Status:

UNKNOWN

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

Lead Sponsor:

University of Virginia

Conditions:

CABG

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 standardize...

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01205620

Start Date

August 1 2010

Last Update

September 20 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Virginia Health System

Charlottesville, Virginia, United States, 22908