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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01881269
Eligibility Criteria:
Inclusion Criteria:
* Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
* American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
* Body mass index (BMI) ≤30 kg/m2.
* Subject is willing and able to provide written consent.
Exclusion Criteria:
* Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
* Female subjects who are currently lactating and breastfeeding.
* Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
* Subject has an abnormality that may prevent proper application of the device/sensors.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
* Subject has an implanted pacemaker.
* Subjects with non-sinus rhythm, frequent premature ventricular complexes (\> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
* Subjects with artificial finger nails.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01881269
Study Brief:
Protocol Section:
NCT01881269