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

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.

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Key information

Conditions

Children

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Memorial Hospital

Chicago, Illinois, 60618, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal mask airway

Device

Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Other names: Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA)

air-QTM Intubating Laryngeal Airway

Device

Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Other names: air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA

Primary outcomes

Oropharyngeal leak pressure

Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 30, 2011
Registry last updated: Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed