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Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

This study has been completed.
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: June 7, 2010
Last updated: February 21, 2012
Last verified: March 2011
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.

Condition Intervention
Laryngeal Mask Airway
Device: Endotracheal Tube
Device: Laryngeal mask airway

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Number of Participants With Laryngospasm [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Anesthetic and Recovery Times [ Time Frame: 2 years ]

Enrollment: 131
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endotracheal Tube
Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Device: Endotracheal Tube
Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
Other Names:
  • ETT
  • Endotracheal intubation
Experimental: Laryngeal Mask Airway
Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Device: Laryngeal mask airway
Randomized to either Laryngeal mask airway or endotracheal tube
Other Name: LMA


Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.

Exclusion Criteria:

  • Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.
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Please refer to this study by its identifier: NCT01141660

United States, Virginia
Virigina Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Kelley Dodson, MD Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University Identifier: NCT01141660     History of Changes
Other Study ID Numbers: VCU IRB# HM10692
Study First Received: June 7, 2010
Results First Received: November 10, 2010
Last Updated: February 21, 2012 processed this record on May 25, 2017