Esophageal DiseasesPhase 4NCT00526331
Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
A Phase 4 study testing Vigileo Monitor and FloTrac Sensor in people with Esophageal Diseases and Gastrointestinal Diseases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Diseases, Gastrointestinal Diseases, Disorder of the Genitourinary System
- What is being tested?
- Vigileo Monitor and FloTrac Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is in hospital for study indicated treatment.
- Patient is able to comply with the study procedure.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patients with an American Society of Anesthesiologists Risk Score >= 3.
- Lee Risk Index >/= 2 (Hypertension and Pre-diabetic metabolic state).
- Patient must be 40 kg or heavier.
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- Patient has consented to be in the trial.
- Patient's height and weight can be accurately obtained prior to study start.
- Patient's ability to undergo major surgery with an anticipated blood loss > 500 ml.
Who cannot join
- Patients with contraindications for the placement of radial, femoral, or other arterial cannula.
- Patients with contraindications for the placement of central venous cannula.
- Patients being treated with an intra-aortic balloon pump.
- Patients with aortic valve regurgitation.
- Patients with atrial fibrillation.
- Female patients with a known pregnancy confirmed by urine pregnancy test.
- Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
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.
Read the 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 M.D. Anderson.
- Conditions
- Esophageal Diseases, Gastrointestinal Diseases, Disorder of the Genitourinary System, Gynecologic Diseases, Kidney Diseases, Liver Diseases
- Being tested
- Vigileo Monitor, FloTrac Sensor
- Keywords
- Perioperative Therapy, Perioperative Hydration, Arterial Pressure Based Cardiac Output, Vigileo Monitor, FloTrac Sensor, Fluid Volume, APCO
- Medical subject headings
- Esophageal Diseases, Gastrointestinal Diseases, Urogenital Diseases, Genital Diseases, Female, Kidney Diseases, Liver Diseases, Pancreatic Diseases, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigileo MonitorDevice
Study Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group.
FloTrac SensorDevice
Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery. Receives: Device: Vigileo Monitor; Device: FloTrac Sensor |
| Control Group | Experimental | FloTrac Sensor + Vigileo Monitor only used for data collection during surgery; Standard of Care to decide fluid amount. Receives: Device: Vigileo Monitor; Device: FloTrac Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay (LOS) by Participant
Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.
Measured: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Gabriel Mena, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526331
- Sponsor's protocol ID
- 2007-0231
- Status last verified
- Dec 2011
- First submitted
- 5 Sep 2007
- Last updated
- 16 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
- ClinicalTrials.gov ID
- NCT00526331
- Acronym / sponsor ID
- 2007-0231
- Conditions
- Esophageal Diseases, Gastrointestinal Diseases, Disorder of the Genitourinary System, Gynecologic Diseases, Kidney Diseases, Liver Diseases
- Keywords
- Perioperative Therapy, Perioperative Hydration, Arterial Pressure Based Cardiac Output, Vigileo Monitor, FloTrac Sensor, Fluid Volume, APCO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 16 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 M.D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Vigileo Monitor, Device: FloTrac SensorFloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery. |
| Control Group | Experimental | Device: Vigileo Monitor, Device: FloTrac SensorFloTrac Sensor + Vigileo Monitor only used for data collection during surgery; Standard of Care to decide fluid amount. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is in hospital for study indicated treatment.
- Patient is able to comply with the study procedure.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patients with an American Society of Anesthesiologists Risk Score >= 3.
- Lee Risk Index >/= 2 (Hypertension and Pre-diabetic metabolic state).
Key exclusion criteria (7 listed)
- Patients with contraindications for the placement of radial, femoral, or other arterial cannula.
- Patients with contraindications for the placement of central venous cannula.
- Patients being treated with an intra-aortic balloon pump.
- Patients with aortic valve regurgitation.
- Patients with atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigileo MonitorStudy Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group. | Device | Control Group, Study Group |
| FloTrac SensorDevice connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery. | Device | Control Group, Study Group |
Primary outcome
Length of Hospital Stay (LOS) by Participant
Time frame: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)
Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Mena, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vigileo Monitor and FloTrac Sensor in people with Esophageal Diseases and Gastrointestinal Diseases, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (LOS) by Participant (time frame: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2012.