stress during the induction of anesthesia is a major factor in myocardial ischemia, caution should be applied when using the CT in patients with cardiac risk, as the release of endogenous catecholamines increases myocardial oxygen demand. If insertion of the CT is considered, effective measures should be implemented to minimize the stress responses. The main indication for the CT is the unexpected difficult airway, failed tracheal intubation, and perhaps the inability to visualize the vocal cords in a patient at risk of aspiration of gastric contents, e.g., upper airway bleeding or continued vomiting.
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