Air-Q® SP Versus Williams Intubating Airway for Single-Operator FOI

Completed · Not applicable

Conditions studied: Intubation; Difficult or Failed, Laryngeal Masks

In brief

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.

Key facts

Study ID

NCT03247803

Run by

University of Wisconsin, Madison

People needed

60

Starts

2018-06-11

Expected to finish

2019-03-08

Last updated by the study team

2019-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥18 years);
• The patient is scheduled for an elective surgery or procedure that will take place in the UWHC main operating room, outpatient surgical center, or ambulatory procedure center; and
• The patient's primary anesthesia care team has planned for general anesthesia with orotracheal intubation for airway maintenance.

You may not qualify if…

• The patient is < 18 years of age;
• The patient is non-English speaking;
• The patient is known or believed to be pregnant;
• The patient is a prisoner;
• The patient has impaired decision-making capacity;
• The patient is at increased risk for aspiration, including non-fasted or emergency surgery, and cases of uncontrolled gastroesophageal reflux disease, hiatal hernia, gastroparesis, esophageal dysmotility, prior esophagectomy, and/or emesis within twenty-four hours of the surgery or procedure;
• The patient has limited mouth opening or oropharyngeal anatomy making successful placement of the study airway conduit unlikely;
• The patient has airway exam features, a medical condition, or a past airway management history, which prompts the attending anesthesiologist to plan to maintain spontaneous ventilation during tracheal intubation;
• The patient pre-operatively is requiring supplemental oxygen;
• The patient has moderate to severe cardiac disease, as evidenced by a left ventricular ejection fraction of ≤ 50% on the most recent echocardiogram, severe aortic valve stenosis, atrial fibrillation with a resting pre-operative heart rate of ≥ 90 beats per minute, and/or known, multi-vessel coronary artery, managed conservatively with medical management or by intervention with multiple coronary artery stents or coronary bypass grafting; and
• The patient has an allergy to glycopyrrolate.

Where it is running

• University of Wisconsin Hopital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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