Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy
Condition: Airway Morbidity
Study type: Interventional

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
    

Intervention name(s): LMA; ETT
Intervention type(s): Device; Device
Intervention description(s): Patients randomized to the LMA group had their airways maintained with a LMA device; Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Airway management comparison