Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2018 |
| Start Date: | May 2014 |
| End Date: | November 2014 |
Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study
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.
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.
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.
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.
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
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