Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy

Airway Morbidity Clinical Trial

Official title:

Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936662
• Other study ID #: 1011002885
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: April 25, 2016
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• LMA
Patients randomized to the LMA group had their airways maintained with a LMA device
• ETT
Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital

Locations

Country	Name	City	State
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: The airway device did not interfere at all with the ability to perform the scope.; The airway device presented some interference with the scope, but not enough to cause difficulty.; The airway device made it difficult to perform the endoscopy.; The airway device prevented the endoscopy from being performed.	2 hours	No
Secondary	OR to Discharge (Min)	Overall time from arrival in the OR to discharge home (in minutes)	OR to discharge	No