CLINICAL TRIAL

Endotracheal Intubation Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children Michael A. Acquaviva, Nicole D. Horn, and Sandeep K. Gupta ABSTRACT Objectives: The present study examined the safety and efficacy of a laryngeal mask airway (LMA), compared with an endotracheal tube (ETT), for children undergoing elective esophagogastroduodenoscopy (EGD). Methods: A total of 84 American Society of Anesthesiologists (ASA) patients, status I to III, were randomly assigned to receive an ETT or LMA. All participants were premedicated with midazolam 0.5 mg/kg (up to 15 mg). Airway device placement occurred after induction with 8% sevoflurane and 100% oxygen, placement of an intravenous catheter, and intravenous lidocaine 2 mg/kg up to 100 mg. The following data were collected: time from induction of anesthesia to placement of the airway device, time from end of procedure to arrival in the postoperative acute care unit (PACU), time in the PACU, time from arrival in the operating room (OR) to discharge, vomiting after the procedure, nausea requiring medicine, lowest oxygen saturation, highest concentration of sevoflurane, highest pain, amount of pain medicine, adverse events, and satisfaction of doctor performing the EGD. Results: Group ETT had higher time from room arrival to airway placement, mask to airway placement, room arrival time to discharge, mask placement to discharge, airway placement to discharge, and end of procedure to discharge. Group ETT had a higher proportion of patients with vomiting than group LMA. No statistical difference was noted in endoscopist satisfaction when comparing ETT and LMA. The ETT group had 3 adverse events, including laryngospasm (n ¼ 2) and asthma attack (n ¼ 1). Conclusions: The LMA appears to be an acceptable and safe alternative for otherwise healthy children undergoing routine EGD. Benefits appear to be decreased incidence of vomiting and overall decreased time spent in the hospital. Key Words: children, endotracheal tube, esophagogastroduodenoscopy, laryngeal mask airway

(JPGN 2014;59: 54–56)

E

sophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or without associated biopsies, is relatively short in length. Unlike adults, who regularly undergo this procedure with conscious

Received and accepted February 15, 2014. From the Riley Hospital for Children at IU Health, Indianapolis, IN. Address correspondence and reprint requests to Michael A. Acquaviva, Pediatric Anesthesia, Riley Hospital for Children at IU Health, 705 Riley Hospital Dr, Suite 2001, Indianapolis, IN 46202-5200 (e-mail: [email protected]). www.clinicaltrials.gov registration number: NCT01936662. The authors report no conflicts of interest. Copyright # 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition DOI: 10.1097/MPG.0000000000000348

sedation, children mostly require general anesthesia (1). Minimal literature exists as to what type of sedation is adequate and safe for children during EGDs. At resident teaching facilities, where experience among endoscopists and anesthesia residents varies, general anesthesia may be the preferred choice of sedation. Although safe and effective, tracheal intubation of children for EGD can result in delayed awakening and slow room turnover, particularly when intravenous medications are required for intubation (2). Laryngeal mask airway (LMA) is an alternative to intubation, which permits removal before full awakening (3). Although considered a safe alternative to tracheal intubation in appropriate patients, disadvantages of the LMA have been reported including kinking, occluding view of the surgical field, failure of placement requiring tracheal intubation, aspiration of gastric contents, desaturation, and laryngospasm (3–6). The study was designed to determine whether use of an LMA for EGD could reduce operating room (OR) time, while providing satisfactory conditions for the endoscopist, and an equivalent adverse effect and safety profile compared with an endotracheal tube (ETT) in otherwise healthy children with gastrointestinal complaints.

METHODS After obtaining approval from the institutional review board, 84 pediatric patients, ages 3 to 17 years, American Society of Anesthesiologists (ASA) status I to III (correlating with healthy children through those with severe systemic illness), undergoing elective EGD with or without biopsies under general anesthesia were considered eligible for the study. Based on a sample size of 42 patients per group, the study was powered at 80% to detect a difference in 15 minutes, assuming the data are lognormally distributed and a ¼ 0.05 with coefficient of variation equal to 0.255. Written informed consent was obtained from the parent/legal guardian, and, if appropriate, written informed assent was obtained from the patient. Exclusion criteria included the following: abnormal or difficult airway; symptomatic obstructive sleep apnea; high aspiration risk of stomach contents; upper respiratory infection within last 14 days; allergy to lidocaine, ondansetron, or midazolam; EGD procedure associated with the need to exclude ondansetron administration; body mass index >85th percentile for age; inability to communicate effectively with study personnel; positive urine pregnancy test (only menstruating girls at screening). Patients were randomly assigned after a nonstudy participant removed a number from a secure manila envelope. Premedication with 0.5 mg/kg oral midazolam (up to 15 mg) occurred 15 to 30 minutes before the procedure. In the OR, standard ASA monitors were applied. General anesthesia was induced with a semiclosed anesthetic circuit primed with 8% sevoflurane and 100% oxygen. After inhalational induction, an intravenous catheter was placed. Lactated Ringer’s infusion was started at a predetermined rate followed by the administration of intravenous lidocaine 2 mg/kg up to 100 mg. After 1 minute, the selected airway device

