Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2022-03-29

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.

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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.

Conditions

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Sleep Apnea, Obstructive Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LMA with modified retractor

Group Type EXPERIMENTAL

LMA with modified retractor

Intervention Type OTHER

LMA with modified retractor

ETT with non modified retractor

Group Type ACTIVE_COMPARATOR

ETT with non modified retractor

Intervention Type PROCEDURE

adenotonsillectomy

Interventions

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ETT with non modified retractor

adenotonsillectomy

Intervention Type PROCEDURE

LMA with modified retractor

Intervention Type OTHER

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No