University of Wisconsin Hopital and Clinics
Madison, Wisconsin, 53792, United States
NCT Number: NCT03247803
The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be used for primary airway maintenance or as a conduit for FOI, as can be the Williams, Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that dynamically adjusts according to the relative resistances to airflow between the patient's lungs and the device's cuff. The purpose of this study is to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation (FBI) and to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation. Both devices are commercially-available and being used in the study in accordance with their labeled intended use. The investigator envisage that the endpoint of the study will be single operator intubation success rate.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
Despite the introduction of videolaryngoscopes, flexible bronchoscopic intubation (FBI), also known as fiberoptic intubation (FOI), remains a critical method for achieving tracheal intubation in patients with difficult airways. Unfortunately, however, FOI often requires two-operators for success. One operator is required to manipulate the flexible bronchoscope through the patient's upper airway and into their trachea, while the second operator applies one or more maneuvers (e.g., jaw thrust, anterior jaw lift, or lingual retraction) with or without the use of a commercially-available fiberoptic intubating airway.
Previous studies have demonstrated the effectiveness of the currently available FIAs, but also illustrate the frequent need for an assistant for successful FOI. In this study, an assistant performed a jaw lift and a chin lift in all subjects as well.
The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be used for primary airway maintenance or as a conduit for FOI, as can be the Williams, Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that dynamically adjusts according to the relative resistances to airflow between the patient's lungs and the device's cuff. In prior trials comparing the air-Q and air-Q SP with the two other commercially-available SGAs, the air-Q and air-Q SP bowl design provided a partial or full view of the vocal cords in 80-92% of subjects without requiring any additional airway maneuvers applied by an assistant (e.g., jaw thrust, anterior jaw lift, or lingual retraction) (Galgon, 2011; Galgon, 2015). Presumably, in these situations, successful tracheal intubation using the air-Q or air-Q SP could have been achieved by a single operator versus requiring one or more assistants. However, this potential performance advantage has not yet been tested. Therefore, the purpose of this study is to compare use of the air-Q SP against the WA for FBI performed by a single operator.
The air-Q SP, rather than the air-Q, is chosen for this study because its lack of a pilot balloon valve allows its stem to be easily shortened to ease device removal over the coaxially placed tracheal tube. The WA is chosen for this study because it has performed best in past trials and is the airway routinely used by the study principal investigator (PI) for FBI. Both devices are commercially-available and being used in the study in accordance with their labeled intended use.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
air-Q SP placement for airway maintenance,
Other names: air-Q SP placement for airway maintenance
WA is placed in subject's oropharynx. If the vocal cords are not in view at the end of the WA, the operator may ask an assistant to perform an airway maneuver (e.g., jaw thrust, anterior jaw lift, or lingual traction) to attempt to bring the vocal cords into view
Other names: WA is placed in subject's oropharynx.
Time frame: 15 minutes
The primary purpose of this study is to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation.
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 15 minutes
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
Time frame: 4 hours
The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
University of Wisconsin, Madison
Other
Comparison of Use of a Shortened Air-Q® Self-Pressurizing Intubating Laryngeal Airway Versus the Williams Intubating Airway for Single-Operator Flexible Bronchoscopic Intubation.
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