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LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

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

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Completed

Conditions

Children

Treatments

Device: air-QTM Intubating Laryngeal Airway
Device: Laryngeal Mask Airway

Study type

Observational

Funder types

Other

Identifiers

NCT01385761
IRB#2011-14642

Details and patient eligibility

About

The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.

Full description

The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Enrollment

60 patients

Sex

All

Ages

3 to 9 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children undergoing general anesthesia using a supraglottic airway device
  • 3 to 9 years of age
  • 20 to 30 kilograms in weight

Exclusion criteria

  • History of a difficult airway
  • Active gastrointestinal reflux
  • Active upper respiratory tract infection

Trial design

60 participants in 2 patient groups

Laryngeal Mask airway (LMA)
Description:
children weighing 20 to 30 kg
Treatment:
Device: Laryngeal Mask Airway
Intubating Laryngeal Airway (ILA-SP)
Description:
Children weighing 20-30 kg
Treatment:
Device: air-QTM Intubating Laryngeal Airway

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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