N/A
N=84
Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy
Airway Morbidity
Bottom Line
View on ClinicalTrials.gov: NCT01936662 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Endoscopist Satisfaction — 1.0; 1.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LMA (Device); ETT (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoscopist Satisfaction |
1.0; 1.1 | — |
| SECONDARY OR to Discharge (Min) |
86.6; 102.5 | — |
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
Eligibility Criteria
Inclusion Criteria:• Age 3-17
- Scheduled for Esophagogastroduodenoscopy, with or without biopsies
- Have been informed of the nature of the study and informed consent has been obtained from the legally responsible
- Have provided assent in accordance with Institutional Review Board requirements
- Are able to complete pain assessment evaluations as determined by preoperative evaluations
Exclusion Criteria
- • 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
Data sourced from ClinicalTrials.gov (NCT01936662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.