Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Conditions
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Tonsillitis, Sleep Apnea, Obstructive

Intervention / Treatment
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* Procedure: ETT with non modified retractor
* Other: LMA with modified retractor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA with modified retractor<br>LMA with modified retractor | Other: LMA with modified retractor<br>* LMA with modified retractor<br>|
| Active Comparator: ETT with non modified retractor<br>ETT with non modified retractor | Procedure: ETT with non modified retractor<br>* adenotonsillectomy<br>|

What is the study measuring?
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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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenotonsillectomy