Back to resultsLaryngeal Mask Airway in Pediatric Adenotonsillectomy (LMA)
Primary Purpose
Sleep Apnea, Obstructive, Tonsillitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ETT with non modified retractor
LMA with modified retractor
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring adenotonsillectomy
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of the King's Daughters
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LMA with modified retractor
ETT with non modified retractor
Arm Description
LMA with modified retractor
ETT with non modified retractor
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01695980
First Posted
September 24, 2012
Last Updated
April 1, 2022
Sponsor
Eastern Virginia Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01695980
Brief Title
Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Acronym
LMA
Official Title
Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Virginia Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Tonsillitis
Keywords
adenotonsillectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LMA with modified retractor
Arm Type
Experimental
Arm Description
LMA with modified retractor
Arm Title
ETT with non modified retractor
Arm Type
Active Comparator
Arm Description
ETT with non modified retractor
Intervention Type
Procedure
Intervention Name(s)
ETT with non modified retractor
Intervention Description
adenotonsillectomy
Intervention Type
Other
Intervention Name(s)
LMA with modified retractor
Intervention Description
LMA with modified retractor
Primary Outcome Measure Information:
Title
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To determine total length of procedure and recovery time with use the LMA.
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Baldassari, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Laryngeal Mask Airway in Pediatric Adenotonsillectomy
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