Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Tonsillitis
• Interventions: Other: LMA with modified retractor; Procedure: ETT with non modified retractor

• Registration Number: NCT01695980
• Lead Sponsor: Eastern Virginia Medical School

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Primary Completion: 2022-03-29
• Study Completion: 2022-03-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA with modified retractor	LMA with modified retractor	LMA with modified retractor
ETT with non modified retractor	ETT with non modified retractor	ETT with non modified retractor

Primary Outcome Measures

Name	Time	Method
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.	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.

Secondary Outcome Measures

Name	Time	Method
To determine total length of procedure and recovery time with use the LMA.	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.

Trial Locations

Locations (1)

Children's Hospital of the King's Daughters; 🇺🇸 Norfolk, Virginia, United States