N/A
N=225
Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial
Laryngeal Masks
Bottom Line
View on ClinicalTrials.gov: NCT01592760 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Airway Seal Pressure After Device Placement — 28; 27; 24 cmH2O
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- air-Q SP (Device); air-Q (Device); i-gel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Seal Pressure After Device Placement |
28; 27; 24 | — |
| SECONDARY Device Placement Time |
25; 19; 21 | — |
| SECONDARY Device Placement Success Rate |
83; 84; 41; 6; 3; 4 | — |
| SECONDARY Device Ease of Insertion |
73; 77; 38; 16; 11; 7 | — |
| SECONDARY Device Position in Relation to the Vocal Cords |
62; 71; 28; 6; 4; 10 | — |
| SECONDARY Device Use Time (Min) |
60; 65; 70 | — |
| SECONDARY Incidence of Gastric Insufflation |
0; 0; 0 | — |
| SECONDARY Incidence of Gastric Aspiration |
0; 0; 0 | — |
| SECONDARY Incidence of Oropharyngeal Injury |
2; 0; 1 | — |
| SECONDARY Overall Clinical Usefulness |
56; 65; 24; 6; 4; 1 | — |
| SECONDARY Oropharyngolaryngeal Morbidity at Discharge |
38; 28; 7; 29; 20; 3 | — |
| SECONDARY Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively |
42; 50; 15; 37; 37; 7 | — |
Summary
The air-Q Self-Pressurizing Intubating Laryngeal Airway (aILA SP) is a modification of the air-Q Intubating Laryngeal Airway (aILA). Besides the i-gel, it is the only breathing tube that sits above the vocal cords that does not require inflation of a cuff with air. The purpose of this study is to compare the ability of the aILA-SP to maintain patency of a patient's airway during general anesthesia with that of the aILA and i-gel devices. As a measure of this ability, we hypothesized that the airway sealing pressures will be equal between the aILA-SP and aILA, but superior when comparing the aILA-SP to the i-gel (i-gel will be lower).
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years;
- scheduled for an elective surgery or procedure; and
- general anesthesia with placement of a SGA planned.
Exclusion Criteria
- < 18 years of age;
- non-English speaking;
- known or believed to be pregnant;
- prisoner;
- has impaired decision-making capacity;
- has symptomatic untreated gastroesophageal reflux;
- has had a prior esophagectomy;
- has a known or suspected hiatal hernia;
- has vomited within twenty-four hours of the surgery or procedure;
- has known oral pathology making a proper SGA fit unlikely; or
- has any condition for which the primary anesthesia care team deems intubation with a tracheal tube to be necessary.
Data sourced from ClinicalTrials.gov (NCT01592760). 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.