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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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908