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Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

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ClinicalTrials.gov Identifier: NCT03612687
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
David Iannitti, Atrium Health

Study Description
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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.

Condition or disease Intervention/treatment
Cancer 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 Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of intraoperative complications [ Time Frame: Intraoperative period ]
    Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events


Secondary Outcome Measures :
  1. Extubation time [ Time Frame: up to 48 hours ]
    Measurement of time to extubation (hours)

  2. Incidence of postoperative blood transfusions [ Time Frame: up to 10 days ]
    Volume of blood transfused following surgical procedure (mL)

  3. Incidence of postoperative complications [ Time Frame: up to 10 days ]
    Rate of pre-specified postoperative complications (number of patients affected)

  4. ICU length of stay [ Time Frame: up to 3 days ]
    Intensive Care Unit (ICU) length of stay (days)

  5. Length of hospital stay [ Time Frame: up to 10 days ]
    Time to discharge from hospital (days)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612687


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Ryan Swan, MD Atrium Health
More Information
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Responsible Party: David Iannitti, Chief, HPB Surgery, Atrium Health
ClinicalTrials.gov Identifier: NCT03612687    
Other Study ID Numbers: 03-14-03E
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by David Iannitti, Atrium Health:
Hemodynamic Monitoring
Perioperative Fluid Management
Hepatobiliary and Pancreas Surgery