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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

June 7, 2010
February 21, 2012
December 2007
August 2009   (final data collection date for primary outcome measure)
Number of Participants With Laryngospasm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Rates of Laryngospasm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01141660 on ClinicalTrials.gov Archive Site
Anesthetic and Recovery Times [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Laryngeal Mask Airway
  • Tonsillectomy
  • Device: Endotracheal Tube
    Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
    Other Names:
    • ETT
    • Endotracheal intubation
  • Device: Laryngeal mask airway
    Randomized to either Laryngeal mask airway or endotracheal tube
    Other Name: LMA
  • Experimental: Endotracheal Tube
    Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
    Intervention: Device: Endotracheal Tube
  • Experimental: Laryngeal Mask Airway
    Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
    Intervention: Device: Laryngeal mask airway
Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141660
VCU IRB# HM10692
No
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Kelley Dodson, MD Virginia Commonwealth University
Virginia Commonwealth University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP