Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery
20. april 2022 opdateret af: Wake Forest University Health Sciences
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
20
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28204
- Carolinas Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Laparoscopic Liver Surgery
Laparoscopic Liver Surgical Procedures with 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
|
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
|
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
|
Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of intraoperative complications
Tidsramme: Intraoperative period
|
Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events
|
Intraoperative period
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Extubation time
Tidsramme: up to 48 hours
|
Measurement of time to extubation (hours)
|
up to 48 hours
|
|
Incidence of postoperative blood transfusions
Tidsramme: up to 10 days
|
Volume of blood transfused following surgical procedure (mL)
|
up to 10 days
|
|
Incidence of postoperative complications
Tidsramme: up to 10 days
|
Rate of pre-specified postoperative complications (number of patients affected)
|
up to 10 days
|
|
ICU length of stay
Tidsramme: up to 3 days
|
Intensive Care Unit (ICU) length of stay (days)
|
up to 3 days
|
|
Length of hospital stay
Tidsramme: up to 10 days
|
Time to discharge from hospital (days)
|
up to 10 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ryan Swan, MD, Wake Forest University Health Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2014
Primær færdiggørelse (Faktiske)
1. september 2014
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
22. maj 2014
Først indsendt, der opfyldte QC-kriterier
27. juli 2018
Først opslået (Faktiske)
2. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. april 2022
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 03-14-03E
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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