Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Minimally invasive hemodynamic monitoring

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic Liver Surgery; Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring	Device: Minimally invasive hemodynamic monitoring; Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
Laparoscopic Pancreas Surgery; Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring	Device: Minimally invasive hemodynamic monitoring; Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
Open Liver Surgery; Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring	Device: Minimally invasive hemodynamic monitoring; Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
Open Pancreas Surgery; Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring	Device: Minimally invasive hemodynamic monitoring; Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ryan Swan, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Perioperative Fluid Management; Hemodynamic Monitoring; Hepatobiliary and Pancreas Surgery
• Other Study ID Numbers: 03-14-03E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes