Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202, United States
NCT Number: NCT01936662
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
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Notify Me3 year–17 year
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
• Age 3-17
Exclusion criteria
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
Time frame: 2 hours
Endoscopist was surveyed to determine their satisfaction with each of the airway devices.
Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:
Time frame: OR to discharge
Overall time from arrival in the OR to discharge home (in minutes)
Indiana University
Other
Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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