| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Anesthetic Protocol Both devices were lubricated with a water-based lubricant. Randomization to one of the airway devices (including anatomical fit and ETco2 subgroups) was based on computer-generated codes maintained in sequentially numbered opaque envelopes which were opened just before device insertion. Insertion of the device was attempted when the eyelash reflex had disappeared and the jaw was relaxed at least 60 sec after propofol administration. The LMAU was inserted with a partially inflated cuff. No muscle relaxants were administered before airway insertion.
LMAU and CobraPLA sizes were selected based on manufacturers recommendations, modified to avoid overlap of the weight groups. LMAU: Size 1 ( Failure to properly position an airway was defined by any one of the following: 1) inability to obtain an ETco2 waveform; 2) presence of an audible air leak at 10 cm H2O-peak inspiratory pressure; 3) an expired tidal volume <4 mL/kg; 4) signs of airway obstruction (peak airway pressure >25 cm H2O with low expired tidal volumes); or, 5) an Spo2 <93% with an Fio2 of 100%. If insertion failed, the following algorithm was pursued: (a) two attempts with the randomly assigned airway, (b) insertion of a smaller size study device; (c) a single insertion attempt with the alternative airway device; (d) 0.6 mg/kg IV rocuronium and tracheal intubation. The attending anesthesiologists were free to intubate the patients trachea at any time if clinically indicated.
Anesthesia was maintained with 60/40% N2O/O2, fentanyl ( Airway device insertion depth was defined by the distance from the tip of the device to a mark made at the level of the incisors after insertion. After device insertion, the patients head was maintained in neutral position by rolls positioned bilaterally. All devices were examined upon removal for gross blood staining. Perioperative complications such as laryngospasm and bronchospasm were recorded both intra and postoperatively.
Measurements Time for successful airway insertion was measured by an independent observer beginning when the tip of the device was at the level of the incisors and ending after all the following were completed: the cuff was inflated, the breathing circuit was connected to the airway, an ETco2trace was detected, a tidal volume of more than 4 mL/kg body weight was measured, and no air leak was detected at a peak inspiratory positive airway pressure ventilation of 15 cm H2O. The number of attempts, the initial airway size and the size ultimately used were recorded. Once the device was optimally positioned, it was taped and its position was not altered unless clinically necessary.
Ease of Insertion Airway sealing pressure was measured by closing the expiratory valve of the circle system at 3 L/min gas flow and recording the airway pressure at which the dial on the aneroid manometer reached equilibrium.11 Assessment of airway sealing pressure was initially performed with the devices cuff inflated to 60 cm H2O followed immediately by measurement at 40 cm H2O. Subsequently, the cuff was fully deflated, an orogastric tube (OGT) was passed into the stomach to remove any air that entered during the assessment period. The OGT was then removed and the devices cuff reinflated, monitored with a manometer (Mallinckrodt) and maintained at 40 cm H2O throughout the procedure. In a random subgroup of patients from both groups, a flexible fiberoptic bronchoscope (Olympus BFP 30, O.D. 5.0 mm, Tokyo, Japan) was inserted through the device via a connector with a self-sealing diaphragm up to the mask aperture bars both before and at the end of the surgery. The airway position was scored as follows12: 4 = only vocal cords visible; 3 = vocal cords plus posterior epiglottis visible; 2 = vocal cords plus anterior epiglottis visible; 1 = vocal cords not fiberoptically visible. At the end of surgery with the patient deeply anesthetized, the cuff of the device was deflated, an OGT was inserted under direct vision using a tong blade depressor and gas was aspirated from the stomach using a 60-mL syringe.13 The amount of gas aspirated was recorded for each device. The position of the OGT was confirmed by the presence of gastric content at aspiration. If nothing was aspirated, 2 mL of air was injected while listening over the epigastrium to confirm the tubes position and clear any blockage. These 2 mL of air were then aspirated and omitted from calculations. Difficulties with the OGT insertion, if any, were noted. The oral cavity and part of the pharynx were inspected for blood or trauma before and after the placement of the OGT. One and 24 h postoperatively, the patients parents (blinded to group assignment) were asked to rate the presence of dysphonia (Yes/No). Sore throat was assessed as present or absent (when age and willingness allowed the patients to respond) 1 h postoperatively. A specially designed CobraPLA prototype with an ETco2 sampling site (Fig. 1) that opened at the head of the device was used in a subset of patients. Once steady-state was reached (10–15 min postinduction) both head and Y-piece ETco2 and ETsevo were recorded every 15 min.
