CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Laryngeal Mask Airway (LMA)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01328405
NCT01328405Phase 4Completed

The Air-Q Intubating Laryngeal Airway Versus the LMA-Proseal: A Prospective, Randomized Trial of Airway Seal Pressure

University of Wisconsin, Madison·interventional·Posted Apr 4, 2011·Updated Oct 23, 2015

In Brief

A Phase 4 clinical trial evaluating Laryngeal Mask Airway (LMA) for Difficult Airway and Anesthesia; Functional. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2011
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.2 years ago

Interventions

Laryngeal Mask Airway (LMA)device

Comparison of airway seal pressure, airway morbidity bronchoscopic view obtained between two different laryngeal mask airways.