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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01385761

Enrollment

Registered

2011-06-30

Start date

2011-06-30

Completion date

2012-03-31

Last updated

2012-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children

Keywords

Supraglottic airway devices

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.

Interventions

DEVICELaryngeal Mask Airway

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

DEVICEair-QTM Intubating Laryngeal Airway

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 9 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Oropharyngeal leak pressure	2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026