54 JPGN  Volume 59, Number 1, July 2014 Copyright 2014 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.

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Volume 59, Number 1, July 2014

was placed. Immediately after airway device placement, 0.1 mg/kg of intravenous ondansetron (up to 4 mg) was administered. The airway device was considered secure once a positive capnographic waveform was obtained with either a spontaneous respiration or bag ventilation, in conjunction with bilateral breath sounds and adequate chest rise. The airway device was attached to the anesthetic circuit and anesthesia was maintained at 1.5 to 2.0 minimum alveolar concentration. For reference, 1.0 minimum alveolar concentration is the anesthetic depth at which 50% of patients would move following a surgical incision. After placing the patient in lateral decubitus position for the procedure, the endoscopist placed the endoscope in the mouth and advanced while advising the anesthesiologist if jaw thrust or deflation of LMA cuff was needed for placement, and returned supine when the EGD concluded. Once the procedure was complete, LMAs were removed in a deep anesthetic state and ETTs were removed when the patient met standard extubation criteria (return of airway reflexes, grimace, and regular spontaneous respirations). The following data were collected: time from induction of anesthesia to placement of the airway device, time from end of EGD to arrival in the postoperative acute care unit (PACU), time spent in the PACU, overall time from arrival in the OR to discharge home, vomiting after the procedure, nausea requiring medicine after the procedure, lowest oxygen saturation level during or after the procedure, highest concentration of sevoflurane during the procedure, highest pain level after the procedure, amount of pain medicine given, adverse events, and satisfaction level of the doctor performing the EGD. The endoscopist used the following satisfaction scale for each patient, regardless of the airway device used: 1. The airway device did not interfere at all with the ability to perform the scope. 2. The airway device presented some interference with the scope, but not enough to cause difficulty. 3. The airway device made it difficult to perform the endoscopy. 4. The airway device prevented the endoscopy from being performed. The primary outcome of the study was a difference in time to discharge between the LMA group and the ETT group. The 2 groups were compared for differences in vomiting, nausea, pain medicine given, and adverse events using x2 tests. Wilcoxon rank sum tests were used to compare the groups for differences in times during the procedure, lowest saturation, highest sevoflurane concentration, highest pain score, and endoscopist satisfaction.

RESULTS Data from 84 patients were analyzed. Baseline patient characteristics are shown in Table 1. In the 2 study groups, the EGD itself had an average duration of 16 minutes, with the LMA group averaging 16.3 minutes and the ETT group 16.5 minutes. Cardiovascular and respiratory indicators remained within normal ranges and did not differ among study groups. All anesthetics were administered or staffed by fellowship-trained pediatric anesthesiologists. Of the 84 anesthetics, 5 were performed without resident participation, 46 by pediatric anesthesia fellows, 5 by third-year anesthesia residents, 20 by second-year anesthesia residents, and 8 by first-year anesthesia residents. The ASA status of all participants was binomially distributed. A total of 18 patients were ASA class 1 (normal healthy patients), 49 were ASA class 2 (patients with mild systemic disease), and 17 were ASA class 3 (patients with severe systemic disease). Among the study arms, the ETT group had 10 ASA class 1, 24 ASA class 2, and 8 ASA class 3. The LMA group had 8 ASA class 1, 25 ASA class 2, and 9 ASA class 3. www.jpgn.org

Endotracheal Intubation Versus LMA for EGD in Children TABLE 1. Clinical characteristics of patients Group LMA (n ¼ 42)

Group ETT (n ¼ 42)

10.4  6.2 32.6  12.8 20:22

10.1  4.2 38.5  17.3 20:22

Age, y Weight, kg Sex (male:female)

Values are mean  standard deviation or numbers. ETT ¼ endotracheal tube; LMA ¼ laryngeal mask airway.

The only statistically significant complication noted was a higher incidence of vomiting in the ETT group (Table 2). The ETT group also produced 3 adverse events. Two patients experienced bronchospasm after ETT removal, and 1 patient experienced an asthma attack in the PACU. The groups differed significantly (P  0.05) in time, with the LMA having shorter OR arrival to airway placement, end of procedure to PACU arrival, and OR arrival to discharge home, and highest sevoflurane concentration (Table 3). The groups did not differ in EGD duration, time from PACU arrival to discharge, lowest oxygen saturation, highest pain score, and endoscopist satisfaction.

