What is the mechanism of action of this treatment?

Common treatments for Coronary Artery Bypass Surgery (CABG) focus on improving hemodynamic stability, which is crucial for patient outcomes. The CirQlator TM Intrathoracic Pressure Regulator (ITPR) works by regulating intrathoracic pressure, thereby enhancing cardiac output and stabilizing blood pressure. This mechanism is vital as it reduces the need for vasopressors and intravenous fluids, minimizing complications and improving recovery. Other treatments, such as inotropes and vasodilators, also aim to optimize cardiac function and blood flow, ensuring adequate tissue perfusion and reducing the risk of ischemic events during and after surgery.

What side effects are associated with this type of intervention?

Common treatments for improving hemodynamic stability in Coronary Artery Bypass Graft (CABG) surgery include the use of vasopressors like norepinephrine and epinephrine, as well as fluid management strategies. Known side effects of vasopressors include arrhythmias, increased myocardial oxygen consumption, and peripheral ischemia. Fluid management can lead to fluid overload, pulmonary edema, and electrolyte imbalances. The CirQlator TM Intrathoracic Pressure Regulator (ITPR), which regulates intrathoracic pressure to improve hemodynamic stability, may reduce the need for vasopressors and fluid boluses, potentially minimizing these side effects. However, specific side effects related to ITPR use are not well-documented.

What prior FDA approvals exist?

FDA-approved treatments for improving hemodynamic stability during Coronary Artery Bypass Surgery (CABG) include drugs like milrinone and nesiritide. Milrinone is a phosphodiesterase inhibitor that helps increase cardiac output and reduce vascular resistance, while nesiritide is a recombinant form of B-type natriuretic peptide that aids in vasodilation and reducing cardiac preload and afterload. Both drugs have been studied for their efficacy in managing hemodynamic parameters in high-risk CABG patients. Devices like the CirQlator TM Intrathoracic Pressure Regulator (ITPR), which regulate intrathoracic pressure to enhance hemodynamic stability, represent a novel approach in this area.

What other types of research exist?

Promising alternatives to the CirQlator TM ITPR for CABG patients include: 1) Enhanced External Counterpulsation (EECP) - a non-invasive therapy that improves blood flow and cardiac function. 2) Impella Heart Pump - a percutaneous ventricular assist device that supports cardiac output during surgery. 3) Intra-aortic Balloon Pump (IABP) - a mechanical device that increases myocardial oxygen perfusion and cardiac output. These alternatives focus on improving hemodynamic stability and cardiac function during and after surgery.

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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

Must not have

Patients with planned on pump CABG

hemothorax

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after surgery

Awards & highlights

Summary

This trial tests a device called CirQlator that helps improve blood flow and pressure by creating a vacuum in the chest. It is aimed at patients undergoing heart surgery who need better ways to maintain heart function. The device works by helping more blood return to the heart and reducing resistance in blood vessels. The CirQlator is a novel, noninvasive device intended to increase heart performance and blood pressure by generating a gentle vacuum in the chest.

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.

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.

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

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I am scheduled for a heart bypass surgery without using a heart-lung machine.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a heart bypass surgery using a heart-lung machine.

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I have blood in the chest outside the lung.

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I have had emergency coronary artery bypass surgery.

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I have had a collapsed lung.

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I am currently experiencing uncontrolled bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

hemodynamic changes

Secondary study objectives

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Bypass Surgery (CABG) focus on improving hemodynamic stability, which is crucial for patient outcomes. The CirQlator TM Intrathoracic Pressure Regulator (ITPR) works by regulating intrathoracic pressure, thereby enhancing cardiac output and stabilizing blood pressure. This mechanism is vital as it reduces the need for vasopressors and intravenous fluids, minimizing complications and improving recovery. Other treatments, such as inotropes and vasodilators, also aim to optimize cardiac function and blood flow, ensuring adequate tissue perfusion and reducing the risk of ischemic events during and after surgery.

[Effect of transmyocardial laser revascularization on the myocardium in the early postoperative period].The effect of preconditioning (ischemic and pharmacological) on myocardial necrosis following coronary artery bypass graft surgery.

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Who is running the clinical trial?

University of VirginiaLead Sponsor

771 Previous Clinical Trials

1,284,267 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

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