Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354211
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2006-07-18
Brief Title:
Using Minimally Invasive Cardiac Output Data vs Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically Unstable
Sponsor:
Edwards Lifesciences
Organization:
Edwards Lifesciences
Study Overview
Official Title:
TREASURE Treatment With Minimally-Invasive Cardiac Output for Assessment of User Derived Results Evaluating Economic Benefit
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate if the continuous availability of minimally invasive cardiac output data during treatment in the intensive care unit ICU for hemodynamic instability in comparison to standard of care will shorten the time needed to stabilize the patient
The researchers hypothesize that early detection of instability improves the prognosis and treatment outcome of emergency intensive care patients with hemodynamic instability
The researchers hypothesize that early detection of instability improves the prognosis and treatment outcome of emergency intensive care patients with hemodynamic instability
Detailed Description:
Hemodynamic instability during the first 24-hours of Intensive Care Unit ICU admission is associated with increased risk of subsequent morbidity and mortality Goal-directed hemodynamic support has been successfully used in a variety of patients to improve outcome In contrast a similar therapeutic approach applied later or in patients with established multi-organ failure has no beneficial effect and may even worsen the outcome
It is conceivable that there is a window of opportunity during the phases of hemodynamic instability where therapeutic interventions have the greatest potential to influence the subsequent course of critical illness Large scale uses of therapeutic protocols for early intervention have been hampered by logistic problems The burden of installing invasive hemodynamic monitoring and protocols is labor intensive and requires a continuous presence of personnel with a thorough understanding of complex physiology Various techniques have been introduced for monitoring cardiac output stroke volume or their surrogates The disadvantage of these technologies so far have included user dependence of measurements results need for calibration and limitations in applicability Edwards Lifesciences has developed a new algorithm for the determination of cardiac output using arterial pressure data The FloTrac system which includes the FloTrac sensor and Vigileo monitor is utilized to capture the arterial pressure-based cardiac output measurement which will be hereinafter referred to as APCO Arterial Pressure Cardiac Output This system uses an existing arterial catheter placed in the femoral or radial artery and does not require calibration by an external reference method We hypothesize that using the FloTrac system to continuously monitor cardiac output in addition to traditional vital signs cardiovascular instability will be identified earlier and result in earlier intervention In addition following earlier diagnosis more precise intervention will be available If this can be achieved patients will likely show better outcomes by reduced length of hospital stay ICU time Mechanical Ventilation time incidence of renal compromise and other related morbiditymortality and need less ICUresources
It is conceivable that there is a window of opportunity during the phases of hemodynamic instability where therapeutic interventions have the greatest potential to influence the subsequent course of critical illness Large scale uses of therapeutic protocols for early intervention have been hampered by logistic problems The burden of installing invasive hemodynamic monitoring and protocols is labor intensive and requires a continuous presence of personnel with a thorough understanding of complex physiology Various techniques have been introduced for monitoring cardiac output stroke volume or their surrogates The disadvantage of these technologies so far have included user dependence of measurements results need for calibration and limitations in applicability Edwards Lifesciences has developed a new algorithm for the determination of cardiac output using arterial pressure data The FloTrac system which includes the FloTrac sensor and Vigileo monitor is utilized to capture the arterial pressure-based cardiac output measurement which will be hereinafter referred to as APCO Arterial Pressure Cardiac Output This system uses an existing arterial catheter placed in the femoral or radial artery and does not require calibration by an external reference method We hypothesize that using the FloTrac system to continuously monitor cardiac output in addition to traditional vital signs cardiovascular instability will be identified earlier and result in earlier intervention In addition following earlier diagnosis more precise intervention will be available If this can be achieved patients will likely show better outcomes by reduced length of hospital stay ICU time Mechanical Ventilation time incidence of renal compromise and other related morbiditymortality and need less ICUresources
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None