Statistical Analysis
Morphometric and anesthetic data were analyzed using Students t-test. The numbers of failed device insertions were compared with a Fishers exact test. For the major outcomes, the patients in the two groups were subdivided post hoc into four groups: small CobraPLA (CobraPLA sizes 0.5 and 1), small LMAU (LMAU sizes 1 and 1.5), large Cobra PLA (CobraPLA sizes 1.5 and 2), and large LMAU (LMAU sizes 2 and 2.5). Analysis of variance was used for continuous measurements and Differences in anatomical fit between the CobraPLA group and LMAU group immediately after induction of anesthesia and before emergence were analyzed using Wilcoxon Signed Rank Test. The ET (co2 and sevo) at head and Y-piece were compared with linear regression and Bland Altman statistics. Results are presented as means ± sds; P < 0.05 was considered significant. RESULTS There were no significant differences with regard to morphometric or anesthetic data (Table 1), except that the surgery and, hence anesthesia, lasted longer in the patients who received the CobraPLA: 62 ± 32 vs 50 ± 27 min, P = 0.006. First-attempt device insertion was successful in 95% of patients with a CobraPLA, and in 96% with an LMAU. However, the cumulative insertion success rate increased to 99% for both devices after the second attempt. Four patients in the CobraPLA group and three in the LMAU group required two attempts at insertion. One patient in each group required three attempts at insertion.
Major Outcomes
Anatomical fit was assessed in 33 CobraPLA patients and 30 LMAU patients. The fiberoptic view was significantly better (scores 3–4) in the CobraPLA group than in the LMAU group both immediately after induction and before emergence (P < 0.001). The overall fit was judged worse before emergence than after induction in the LMAU subgroups (scores 1–2) as compared with the CobraPLA subgroups in which there was no change (Table 2). This suggests that CobraPLA was more stable in the airway than the LMAU. The fiberoptic examination revealed no epiglottic down-folding or laryngeal view obstruction in the CobraPLA group, whereas in the LMAU group epiglottic down-folding and laryngeal view obstruction occurred in two patients after induction and in six patients before emergence. The airway sealing pressure at a cuff inflation pressure of 40 cm H2O in the large CobraPLA subgroup (18 ± 6 cm H2O) was more than that of the small PLA (15 ± 4 cm H2O) and the large LMAU subgroups (15 ± 5 cm H2O, P = 0.003). The airway sealing at a cuff inflation pressure of 60 cm H2O in the large CobraPLA subgroup (22 ± 7 cm H2O) was also significantly more than that of the small PLA subgroup (18 ± 5 cm H2O) and the large LMAU subgroup (16 ± 5 cm H2O; P < 0.001) (Fig. 2). In contrast, at inflation pressures of both 40 and 60 cm H2O, the airway sealing pressures were similar in the small and large LMAU groups. The peak airway pressure at 20 min was significantly smaller in the large LMAU subgroup than in any of the other three subgroups (Table 2).
The incidences of complications (laryngospasm, bronchospasm, blood staining on the device, sore throat, and dysphagia) were similar in the four subgroups. The volume of stomach gas aspirated was significantly smaller (P < 0.001) in patients having a CobraPLA (0.6 mL/kg) than in those given a LMAU (1.3 mL/kg). In addition, children in the large LMAU subgroup had a larger stomach gas volume than did children in the other subgroups (Table 2). There was neither difficulty nor apparent trauma with the OGT placement. In two patients in each device group (one each with the CobraPLA 1 and 1.5, LMAU 1 and 1.5) placement of the device failed due to either laryngospasm or bronchospasm. Three of the patients tracheas were intubated after the second attempt at placing the extraglottic device. In one case, the patients trachea was intubated only after three failed insertion attempts with the assigned device (LMAU) and an additional failed attempt with a CobraPLA. None of these four patients had any additional complications.
