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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery for reporting.

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 more

Trial 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

ITPR (Device) Clinical Trial Eligibility Overview. Trial Name: NCT01205620 — Phase 2
Coronary Artery Bypass Surgery Research Study Groups: No intervention, ITPR
Coronary Artery Bypass Surgery Clinical Trial 2023: ITPR Highlights & Side Effects. Trial Name: NCT01205620 — Phase 2
ITPR (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01205620 — Phase 2

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
Recent research and studies
~2 spots leftby Mar 2025