Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526331
Status:
COMPLETED
Last Update Posted:
2012-01-16
First Post:
2007-09-05
Brief Title:
Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
Status:
COMPLETED
Status Verified Date:
2011-12
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 determine whether the early identification and more precise intervention of operating room OR patient fluid administration optimization using arterial pressure-based cardiac output APCO yields comparable patient outcome as fluid administration optimization using a global standard care method
Detailed Description:
THE EDWARDS VIGILEO MONITOR
The Vigileo monitor measures the amount of blood the heart pumps through the body
SCREENING TEST
Before you can begin this study you will have a screening test to help the doctor decide if you are eligible to take part in this study Women who are able to have children must have a negative urine pregnancy test
STUDY GROUP
If you are found to be eligible to take part in this study you will be randomly assigned as in the flip of a coin to either the Control Group or the Study Group You will have an equal chance of being assigned to either group You will not know to which group you have been assigned
STUDY PARTICIPATION
You will have a arterial catheter small plastic tube inserted into an artery inside your wrist at the beginning of surgery This is used routinely even in patients not taking part in the study to measure your blood pressure more accurately rather than with a blood pressure cuff It is inserted after you receive general anesthesia numbing medicine so you should feel no pain If it is inserted while you are awake based on the judgment of your anesthesiologist then local anesthesia will be given to you to reduce discomfort
If your doctors decide that an arterial catheter is not required as part of your routine medical care during your surgery they will not place one for study purposes only In that situation you will be removed from the study and your medical care will continue as planned by your doctors
If the catheter is placed the Vigileo monitor will be connected to the catheter and readings will be taken during the surgery It will be disconnected at the end of surgery
If you are in the Study Group your doctor will use the monitor and routine vital sign measurement to decide how much fluid to give you during surgery
If you are in the Control Group your doctor will not know the information being collected by the monitor as it will be collected and compared to the information collected from participants in the Study Group The amount of fluid you received during surgery will be decided by routine vital sign measurement as is standard of care
ESOPHAGEAL DOPPLER
Regardless of study group assignment during your surgery researchers will also connect an esophageal doppler which will also collect data on fluid volume
The esophageal doppler is a thin tube-like device that is placed in your throat while you are asleep This is used routinely by doctors to assist in the administration of fluids during surgery
The information from the doppler will be compared to the information collected from the Vigileo monitor The esophageal doppler measures blood flow through your heart by ultrasound waves
LENGTH OF STUDY
You will be considered off study once you leave the recovery room
FOLLOW-UP
Researchers will be collecting information on your progress during and after surgery including when you are allowed to leave the hospital Your medical records will be reviewed after surgery and up to 6 months after surgery to see how you are doing and if you have had any medical problems The kind of information researchers will be collecting is the amount of time you were in the intensive care if any amount of time in the hospital any complications or problems you may have had how well you organs are functioning and general health information
This is an investigational study The Vigileo Monitor and esophageal doppler are FDA approved and commercially available for volume monitoring The comparison of the monitor and doppler is investigational
Up to 218 patients will be enrolled in this multi-center study Up to 66 will be enrolled at MD Anderson
The Vigileo monitor measures the amount of blood the heart pumps through the body
SCREENING TEST
Before you can begin this study you will have a screening test to help the doctor decide if you are eligible to take part in this study Women who are able to have children must have a negative urine pregnancy test
STUDY GROUP
If you are found to be eligible to take part in this study you will be randomly assigned as in the flip of a coin to either the Control Group or the Study Group You will have an equal chance of being assigned to either group You will not know to which group you have been assigned
STUDY PARTICIPATION
You will have a arterial catheter small plastic tube inserted into an artery inside your wrist at the beginning of surgery This is used routinely even in patients not taking part in the study to measure your blood pressure more accurately rather than with a blood pressure cuff It is inserted after you receive general anesthesia numbing medicine so you should feel no pain If it is inserted while you are awake based on the judgment of your anesthesiologist then local anesthesia will be given to you to reduce discomfort
If your doctors decide that an arterial catheter is not required as part of your routine medical care during your surgery they will not place one for study purposes only In that situation you will be removed from the study and your medical care will continue as planned by your doctors
If the catheter is placed the Vigileo monitor will be connected to the catheter and readings will be taken during the surgery It will be disconnected at the end of surgery
If you are in the Study Group your doctor will use the monitor and routine vital sign measurement to decide how much fluid to give you during surgery
If you are in the Control Group your doctor will not know the information being collected by the monitor as it will be collected and compared to the information collected from participants in the Study Group The amount of fluid you received during surgery will be decided by routine vital sign measurement as is standard of care
ESOPHAGEAL DOPPLER
Regardless of study group assignment during your surgery researchers will also connect an esophageal doppler which will also collect data on fluid volume
The esophageal doppler is a thin tube-like device that is placed in your throat while you are asleep This is used routinely by doctors to assist in the administration of fluids during surgery
The information from the doppler will be compared to the information collected from the Vigileo monitor The esophageal doppler measures blood flow through your heart by ultrasound waves
LENGTH OF STUDY
You will be considered off study once you leave the recovery room
FOLLOW-UP
Researchers will be collecting information on your progress during and after surgery including when you are allowed to leave the hospital Your medical records will be reviewed after surgery and up to 6 months after surgery to see how you are doing and if you have had any medical problems The kind of information researchers will be collecting is the amount of time you were in the intensive care if any amount of time in the hospital any complications or problems you may have had how well you organs are functioning and general health information
This is an investigational study The Vigileo Monitor and esophageal doppler are FDA approved and commercially available for volume monitoring The comparison of the monitor and doppler is investigational
Up to 218 patients will be enrolled in this multi-center study Up to 66 will be enrolled at MD Anderson
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