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A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel 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 Masks in Children

Treatments

Device: LMA Supreme: control device
Device: i-gel: comparison device

Study type

Interventional

Funder types

Other

Identifiers

NCT01633073
SLMA vs i-gel

Details and patient eligibility

About

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.

Full description

The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.

Enrollment

170 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
  • weight 5-50 kg
  • age 3 months-11 years

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

170 participants in 2 patient groups

LMA Supreme
Active Comparator group
Treatment:
Device: LMA Supreme: control device
i-gel
Active Comparator group
Treatment:
Device: i-gel: comparison device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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