Ventilation Linear regression and the Bland Altman plot for ETco2 are presented in Figures 3 and 4. Linear regression between the measurement sites for ETco2 indicated that the values at the Y-piece site were more than that at the head site (Proximal measurement = 0.8 [head measurement] + 3, r = 0.75). The head values were 6.4 ± 6 cm H2O more than those of the Y-piece site. Linear regression between weight and the ETCO2 differences at the CobraPLA head and the Y-piece peace are presented in Figure 5. We found that substantial differences between ETCO2 concentrations at the Cobra PLAs head and the circuit Y-piece occurred in children up to at least 30 kg.
Linear regression indicated that the sevoflurane concentrations at the Y-piece and head measurement sites were essentially equal (Y-piece measurement = 0.9 [head measurement] + 0.2, r = 0.88). The mean bias was –0.03 ± 0.32. DISCUSSION Our results show that the CobraPLA airway performs as well as the LMAU Classic during anesthesia in pediatric patients for a large range of outcomes and out-performed the LMAU for others. We could only partially confirm previous reports in adults that the CobraPLA provides superior sealing pressures to LMAU during controlled ventilation.6,14 Overall, there were no significant differences between the sealing pressures in the two airway groups at 40 or 60 cm H2O; however, subgroup analysis revealed that the sealing pressures in the large CobraPLA subgroups (1.5 and 2) were more than those of the small CobraPLA subgroup (0.5 and 1) and the large LMAU subgroup (2 and 2.5) at both inflation pressures. The lack of an increased sealing pressure in pediatric patients receiving the small CobraPLA sizes might have been the result of a difference in the anatomical shape of the pharynx in infants versus older children and adults. In fact, Arens et al.15 assessed the airway dimensions of children aged 1 to 11 yr by magnetic resonance imaging and found a linear increase in the upper airway dimensions with age. They concluded that soft tissues surrounding the upper airway, including tonsils and adenoids, grow proportionally to the skeletal structures. Sealing pressures were measured at two different cuff inflation pressures: 40 and 60 cm H2O. In adults 70 cm H2O (range, 51–92) intracuff pressure in a cuffed oropharyngeal airway generated a mucosal pressure of 56 cm H2O (range, 22–87). With increased intracuff pressure, mucosal blood flow decreases progressively until it is abolished at mucosal pressures more than 80 cm H2O.16 The 60 cm H2O inflation pressure is, however, higher than the mean arterial blood pressure of children and infants, and thus we selected a second lower cuff inflation pressure below this range (40 cm H2O). No data are available on the optimal cuff pressure to preserve pharyngeal mucosal blood flow in infants and children. We assumed that if sealing were effective at 40 cm H2O the side effects of higher inflation pressures (e.g., sore throat) would be minimized. The sealing pressures at 40 and 60 cm H2O cuff inflation were similar. Age is often reported as a risk factor for complications during pediatric anesthesia.17 In a survey of 9289 anesthetics in patients younger than 62 mo, the incidence of airway complications were related to age.18 Our study was not powered to confirm these results, especially as complications other than sore throat and dysphonia were uncommon. LMAU use in infants has been limited due to the relatively frequent incidence of airway complications associated with the size 1 LMAU.19–21 One study found a 22% incidence of airway complications when the LMAU 1 was used.20 Bagshaw22 reported a complication rate of 42% with the use of a size 1.5 LMAU with complications more common in younger patients. Positioning the size 1 LMAU was also found to be difficult and resulted in respiratory complications in 30% of the patients.17 In 6% of patients, the device functioned inadequately with insertion followed by delayed airway obstruction in 24% of children.16 Others report similar difficulties with small sizes of LMAUs.23 These problems resulted from distortion of the airway with epiglottic down-folding that might have contributed to the partial upper airway obstruction.17 Once in place, accidental dislodgement of the LMAU can occur, but this is considered a minor complication if the patients airway is accessible.23 Distortion of the LMAU by epiglottic down-folding occurs in as many as 90% of children after the insertion of sizes 2 and 2.5 LMAUs; this might contribute to partial upper airway obstruction.17,24 Usually, this does not affect the devices functionality with spontaneous breathing but it can cause difficulties with positive pressure ventilation and it may hamper intubation through an LMAU. Epiglottic folding causing partial or complete obstruction was also found in 77% of patients 10 kg and undermanaged with CobraPLA.25 In marked contrast, we did not