Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Tonsillectomy Clinical Trial

Official title:

Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141660
• Other study ID #: HM10692
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: October 12, 2017
• Start date: December 2007
• Est. completion date: August 2009

Study information

• Verified date: October 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Mask Airway
• Tonsillectomy

Intervention

Device:
• Endotracheal Tube
Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
• Laryngeal mask airway
Randomized to either Laryngeal mask airway or endotracheal tube

Locations

Country	Name	City	State
United States	Virigina Commonwealth University Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Laryngospasm		2 years
Secondary	Postanesthesia Recovery Times		After surgery