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Device
ITPR for Heart Surgery
Phase 2
Waitlist Available
Led By Julie L Huffmyer, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
patients presenting for elective off-pump CABG
age 18 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours after surgery
Awards & highlights
Study Summary
This trial is testing whether a machine that regulates pressure can help heart surgery patients by reducing the amount of fluids and drugs they need.
Who is the study for?
This trial is for adults over 18 years old who are scheduled for elective off-pump coronary artery bypass surgery (Off-CABG) and have given informed consent. It's not open to those needing heart pump support before surgery, with conditions like pneumothorax, uncontrolled bleeding or hypertension, or if they're having emergency CABG.Check my eligibility
What is being tested?
The study tests if the CirQlator TM Intrathoracic Pressure Regulator (ITPR) can help patients maintain better blood pressure and cardiac output during Off-CABG surgery compared to no ITPR use. Patients will be randomly assigned to either receive ITPR or not, with both groups receiving standardized anesthesia.See study design
What are the potential side effects?
While specific side effects of the ITPR aren't listed in this summary, potential risks may include complications related to changes in intrathoracic pressure such as discomfort or respiratory issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a heart bypass surgery without using a heart-lung machine.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
hemodynamic changes
Secondary outcome measures
IV fluids administered
cardiac ischemia
diuretics administered
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ITPRExperimental Treatment1 Intervention
• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).
Group II: No interventionActive Control1 Intervention
No intervention will be performed in this control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ITPR
2009
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,235,973 Total Patients Enrolled
Julie L Huffmyer, MDPrincipal InvestigatorUVA Anesthesiology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have blood in the chest outside the lung.I am scheduled for a heart bypass surgery without using a heart-lung machine.I am scheduled for a heart bypass surgery using a heart-lung machine.I am 18 years old or older.I have had emergency coronary artery bypass surgery.You need an intra-aortic balloon pump or ventricular assist device before surgery.I have had a collapsed lung.I am currently experiencing uncontrolled bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: No intervention
- Group 2: ITPR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study still looking for participants?
"Unfortunately, this particular clinical trial is not looking for new patients at the moment. However, there are 29 other trials with active recruitment drives happening right now."
Answered by AI
Could you explain the risks associated with ITPR exposure?
"While there is some clinical evidence backing ITPR's safety, it only received a score of 2 because efficacy has not been proven in any prior trials."
Answered by AI
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