Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593717
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-03
Brief Title:
Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation VV ECMO - HemodynamECMOnitoring-VV Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Techniques for Hemodynamic Monitoring and Prediction of Fluid Responsiveness in Patients Undergoing Venovenous Extracorporeal Membrane Oxygenation - a Prospective Diagnostic Accuracy Study HemodynamECMOnitoring-VV Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In extracorporeal membrane oxygenation ECMO blood is drawn out of the body via tubes oxygenated in an artificial lung and then pumped back into the blood vessels This allows the supply of oxygen-rich blood to the organs brain heart lungs kidneys liver intestines etc to be maintained
Continuous monitoring of cardiac function and circulatory status blood pressure blood flow to organs is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions Various devices are routinely used for this task However in the specific situation of ECMO treatment the measurements of these devices could be affected due to the artificial circulation outside the body
The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment
Continuous monitoring of cardiac function and circulatory status blood pressure blood flow to organs is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions Various devices are routinely used for this task However in the specific situation of ECMO treatment the measurements of these devices could be affected due to the artificial circulation outside the body
The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment
Detailed Description:
Hemodynamic monitoring and tests for fluid responsiveness are cornerstones of intensive care medicine
Generally hemodynamic measurements can be obtained for instance with the following methods pulmonary artery catheter transthoracic echocardiography TTE esophageal doppler transpulmonary thermodilution pulse contour analysis and bioreactance amongst others
Maneuvers for assessing volume responsiveness include passive leg raising PLR respiratory pulse pressure variation PPV stroke volume variation SVV inferior vena cava ultrasound IVC and end-inspiratory or end-expiratory occlusion tests
While these commonly used methods of hemodynamic assessment have been validated in various clinical scenarios data are lacking in the setting of venovenous extracorporeal membrane oxygenation VV ECMO VV ECMO is commonly used for respiratory support in patients with severe acute respiratory failure Blood is usually drained from a femoral vein pumped through an oxygenator where it is oxygenated and decarboxylated and thereafter reinfused into the patient via a central venous most commonly jugular return cannula Theoretically the artificial circulation with its blood drainage and return flows may interfere with common hemodynamic monitoring techniques and lead to erroneous measurements
The aim of this study therefore is to validate select techniques of hemodynamic monitoring and assessment of fluid responsiveness in patients on VV ECMO
In the context of this study the performance of different hemodynamic monitoring tools and techniques for predicting fluid responsiveness will be compared
Generally hemodynamic measurements can be obtained for instance with the following methods pulmonary artery catheter transthoracic echocardiography TTE esophageal doppler transpulmonary thermodilution pulse contour analysis and bioreactance amongst others
Maneuvers for assessing volume responsiveness include passive leg raising PLR respiratory pulse pressure variation PPV stroke volume variation SVV inferior vena cava ultrasound IVC and end-inspiratory or end-expiratory occlusion tests
While these commonly used methods of hemodynamic assessment have been validated in various clinical scenarios data are lacking in the setting of venovenous extracorporeal membrane oxygenation VV ECMO VV ECMO is commonly used for respiratory support in patients with severe acute respiratory failure Blood is usually drained from a femoral vein pumped through an oxygenator where it is oxygenated and decarboxylated and thereafter reinfused into the patient via a central venous most commonly jugular return cannula Theoretically the artificial circulation with its blood drainage and return flows may interfere with common hemodynamic monitoring techniques and lead to erroneous measurements
The aim of this study therefore is to validate select techniques of hemodynamic monitoring and assessment of fluid responsiveness in patients on VV ECMO
In the context of this study the performance of different hemodynamic monitoring tools and techniques for predicting fluid responsiveness will be compared
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