Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy
Completed · Not applicable
Conditions studied: Airway Morbidity
In brief
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
Key facts
- Study ID
- NCT01936662
- Run by
- Indiana University
- People needed
- 84
- Starts
- 2011-08-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2016-05-02
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- • 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
Where it is running
- Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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