The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients

Completed

• Conditions: Children
• Interventions: Device: each child will receive both the LMA and ILA

• Registration Number: NCT01314248
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.

Detailed Description

The goal for this randomized, crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA 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. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these regards:

1. We hypothesize that airway leak pressures will be higher with the ILA. Airway leak pressures will be measured by recording the circuit pressure at which an equilibrium is reached.

2. We hypothesize that flexible fiberoptic view of the airway will be superior with the ILA. The airway view will be assessed using a previously used and published grading scale.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy children undergoing general anesthesia using a supraglottic airway device
• 6 months to 36 months of age
• 10 to 15 kilograms in weight

Exclusion Criteria

• Active respiratory infection
• History of difficult mask ventilation
• Features or history of a difficult airway
• Gastrointestinal reflux disease
• Clinically significant pulmonary disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children weighing 10 to 15 kg	each child will receive both the LMA and ILA	-

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States