Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy

NCT01936662 | Completed Results DMC

• 1 other identifier: 1011002885
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Airway management comparison

Outcome Measures

Primary Outcomes (1)

• Endoscopist Satisfaction

  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: 1. The airway device did not interfere at all with the ability to perform the scope. 2. The airway device presented some interference with the scope, but not enough to cause difficulty. 3. The airway device made it difficult to perform the endoscopy. 4. The airway device prevented the endoscopy from being performed.

  2 hours

Secondary Outcomes (1)

• OR to Discharge (Min)

  OR to discharge

Study Arms (2)

Largyngeal Mask Airway for EGD procedure

EXPERIMENTAL

Patients randomized to LMA to maintain airway through EGD procedure

Device: LMA

Endotracheal Tube for EGD procedure

ACTIVE COMPARATOR

Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital

Device: ETT

Interventions

LMA DEVICE

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

Largyngeal Mask Airway for EGD procedure

ETT DEVICE

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

Endotracheal Tube for EGD procedure

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Acquaviva MA, Horn ND, Gupta SK. Endotracheal intubation versus laryngeal mask airway for esophagogastroduodenoscopy in children. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):54-6. doi: 10.1097/MPG.0000000000000348.

  PMID: 24637966 DERIVED

Results Point of Contact

• Title: Nicole Horn, MD
• Organization: IndianaU

ndhorn@hotmail.com

3179449981

Study Officials

• Micahel Acquaviva, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 6, 2013
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 2, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-04

Locations

US (1)