Laryngeal Mask Airway in Pediatric Adenotonsillectomy (LMA)

April 1, 2022 updated by: Cristina Baldassari M.D., Eastern Virginia Medical School
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of the King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LMA with modified retractor
Other: LMA with modified retractor
LMA with modified retractor
Active Comparator: ETT with non modified retractor
Procedure: ETT with non modified retractor
adenotonsillectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.
Time Frame: one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine total length of procedure and recovery time with use the LMA.
Time Frame: One year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Investigators

  • Principal Investigator: Christina Baldassari, MD, Eastern Virginia Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

March 29, 2022

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • version 4 25Jun2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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