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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT05083403
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who are at least 18 years of age
2. Subjects who have signed the Informed Consent Form
3. Subjects with planned pressure monitoring with an arterial line
4. Subjects with planned sternotomy
5. Subjects with planned general anesthesia
6. Subjects who have ASA Physical Status ≤ 4
7. Subjects with planned cerebral oximetry monitoring
8. Subjects with planned overnight hospitalization
9. Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery
Exclusion Criteria:
1. Subjects with a physical site area too limited for proper Sensor placement
2. Subjects with contraindications for Arterial Line Placement;
3. Subjects participating in another (interventional) study
4. Subjects in whom an intraoperative MAP target will be \< 65 mmHg
5. Subjects with pre-op or pre-pump or post-pump LVEF \< 15%
6. Subjects requiring heart transplant
7. Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass
8. Subjects requiring emergency surgery
9. Subjects with known or identified severe PAH (defined as pulmonary systolic pressure\> 70mmHg or mean pressures \> 55mmHg) as determined by a pre-operative echo or intraoperative Swan-Ganz
10. Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05083403
Study Brief:
Protocol Section:
NCT05083403