Airway Morbidity Clinical Trial
Official title:
Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children
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
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
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