Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy

• ClinicalTrials.gov Identifier: NCT01936662
• Recruitment Status: Completed
• First Posted: September 6, 2013
• Results First Posted: May 2, 2016
• Last Update Posted: May 2, 2016
• Sponsor: Indiana University
• Information provided by (Responsible Party): Indiana University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Airway Morbidity	Device: LMA; Device: ETT	Not Applicable

Detailed Description:

1. Study design The study will be randomized, controlled, and prospective in design.

2. Comparison groups The two comparison groups will be:

   1. Laryngeal Mask Airway Group (LMA), N = 42 LMA will be used as the intraoperative airway device.
   2. Endotracheal Tube Group (ETT), N = 42 ETT will be used as the intraoperative airway device.

3. Study and timeline of interventions

   1. Preoperative: All patients enrolled in this study will receive a standard preoperative dose of oral midazolam 0.5 mg/kg up to 15 mg, 15 to 30 minutes prior to anesthetic induction.
   2. Intraoperative: Subjects will all undergo induction of anesthesia by inhalation of sevoflurane and oxygen. An intravenous catheter (IV) will be placed, followed by lidocaine 2mg/kg IV. The airway device will be placed (LMA or ETT). As required for the procedure, the subject will be placed in a left lateral decubitus (left side down) position. Maintenance of anesthesia will be provided with sevoflurane at a concentration of 1.5-2 MAC, or higher if deemed appropriate for the clinical setting as judged by the anesthesiologist. All participants will be given the anti-nausea medicine ondansetron 0.1mg/kg (maximum 4 mg) after placement of the airway device. When the endoscope is removed at the completion of the procedure, the patient will be returned to the supine position. The sevoflurane will be discontinued and the airway device will be removed when the anesthesiologist deems it appropriate. Prior to leaving the OR, the anesthesiologist may give pain or anti-anxiety medicine as needed.
   3. Postoperative: All patients will receive routine PACU care. Pain and anxiety scores will be recorded according to routine PACU practice. Medication for pain, nausea, and anxiety will be given according to the judgment of the anesthesiologist.
   4. Measured end-points:

   i. Time from induction of anesthesia to placement of the airway device ii. Time from end of procedure to arrival in the PACU iii. Time spent in the PACU iv. Overall time from arrival in the OR to discharge home v. Vomiting after the procedure vi. Nausea requiring medicine after the procedure vii. Lowest oxygen saturation level during or after the procedure viii. Highest concentration of sevoflurane during the procedure ix. Highest pain level after the procedure x. Amount of pain medicine given xi. Adverse events xii. Satisfaction level of the doctor doing the EGD

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Official Title: Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children
• Study Start Date: August 2011
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Largyngeal Mask Airway for EGD procedure; Patients randomized to LMA to maintain airway through EGD procedure	Device: LMA; Patients randomized to the LMA group had their airways maintained with a LMA device
Active Comparator: Endotracheal Tube for EGD procedure; Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital	Device: ETT; Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital

Outcome Measures

Primary Outcome Measures :

1. Endoscopist Satisfaction [ Time Frame: 2 hours ]

   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.

Secondary Outcome Measures :

1. OR to Discharge (Min) [ Time Frame: OR to discharge ]
   Overall time from arrival in the OR to discharge home (in minutes)

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Indiana

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Micahel Acquaviva, MD; Indiana University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT01936662
• Other Study ID Numbers: 1011002885
• First Posted: September 6, 2013
• Results First Posted: May 2, 2016
• Last Update Posted: May 2, 2016
• Last Verified: April 2016

Keywords provided by Indiana University:

Airway management comparison