NCT01205620

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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
Last Updated

September 20, 2010

Status Verified

September 1, 2010

First QC Date

September 17, 2010

Last Update Submit

September 17, 2010

Conditions

CABG

Keywords

CABG

Outcome Measures

Primary Outcomes (1)

  • hemodynamic changes

    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).

    during surgery

Secondary Outcomes (5)

  • use of vasopressors

    during surgery

  • IV fluids administered

    during surgery

  • the number of times the surgeon must reposition the heart for treatment of hypotension

    during surgery

  • cardiac ischemia

    during surgery

  • diuretics administered

    48 hours after surgery

Study Arms (2)

ITPR

EXPERIMENTAL

• 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

No intervention

NO INTERVENTION

No intervention will be performed in this control group

Other: No intervention

Interventions

ITPRDEVICE

• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).

ITPR
No interventionOTHER

No intervention will be performed in the control group

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (14)

  • Bainbridge D, Cheng DC. Minimally invasive direct coronary artery bypass and off-pump coronary artery bypass surgery: anesthetic considerations. Anesthesiol Clin. 2008 Sep;26(3):437-52. doi: 10.1016/j.anclin.2008.03.007.

    PMID: 18765216BACKGROUND

  • Jansen EW, Grundeman PF, Mansvelt Beck HJ, Heijmen RH, Borst C. Experimental off-pump grafting of a circumflex branch via sternotomy using a suction device. Ann Thorac Surg. 1997 Jun;63(6 Suppl):S93-6. doi: 10.1016/s0003-4975(97)00357-3.

    PMID: 9203608BACKGROUND

  • Grundeman PF, Borst C, van Herwaarden JA, Mansvelt Beck HJ, Jansen EW. Hemodynamic changes during displacement of the beating heart by the Utrecht Octopus method. Ann Thorac Surg. 1997 Jun;63(6 Suppl):S88-92. doi: 10.1016/s0003-4975(97)00339-1.

    PMID: 9203607BACKGROUND

  • Nierich AP, Diephuis J, Jansen EW, Borst C, Knape JT. Heart displacement during off-pump CABG: how well is it tolerated? Ann Thorac Surg. 2000 Aug;70(2):466-72. doi: 10.1016/s0003-4975(00)01561-7.

    PMID: 10969664BACKGROUND

  • Grundeman PF. Vertical displacement of the beating heart by the Utrecht Octopus tissue stabilizer: effects on haemodynamics and coronary flow. Perfusion. 1998 Jul;13(4):229-30. doi: 10.1177/026765919801300403. No abstract available.

    PMID: 9682254BACKGROUND

  • Grundeman PF, Borst C, Verlaan CW, Meijburg H, Moues CM, Jansen EW. Exposure of circumflex branches in the tilted, beating porcine heart: echocardiographic evidence of right ventricular deformation and the effect of right or left heart bypass. J Thorac Cardiovasc Surg. 1999 Aug;118(2):316-23. doi: 10.1016/S0022-5223(99)70222-9.

    PMID: 10425005BACKGROUND

  • Lurie KG, Zielinski TM, McKnite SH, Idris AH, Yannopoulos D, Raedler CM, Sigurdsson G, Benditt DG, Voelckel WG. Treatment of hypotension in pigs with an inspiratory impedance threshold device: a feasibility study. Crit Care Med. 2004 Jul;32(7):1555-62. doi: 10.1097/01.ccm.0000131207.29081.a2.

    PMID: 15241102BACKGROUND

  • Lurie KG, Zielinski T, McKnite S, Aufderheide T, Voelckel W. Use of an inspiratory impedance valve improves neurologically intact survival in a porcine model of ventricular fibrillation. Circulation. 2002 Jan 1;105(1):124-9. doi: 10.1161/hc0102.101391.

    PMID: 11772887BACKGROUND

  • Lurie KG, Voelckel WG, Zielinski T, McKnite S, Lindstrom P, Peterson C, Wenzel V, Lindner KH, Samniah N, Benditt D. Improving standard cardiopulmonary resuscitation with an inspiratory impedance threshold valve in a porcine model of cardiac arrest. Anesth Analg. 2001 Sep;93(3):649-55. doi: 10.1097/00000539-200109000-00024.

    PMID: 11524335BACKGROUND

  • Lurie KG, Mulligan KA, McKnite S, Detloff B, Lindstrom P, Lindner KH. Optimizing standard cardiopulmonary resuscitation with an inspiratory impedance threshold valve. Chest. 1998 Apr;113(4):1084-90. doi: 10.1378/chest.113.4.1084.

    PMID: 9554651BACKGROUND

  • Yannopoulos D, McKnite S, Metzger A, Lurie KG. Intrathoracic pressure regulation improves 24-hour survival in a porcine model of hypovolemic shock. Anesth Analg. 2007 Jan;104(1):157-62. doi: 10.1213/01.ane.0000249047.80184.5a.

    PMID: 17179262BACKGROUND

  • Yannopoulos D, McKnite SH, Metzger A, Lurie KG. Intrathoracic pressure regulation for intracranial pressure management in normovolemic and hypovolemic pigs. Crit Care Med. 2006 Dec;34(12 Suppl):S495-500. doi: 10.1097/01.CCM.0000246082.10422.7E.

    PMID: 17114984BACKGROUND

  • Yannopoulos D, Metzger A, McKnite S, Nadkarni V, Aufderheide TP, Idris A, Dries D, Benditt DG, Lurie KG. Intrathoracic pressure regulation improves vital organ perfusion pressures in normovolemic and hypovolemic pigs. Resuscitation. 2006 Sep;70(3):445-53. doi: 10.1016/j.resuscitation.2006.02.005. Epub 2006 Aug 9.

    PMID: 16901611BACKGROUND

  • Yannopoulos D, Nadkarni VM, McKnite SH, Rao A, Kruger K, Metzger A, Benditt DG, Lurie KG. Intrathoracic pressure regulator during continuous-chest-compression advanced cardiac resuscitation improves vital organ perfusion pressures in a porcine model of cardiac arrest. Circulation. 2005 Aug 9;112(6):803-11. doi: 10.1161/CIRCULATIONAHA.105.541508. Epub 2005 Aug 1.

    PMID: 16061732BACKGROUND

Study Officials

  • Julie L Huffmyer, MD

    UVA Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

August 1, 2010

Last Updated

September 20, 2010

Record last verified: 2010-09

Locations

US(1)