DISCUSSION Although the standard practice at most adult institutions involves conscious sedation for EGDs, this is not ideal in the pediatric population (1). Most pediatric institutions do not start an intravenous drip until after the child is asleep and adequately anesthetized (6). Higher airway reactivity, less pulmonary reserve, and the need for more careful positioning make sedation difficult. Our institution previously routinely intubated every child scheduled for an EGD. The intubated patient provided comfort for the anesthesiologist, and familiarity and stability for the endoscopist. Intubation may not be the best option for a short procedure in an otherwise healthy child. The present study demonstrated that the use of an LMA for securing an airway in children undergoing elective EGD may be a suitable and safe alternative to endotracheal intubation. The use of LMA for EGDs in pediatric populations has been investigated previously. Osborn et al and Fuentes-Garcia et al (7,8) reported decreased extubation time in LMA group compared with ETT group (7.2 vs 12 minutes, 3 vs 4 minutes). In our study, the time from end of procedure to PACU was decreased in the LMA group compared with the ETT group (4.4 vs 9.2 minutes). In addition to the decreased PACU stay for the LMA group (60 vs 70.1 minutes), this may allow for additional patients scheduled. Dear et al (9) examined the use of LMAs for upper EGDs in 1027 patients at Duke University Health System. Their retrospective data analysis found LMAs could be used as safe substitutes to ETT but recommended using a smaller-size LMA and/or deflating TABLE 2. Complications reported after procedure completion

Vomiting Nausea Pain mediciney Adverse event

All (n ¼ 84)

ETT (n ¼ 42)

LMA (n ¼ 42)

 P

4 6 30 3

4 4 19 3

0 2 11 0

0.0404 0.40 0.07 0.08

ETT ¼ endotracheal tube; LMA ¼ laryngeal mask airway.  P value 0.05 defined as clinically significant. y Pain medicine given was oral Tylenol 10 mg/kg.

55

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Acquaviva et al

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TABLE 3. Comparisons for endotracheal tube versus laryngeal mask airway

OR arrival to airway placement, min End of procedure to PACU arrival, min OR to discharge, min PACU arrival to discharge, min Lowest oxygen saturation in PACU Highest sevoflurane concentration Highest pain score Endoscopist satisfaction

ETT (n ¼ 42)

LMA (n ¼ 42)

P

5.2  1.5 9.2  3.7 102.5  40.4 70.1  39.1 95.7  9.5 3.0  0.3 2.5  0.4 4.0  0

4.4  1.1 4.4  2.3 86.6  18.5 60.0  16.7 96.7  2.4 3.1  0.3 1.5  0.2 3.9  0.3

0.0035 2500 EGDs were performed with LMAs and there were no reported airway complications. Because of the demonstrated margin of safety and comfort of both the endoscopist and the anesthesiologist, LMAs for EGDs have become standard of practice at our institution. In conclusion, LMA appears to be an acceptable and safe alternative to tracheal intubation for otherwise healthy children ages 3 to 17, undergoing routine EGD. Benefits of using the LMA appear to be decreased incidence of vomiting and overall decreased time spent in the hospital. Further studies need to investigate whether there is a difference when the ETT is removed in a deep anesthetic state.

REFERENCES 1. Lightdale JR, Mahoney LB, Schwarz SM, et al. Methods of sedation in pediatric endoscopy: a survey of NASPGHAN members. J Pediatr Gastroenterol Nutr 2007;45:500–2. 2. Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta-analysis. Can J Anaesth 1995;42:1017–23. 3. Yu SH, Beirne OR. Laryngeal mask airways have a lower risk of airway complications compared with endotracheal intubation: a systematic review. J Oral Maxillofac Surg 2010;68:2359–76. 4. Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg 1996;82:129–33. 5. Sierpina DI, Chaudhary H, Walner DL, et al. Laryngeal mask airway versus endotracheal tube in pediatric adenotonsillectomy. Laryngoscope 2012;122:429–35. 6. Park JS, Kim KJ, Choi EK, et al. A randomized controlled trial comparing laryngeal mask airway removal during adequate anesthesia and after awakening in children 2 to 6 years. J Clin Anesth 2012; 24:537–41. 7. Osborn IP, Cohen J, Soper RJ, et al. Laryngeal mask airway—a novel method of airway protection during ERCP: comparison with endotracheal intubation. Gastrointest Endosc 2002;56:122–8. 8. Fuentes-Garcia VE, Morales-Perez E, Ramirez-Mora JC, et al. A randomized controlled trial comparing laryngeal mask airway to endotracheal tube in children undergoing upper endoscopy. Acta Biomed Ateneo Parmense 2006;77:90–4. 9. Dear GD, Ames WA, Eck JB, et al. Use of laryngeal mask airways for pediatric esophagogastroduodenoscopy: a report of 1027 cases. Paper presented at American Society of Anesthesiologists, Park Ridge, October 16, 2007. 10. Hohlrieder M, Brimacombe J, Goedecke A, et al. Postoperative nausea, vomiting, airway morbidity, and analgesic requirements are lower for the ProSeal laryngeal mask airway than the tracheal tube in females undergoing breast and gynaecological surgery. Br J Anaesth 2007; 99:576–80. 11. Joshi GP, Inagaki Y, White PF, et al. Use of the laryngeal mask airway as an alternative to the tracheal tube during ambulatory anesthesia. Anesth Analg 1997;85:573–7.

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Endotracheal intubation versus laryngeal mask airway for esophagogastroduodenoscopy in children.

The present study examined the safety and efficacy of a laryngeal mask airway (LMA), compared with an endotracheal tube (ETT), for children undergoing...
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