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Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy

NCT01936662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-05-02

Study results available
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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

Conditions

  • Airway Morbidity

Interventions

DEVICE

LMA

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

DEVICE

ETT

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Micahel Acquaviva, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-07-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936662 on ClinicalTrials.gov