Clinical trial NCT01936662: Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy
Official title: Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: Airway management comparison
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Esophagogastroduodenoscopy (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 sedation, children most often require general anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of children for EGD can result in delayed awakening and slow room turnover, particularly when intravenous medications are required for intubation. Laryngeal mask airway (LMA) is an alternative to intubation, which permits removal before full awakening.

Although considered a safe alternative to tracheal intubation in appropriate cases, 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. The study was designed to determine whether use of an LMA for EGD could reduce operating room time, while providing satisfactory conditions for the endoscopist, and an equivalent side effect and safety profile as compared to ETT in otherwise healthy children with gastrointestinal complaints

Detailed description: 1. Study design The study will be randomized, controlled, and prospective in design.
2. Comparison groups The two comparison groups will be:

   1. Laryngeal Mask Airway Group (LMA), N = 42 LMA will be used as the intraoperative airway device.
   2. Endotracheal Tube Group (ETT), N = 42 ETT will be used as the intraoperative airway device.
3. Study and timeline of interventions

   1. Preoperative: All patients enrolled in this study will receive a standard preoperative dose of oral midazolam 0.5 mg/kg up to 15 mg, 15 to 30 minutes prior to anesthetic induction.
   2. Intraoperative: Subjects will all undergo induction of anesthesia by inhalation of sevoflurane and oxygen. An intravenous catheter (IV) will be placed, followed by lidocaine 2mg/kg IV. The airway device will be placed (LMA or ETT). As required for the procedure, the subject will be placed in a left lateral decubitus (left side down) position. Maintenance of anesthesia will be provided with sevoflurane at a concentration of 1.5-2 MAC, or higher if deemed appropriate for the clinical setting as judged by the anesthesiologist. All participants will be given the anti-nausea medicine ondansetron 0.1mg/kg (maximum 4 mg) after placement of the airway device. When the endoscope is removed at the completion of the procedure, the patient will be returned to the supine position. The sevoflurane will be discontinued and the airway device will be removed when the anesthesiologist deems it appropriate. Prior to leaving the OR, the anesthesiologist may give pain or anti-anxiety medicine as needed.
   3. Postoperative: All patients will receive routine PACU care. Pain and anxiety scores will be recorded according to routine PACU practice. Medication for pain, nausea, and anxiety will be given according to the judgment of the anesthesiologist.
   4. Measured end-points:

   i. Time from induction of anesthesia to placement of the airway device ii. Time from end of procedure to arrival in the PACU iii. Time spent in the PACU iv. Overall time from arrival in the OR to discharge home v. Vomiting after the procedure vi. Nausea requiring medicine after the procedure vii. Lowest oxygen saturation level during or after the procedure viii. Highest concentration of sevoflurane during the procedure ix. Highest pain level after the procedure x. Amount of pain medicine given xi. Adverse events xii. Satisfaction level of the doctor doing the EGD

Eligibility criteria: Inclusion Criteria:• Age 3-17

* Scheduled for Esophagogastroduodenoscopy, with or without biopsies
* Have been informed of the nature of the study and informed consent has been obtained from the legally responsible
* Have provided assent in accordance with Institutional Review Board requirements
* Are able to complete pain assessment evaluations as determined by preoperative evaluations

Exclusion Criteria:

* • Abnormal/difficult airway

  * Symptomatic obstructive sleep apnea
  * Risk of aspiration of stomach contents
  * Upper respiratory infection within last 14 days
  * Allergy to lidocaine or ondansetron
  * EGD procedures associated with the need to exclude ondansetron administration
  * BMI \>85th percentile for age
  * Are unable to communicate effectively with study personnel
  * Have a positive urine pregnancy test (menstruating females only at screening

Primary outcomes:
measure: Endoscopist Satisfaction
timeFrame: 2 hours
Secondary outcomes:
measure: OR to Discharge (Min)
timeFrame: OR to discharge
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Micahel Acquaviva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acquaviva MA, Horn ND, Gupta SK. Endotracheal intubation versus laryngeal mask airway for esophagogastroduodenoscopy in children. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):54-6. doi: 10.1097/MPG.0000000000000348.