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Completed

NCT Number: NCT01695980

Laryngeal Mask Airway in Pediatric Adenotonsillectomy

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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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Infections Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Tonsillitis

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETT with non modified retractor

Procedure

adenotonsillectomy

LMA with modified retractor

Other

LMA with modified retractor

Primary outcomes

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

    Time frame: 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 outcomes

  1. To determine total length of procedure and recovery time with use the LMA.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Acronym: LMA

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2012
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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