2014-05
2014-09
2014-11
20
NCT03612687
Wake Forest University Health Sciences
Wake Forest University Health Sciences
OBSERVATIONAL
Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2014-05-22 | N/A | 2022-04-20 |
2018-07-27 | N/A | 2022-04-27 |
2018-08-02 | N/A | 2018-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
: Laparoscopic Liver Surgery Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring | DEVICE: Minimally invasive hemodynamic monitoring
|
: Laparoscopic Pancreas Surgery Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring | DEVICE: Minimally invasive hemodynamic monitoring
|
: Open Liver Surgery Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring | DEVICE: Minimally invasive hemodynamic monitoring
|
: Open Pancreas Surgery Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring | DEVICE: Minimally invasive hemodynamic monitoring
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Incidence of intraoperative complications | Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events | Intraoperative period |
Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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