Hemodynamic Instability
Conditions
Brief summary
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
Interventions
DEVICEHemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor
Subjects with planned monitoring with a pulmonary artery catheter in the operating room, will be monitored with the above listed devices.
Sponsors
Becton, Dickinson and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Age ≥ 18 years 3. Planned monitoring with a pulmonary artery catheter 4. Patient scheduled to undergo cardiac or liver transplant surgery lasting \> 2 hours 5. Additional criteria for Sub-Cohort A (RVF) 1. Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE) 2. Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure 6. Additional criteria for Sub-Cohort B (CAI) 1. Age ≥ 45 years 2. Planned cardiac surgery with Cardiopulmonary Bypass (CPB) 3. Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period 4. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease
Exclusion criteria
1. Inability to provide informed consent 2. Pregnancy as confirmed per EMR 3. Patients deemed not suitable for the study at the discretion of the Investigator 4. Participation in another study that clinically interferes with the current study 5. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices | Up to 72 hours of device data collection during surgery and ICU | Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development. |
Countries
United States
Contacts
CONTACTCristina Johnson
Outcome results
None listed