Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
1 other identifier
interventional
131
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedResults Posted
Study results publicly available
January 13, 2011
CompletedNovember 13, 2017
October 1, 2017
1.7 years
June 7, 2010
November 10, 2010
October 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Laryngospasm
2 years
Secondary Outcomes (1)
Postanesthesia Recovery Times
After surgery
Study Arms (2)
Endotracheal Tube
EXPERIMENTALChildren undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Laryngeal Mask Airway
EXPERIMENTALChildren undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Interventions
Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
Randomized to either Laryngeal mask airway or endotracheal tube
Eligibility Criteria
You may qualify if:
- Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virigina Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Related Publications (1)
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. doi: 10.1093/bja/70.1.30.
PMID: 8240471BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cristina Baldassari
- Organization
- Eastern Virginia Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Kelley Dodson, MD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 10, 2010
Study Start
December 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
November 13, 2017
Results First Posted
January 13, 2011
Record last verified: 2017-10