Completed

LMALaryngeal Mask Airway in Pediatric Adenotonsillectomy

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What is being tested

LMA with modified retractor

+ ETT with non modified retractor

OtherProcedure
Who is being recruted

Apnea+13

+ Infections

+ Stomatognathic Diseases

From 2 to 16 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorEastern Virginia Medical School
Last updated: April 11, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01695980
Principal SponsorEastern Virginia Medical School
Last updated: April 11, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

81 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaInfectionsStomatognathic DiseasesNervous System DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesPharyngitisRespiration DisordersRespiratory Tract DiseasesRespiratory Tract InfectionsSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasTonsillitisSleep Apnea, Obstructive

Criteria

1 inclusion criteria required to participate
requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16
4 exclusion criteria prevent from participating
children under 2 or over 16
children with BMI > 35
children with craniofacial anomalies/abnormalities which will interfere with mask placement
unwillingness to comply with study procedures

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
LMA with modified retractor

Group II

Active Comparator
ETT with non modified retractor

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Children's Hospital of the King's Daughters

Norfolk, United StatesOpen Children's Hospital of the King's Daughters in Google Maps
CompletedOne Study Center