CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
LMA +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01936662
NCT01936662N/ACompleted

Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children

Indiana University·interventional·Posted Sep 6, 2013·Updated May 2, 2016

In Brief

A clinical study evaluating LMA and ETT for Airway Morbidity. Completed, enrolled 84 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 6, 2013
Enrollment StartAug 1, 2011
Primary CompletionJul 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.8 years ago

Interventions

LMAdevice

Patients randomized to the LMA group had their airways maintained with a LMA device

ETTdevice

Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital