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This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSepâ„¢ Central Venous Oximetry Catheter, the Vigileoâ„¢ monitor, and FloTracâ„¢ 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 FloTracâ„¢ Sensor to the arterial line and the Vigileoâ„¢ 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 Vigileoâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Liver Surgery | Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring |
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| Laparoscopic Pancreas Surgery | Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring |
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| Open Liver Surgery | Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring |
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| Open Pancreas Surgery | Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive hemodynamic monitoring | Device | Use of advanced minimally invasive hemodynamic monitoring with PreSepâ„¢ Central Venous Oximetry Catheter, Vigileoâ„¢ monitor, and FloTracâ„¢ sensor for perioperative fluid management |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative complications | Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation time | Measurement of time to extubation (hours) | up to 48 hours |
| Incidence of postoperative blood transfusions | Volume of blood transfused following surgical procedure (mL) |
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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:
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The procedures will be divided by organ systems, liver and pancreas, and by method of surgery, laparoscopic versus open. Five patients will be chosen for each group for a total of 20 patients enrolled. The following procedures will be included in the study: liver resection (>2 segments), distal pancreatectomy and splenectomy, and pancreaticoduodenectomy, including robotic procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Swan, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| up to 10 days |
| Incidence of postoperative complications | Rate of pre-specified postoperative complications (number of patients affected) | up to 10 days |
| ICU length of stay | Intensive Care Unit (ICU) length of stay (days) | up to 3 days |
| Length of hospital stay | Time to discharge from hospital (days) | up to 10 days |