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NCT01328405 · ClinicalTrials.gov registry record · Phase 4
Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT01328405: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT01328405 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328405, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.
Interventions
- DEVICE Laryngeal Mask Airway (LMA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
What the finished NCT01328405 record still lists
NCT01328405 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Laryngeal Mask Airway (LMA) is the first listed.
NCT01328405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328405 about?
NCT01328405 is a clinical study titled "Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal". 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 mar...
What is the current status of trial NCT01328405?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2009-10. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01328405?
The interventions under investigation include: Laryngeal Mask Airway (LMA) (DEVICE).
Who is sponsoring clinical trial NCT01328405?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01328405's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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