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

Ann & Robert H Lurie Children's Hospital of Chicago logo

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Completed

Conditions

Laryngeal Mask Airway in Children

Treatments

Device: LMA Supreme: comparison device
Device: LMA Unique: control device

Study type

Interventional

Funder types

Other

Identifiers

NCT01653795
LMA-U vs SLMA (multiple sizes)

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

3 months to 11 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

180 participants in 2 patient groups

LMA Unique
Active Comparator group
Treatment:
Device: LMA Unique: control device
LMA Supreme
Active Comparator group
Treatment:
Device: LMA Supreme: comparison device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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