A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children

November 17, 2012 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications will also be assessed.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children undergoing general anesthesia using a supraglottic airway device

Exclusion Criteria:

  • ASA class IV, V, Emergency procedures
  • active respiratory infection
  • known history of difficult mask ventilation
  • a diagnosis of a congenital syndrome associated with difficult airway management
  • airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
  • active gastrointestinal reflux
  • coagulopathy
  • clinically significant pulmonary disease(s)

Study Plan

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

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LMA Supreme
Device: LMA Supreme: comparison device
LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other Names:
  • Laryngeal Mask Airway
Active Comparator: LMA Unique
Device: LMA Unique: control device
LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other Names:
  • Laryngeal Mask Airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway Leak Pressure
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed.
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to secure the airway
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
From picking up the airway device to bilateral chest expansion and presence of ETCO2
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of attempts to place the device
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Fiberoptic grade of laryngeal view
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The laryngeal alignment through the devices will be graded using an established scoring system
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Gastric insufflation
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Quality of the airway
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Incidence of device repositioning and/or replacement
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%.
Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Ease of gastric tube placement (only in patients who receive LMA Supreme)
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The ease of gastric placement will be timed and assessed using a subjective scale. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device.
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Oropharyngolaryngeal morbidity at discharge
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Oropharyngolaryngeal morbidity at 24 hours post-operatively
Time Frame: Measured at 24 hours after device placement/study initiation
Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Measured at 24 hours after device placement/study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 17, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • LMA-U vs SLMA (multiple sizes)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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