Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT03247803
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (≥18 years);
2. 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
3. The patient's primary anesthesia care team has planned for general anesthesia with orotracheal intubation for airway maintenance.
Exclusion Criteria:
1. The patient is \< 18 years of age;
2. The patient is non-English speaking;
3. The patient is known or believed to be pregnant;
4. The patient is a prisoner;
5. The patient has impaired decision-making capacity;
6. 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;
7. The patient has limited mouth opening or oropharyngeal anatomy making successful placement of the study airway conduit unlikely;
8. 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;
9. The patient pre-operatively is requiring supplemental oxygen;
10. 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
11. The patient has an allergy to glycopyrrolate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03247803
Study Brief:
Protocol Section:
NCT03247803