Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

Study Overview
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Brief Summary
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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 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
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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.

Official Title
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Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study

Conditions
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Cancer

Intervention / Treatment
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* Device: Minimally invasive hemodynamic monitoring


Participation Criteria
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Eligibility Criteria
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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: Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas Suspected inability to comply with trial procedures or understand consent Employee at the investigational center, relative or spouse of the investigators Patients incarcerated at the time of surgery Females who are pregnant or breastfeeding Planned use of Cell Saver during surgical procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic Liver Surgery<br>Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring | Device: Minimally invasive hemodynamic monitoring<br>* Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management<br>|
| Laparoscopic Pancreas Surgery<br>Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring | Device: Minimally invasive hemodynamic monitoring<br>* Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management<br>|
| Open Liver Surgery<br>Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring | Device: Minimally invasive hemodynamic monitoring<br>* Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management<br>|
| Open Pancreas Surgery<br>Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring | Device: Minimally invasive hemodynamic monitoring<br>* Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative complications | Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic Monitoring, Perioperative Fluid Management, Hepatobiliary and Pancreas Surgery