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NCT01695980 Clinical Trial

Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Sleep Apnea, Obstructive Clinical Trial

— LMA  

Official title:
Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01695980
Other study ID # version 4 25Jun2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date March 29, 2022

Study information
Verified date April 2022
Source Eastern Virginia Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used.

Description:

The laryngeal mask airway (LMA)is a device used to secure the airway of patients during general anesthesia. This device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be studied as it pertains to operative times and cost. The child will be randomized into either the LMA group or the ETT group.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date March 29, 2022
Est. primary completion date March 29, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria: - requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16 Exclusion Criteria: - children with BMI >35 - unwillingness to comply with study procedures - children with craniofacial anomalies/abnormalities which will interfere with mask placement - children under 2 or over 16

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ETT with non modified retractor
adenotonsillectomy
Other:
• LMA with modified retractor
LMA with modified retractor

Locations
Country Name City State
United States Children's Hospital of the King's Daughters Norfolk Virginia

Sponsors (1)
Lead Sponsor Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy. Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy. one year
Secondary To determine total length of procedure and recovery time with use the LMA. Does the rate of kinking/obstruction of the tubing cause prolonged procedure time and additional issues for anesthesia and the subsequent recovery of the patient. One year
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