observe laryngeal view obstruction by the epiglottis in the CobraPLA group. In the LMAU group, however, there were two cases with epiglottis down-folding after induction and six before emergence, which indicated the tendency for the position of LMAU to shift during anesthesia. As in other studies this shift in LMAU position did not seriously affect ventilation.17 The success rate at first and second attempts was more than 95% and 99% respectively with both airways. This contrasts with earlier reports of a 90%26 and 86%24 success rate for LMAU placement at first attempt with only a 97% success rate by the third attempt. The fit and sealing characteristics of CobraPLA (1.5 and 2) in mechanically ventilated children were found adequate in 90% of cases at the first attempt and 97.5% at the second attempt.27 We found the CobraPLA to be more stable than the LMAU. The apparent stability of the CobraPLA can be attributed to its wide, flat distal head, which is rigid enough to prevent rotation of the device. The better anatomical fit of the CobraPLA becomes especially important if fiberoptic intubation through the device is needed.8,10 Distension of the stomach can lead to pulmonary embarrassment by splinting the diaphragm and could predispose reflux and pulmonary aspiration of gastric contents. The incidence of gastroesophageal insufflation during use of the LMAU, assessed qualitatively, depends on airway pressure and is reported to range from 0%28 to 35%.29 In a previous study, LMAU malposition increased the chance of gastric insufflation from 3% to 19%.30 Our CobraPLA patients had less gastric volume than those in the LMAU group which may have related to a better anatomical fit with the CobraPLA. Nitrous oxide was administered at the same concentration in all patients, and its influence on cuff pressure was limited by monitoring and maintaining cuff pressure at 40 mm Hg. Nonetheless, patients in the CobraPLA group had a slightly longer anesthesia time and less gastric distention than the LMAU group. A limitation is that we measured gastric volume by OGT aspiration. Although gastric volume has been measured this way in previous studies,23,31 the method can be inaccurate. Gastric volume can be qualitatively assessed by epigastric auscultation,32–34 since as little as 5 mL of gas entering the stomach can be detected by this method.35 In one study, for children managed with a LMAU, the stomach gas volume measured by auscultation was reportedly lower (0.22 ± 0.25 mL/kg)26 than in our patients (1.3 mL/kg). This difference may have been that we aspirated the stomach after we performed the airway sealing measurements and then removed the OGT; at the end of anesthesia we reinserted the OGT. Our measured gas volume thus reflected the gas volume leaked into the stomach during surgery. In contrast, an OGT left in situ, as in previous studies, may allow some air to escape around it. Previous work suggests that the small tidal volumes in infants make ETco2 measurements at the Y-piece piece of the circle system inaccurate compared with measurements at the end of an endotracheal tube.36 Our results support this assertion, as values were greater (and presumably more accurate) at the head of the CobraPLA. The difference was 6.4 ± 6 mm Hg which could be clinically important. The substantial differences found between ETCO2 concentrations at the Cobra PLAs head and the circuit Y-piece in children up to 30 kg suggest that CobraPLA head gas sampling is potentially beneficial in most pediatric patients, not just infants. It remains unclear whether this difference results only from increased dead-space or if a leak around the CobraPLA may have also contributed. In summary, the CobraPLA performed as well as the LMAU Classic during anesthesia in infants and children but proved superior with regards to the anatomical fit and stability within the airway. The CobraPLA also produced less gastric insufflation. In infants, the distal site sampling of ETco2 with the CobraPLA may be more accurate than the standard measurement site at the Y-piece piece of the anesthesia circuit. ACKNOWLEDGMENTS The authors thank Gil Haugh, MS, from the University of Louisville, KY, for his assistance with the statistical analysis.
Footnotes Accepted for publication June 18, 2008. Supported by Engineered Medical Systems, Indianapolis, IN Grant HSC-MS-03-073. Dr. Sesslers time was supported by the Joseph Drown Foundation (Los Angeles, CA). The sponsor was not involved in study design, data collection or analysis, nor manuscript preparation. Presented, in part, at the American Society of Anesthesiologists Meeting, Chicago, IL, October 14–18, 2006; American Society of Anesthesiologists Meeting, New Orleans, LA/Atlanta, GA, 2005; and IARS 79th Clinical and Scientific Congress, Honolulu, HI, March 11–15, 2005. REFERENCES
This article has been cited by other articles:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|