Cancer
Conditions
Keywords
Hemodynamic Monitoring, Perioperative Fluid Management, Hepatobiliary and Pancreas Surgery
Brief summary
This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.
Detailed description
Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.
Interventions
Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\. Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy.
Exclusion criteria
1. Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas 2. Suspected inability to comply with trial procedures or understand consent 3. Employee at the investigational center, relative or spouse of the investigators 4. Patients incarcerated at the time of surgery 5. Females who are pregnant or breastfeeding 6. Planned use of Cell Saver during surgical procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative complications | Intraoperative period | Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | up to 48 hours | Measurement of time to extubation (hours) |
| Incidence of postoperative blood transfusions | up to 10 days | Volume of blood transfused following surgical procedure (mL) |
| Incidence of postoperative complications | up to 10 days | Rate of pre-specified postoperative complications (number of patients affected) |
| ICU length of stay | up to 3 days | Intensive Care Unit (ICU) length of stay (days) |
| Length of hospital stay | up to 10 days | Time to discharge from hospital (days) |
Countries
United States
Outcome results
None listed