Cardiopulmonary Bypass Surgery
Conditions
Keywords
cardiopulmonary bypass
Brief summary
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.
Interventions
The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
Non-protocolized standard of care to treat subjects
Sponsors
Edwards Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Duration of Hypotension (Defined as MAP < 65mmHg) in Minutes. | From post-bypass procedure period to the first 8-hour ICU period (one day) |
Countries
United States
Participant flow
Pre-assignment details
At the time of study termination, 170 participants were enrolled. A total of 152 participants were analyzed for study outcomes. 18 participants were not analyzed due to incomplete data collection.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.3 Years |
| Race/Ethnicity, Customized African American or Black | 17 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Declined to identify | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 150 Participants |
| Region of Enrollment United States | 86 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 86 | 0 / 84 |
| other Total, other adverse events | 31 / 86 | 26 / 84 |
| serious Total, serious adverse events | 26 / 86 | 21 / 84 |
Outcome results
None listed