Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Sleep Apnea, Obstructive Clinical Trial

— LMA  

Official title:

Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695980
• Other study ID #: version 4 25Jun2012
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: March 29, 2022

Study information

• Verified date: April 2022
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Procedure:
• ETT with non modified retractor
adenotonsillectomy

Other:
• LMA with modified retractor
LMA with modified retractor

Locations

Country	Name	City	State
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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