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Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01141660
First received: June 7, 2010
Last updated: February 21, 2012
Last verified: March 2011
History of Changes
  Purpose

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
Tonsillectomy
 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Number of Participants With Laryngospasm [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anesthetic and Recovery Times [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141660

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

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013