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

Completed

• Conditions: Children
• Interventions: Device: Laryngeal Mask Airway; Device: air-QTM Intubating Laryngeal Airway

• Registration Number: NCT01385761
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-09
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	2 months

Trial Locations

Locations (1)

Childrens Memorial Hospital; 🇺🇸 Chicago, Illinois, United States