IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01205620
First received: September 17, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

Participants undergoing Off-CABG will be randomized 1:1 to one of the following groups:

  • treatment with CirQlator TM Intrathoracic Pressure Regulator (ITPR)
  • no ITPR .Anesthesia will be standardized for both groups. The groups will be compared based on the differences in vasopressor use, the number and amount (in milliliters) of intravenous fluid boluses required and hemodynamic changes noted, including systemic blood pressure, pulmonary arterial pressure, pulse pressure, heart rate (recorded most reliably from the arterial line), cardiac output (CO), cardiac index (CI), mixed venous oxygen saturation (SVO2), SVR, pulmonary vascular resistance (PVR), and stroke volume (SV).

Specifically, we will compare the groups based on the mean number of intravenous fluid boluses, mean amount of norepinephrine and epinephrine infusion required, the number of recorded systolic blood pressures < 90 mmHg, and number of CI < 2.0 L/min/m2. We will also compare the number of times the surgeon must reposition the heart for treatment of hypotension, and ascertain whether the ITPR will help patients tolerate the cardiac displacement better, thus decreasing the time required to complete the bypass graft anastamosis. ECG will be monitored intraoperatively for signs of ischemia including ST changes, greater than 1mm depression or elevation. Postoperatively, we will record the need for and amount of diuretic required.

We hypothesize that in this pilot study, patients undergoing OPCAB who are treated with CirQlator TM Intrathoracic Pressure Regulator (ITPR) will achieve higher blood pressures and cardiac output and require less intravenous fluids and vasopressor administration than patients managed without the ITPR.


Condition Intervention Phase
CABG
Device: ITPR
Other: No intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • hemodynamic changes [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    hemodynamic changes noted, including systemic blood pressure, pulmonary arterial pressure, pulse pressure, heart rate (recorded most reliably from the arterial line), cardiac output (CO), cardiac index (CI), mixed venous oxygen saturation (SVO2), SVR, pulmonary vascular resistance (PVR), and stroke volume (SV).


Secondary Outcome Measures:
  • use of vasopressors [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    the specific drug and dos will be comparedage used during surgery

  • IV fluids administered [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    the type & amount of fluid administered suring surgery will be compared

  • the number of times the surgeon must reposition the heart for treatment of hypotension [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    the number of times the surgeon must reposition the heart for treatment of hypotension will be compared, and ascertain whether the ITPR will help patients tolerate the cardiac displacement better, thus decreasing the time required to complete the bypass graft anastamosis.

  • cardiac ischemia [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    ECG will be monitored intraoperatively for signs of ischemia including ST changes, greater than 1mm depression or elevation.

  • diuretics administered [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    Postoperatively, we will record the need for and amount of diuretic required.for the first 48 hours post-operatively.


Estimated Enrollment: 30
Study Start Date: August 2010
Arms Assigned Interventions
Experimental: ITPR
• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).
Device: ITPR
• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).
No Intervention: No intervention
No intervention will be performed in this control group
Other: No intervention
No intervention will be performed in the control group

Detailed Description:

A new method to improve cardiac performance during OPCAB surgery is needed in order to avoid the administration of large amounts of intravenous volume, reduce vasopressor medications, and thus improve cardiac function and reduce the need for postoperative diuresis.

The CirQlator TM Intrathoracic Pressure Regulator (ITPR) is an FDA-approved device intended to increase circulation and blood pressure in hypovolemic and cardiogenic shock. The device is inserted within a standard respiratory circuit between the patient and the ventilator. It functions by decreasing intrathoracic pressure during the expiratory phase to subatmospheric levels after each positive pressure ventilation. The decrease in intrathoracic pressure creates a vacuum within the thorax relative to the rest of the body thereby enhancing blood return to the heart and consequently increasing cardiac output and blood pressure. Activation of the device is also accompanied by a decrease in systemic vascular resistance (SVR). The end result is a device that simultaneously improves cardiac output by increasing preload and decreasing systemic vascular resistance (SVR) while increasing coronary perfusion pressure by increasing blood pressure and decreasing left ventricular end systolic pressure and volume (LVESP/LVESV).7-14

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients presenting for elective off-pump CABG age 18 years of age and older informed consent has been obtained

Exclusion Criteria:

  • Patients with planned on pump CABG patients requiring IABP or VAD pre-operatively emergent CABG pneumothorax hemothorax uncontrolled bleeding uncontrolled hypertension defined as SBP > 180 mmHg at the time of surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205620

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Julie L Huffmyer, MD UVA Anesthesiology
  More Information

Publications:

Responsible Party: Julie L. Huffmeyer, MD, UVA anesthehesiology
ClinicalTrials.gov Identifier: NCT01205620     History of Changes
Other Study ID Numbers: 15084
Study First Received: September 17, 2010
Last Updated: September 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
CABG

ClinicalTrials.gov processed this record on July 26, 2014