Phase 4
N=100
Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal
Difficult Airway · Anesthesia; Functional
Bottom Line
View on ClinicalTrials.gov: NCT01328405 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Airway Seal Pressure — 30; 30 cmH2O
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Laryngeal Mask Airway (LMA) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Seal Pressure |
30; 30 | — |
| SECONDARY Grossly Visible Blood or Bile on LMA |
10; 4 | — |
| SECONDARY Glottic View |
41; 29 | — |
| SECONDARY Airway Pathology |
21; 10 | — |
| SECONDARY Airway Pathology |
21; 10 | — |
Summary
Introduction:
The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved for use as a primary airway and as an aid for intubation in situations of anticipated or unanticipated difficult airways. A unique feature of this device as compared to other airways on the market is the size of the inner diameter (ID) and length of its airway tube. Direct placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.
The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.
In this study the investigators aim to test whether the air-QⓇ creates an airway seal pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the LMA-ProSealTM.
Eligibility Criteria
Inclusion Criteria
- Patients who are 18 years or greater may be included if they presenting for any elective surgery or procedure to take place in any anesthetic location and require placement of a LMA for their surgery or procedure.
Exclusion Criteria
- non-English speaking
- pregnant
- are a minor
- are a prisoner
- have impaired decision-making capacity or any condition for which the primary anesthesia team deems intubation with a tracheal tube to be necessary
Data sourced from ClinicalTrials.gov (NCT01328405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.