IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery

Tracking Information
First Submitted Date ICMJE	September 17, 2010
First Posted Date ICMJE	September 20, 2010
Last Update Posted Date	August 10, 2011
Study Start Date ICMJE	May 2009
Actual Primary Completion Date	May 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 17, 2010)	hemodynamic variables [ Time Frame: baseline & 2 minutes post device activation ]; hemodynamic variables (pulmonary and systemic blood pressure, central and pulmonary venous pressure, cardiac output, calculated SVR) will be collected at baseline & 2 minutes post device activation
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01205594 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 17, 2010)	left ventricular performance [ Time Frame: baseline &2 minutes after activation of the device ]; left ventricular performance (including estimates of LVEDV, LVESV, EF, FAC, etc.) will be assessed using TEE.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery
Official Title ICMJE	IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery
Brief Summary	Briefly, after the induction of anesthesia and the placement of TEE, hemodynamic variables (pulmonary and systemic blood pressure, central and pulmonary venous pressure, cardiac output, calculated SVR, etc.) will be collected. In addition, left ventricular performance (including estimates of LVEDV, LVESV, EF, FAC, etc.) will be assessed using TEE. Once these baseline data are recorded, the ITPR will be inserted in the anesthesia circuit and activated to provide -9 mmHg ETP. After the ITPR has been active for at least two minutes, the same hemodynamic and TEE data obtained above will be gathered. After the data is recorded, the ITPR will be disconnected and no further interventions will be made. In addition to the hemodynamic and echocardiographic data described above, an arterial blood gas will be obtained from the pre-existing radial artery catheter during the on- and off- states. Finally, the TEE examination will be recorded on videotape or DVD. A second echocardiographer, blinded to patient and ITPR status will review each echocardiogram and assess left ventricular performance. In addition to the data derived at the time of testing, the second echocardiographer will assess, if possible, changes in EF using Simpson's method of disks is used to calculate the LV volume. This is a proof of concept/feasibility study designed to test the primary hypothesis that use of the ITPR will result in increased systemic blood pressure and cardiac output in patients undergoing CABG surgery. The effect of the ITPR on other secondary indicators of cardiac performance will also be examined. These include but are not limited to left ventricular end diastolic volume (LVEDV), ejection fraction (EF), left ventricular end systolic volume (LVESV), and fractional area change (FAC) as assessed by echocardiography, pulmonary artery pressure, and calculated systemic vascular resistance (SVR).
Detailed Description	The 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 SVR. The end result is a device that simultaneously improves cardiac output by increasing LVEDP/LVEDV and decreasing SVR while increasing coronary perfusion pressure by increasing blood pressure and decreasing LVESP/LVESV.1-8
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	Coronary Artery Disease
Intervention ICMJE	Device: ITPR; the ITPR will be inserted in the anesthesia circuit and activated to provide -10 mmHg ETP.
Study Arms	Experimental: ITPR device; the ITPR will be inserted in the anesthesia circuit and activated to provide -10 mmHg ETP.; Intervention: Device: ITPR
Publications *	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.; 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.; 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.; 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.; 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.; 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.; 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. Epub 2006 Aug 9.; 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. Epub 2005 Aug 1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 17, 2010)	20
Original Actual Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Actual Primary Completion Date	May 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 1. patients presenting for elective CABG with planned intraoperative TEE 2. age 18 years of age and older 3. informed consent has been obtained Exclusion Criteria: 1. Patients with planned valve surgery (valve or CABG + valve) 2. patients with a contraindication to transesophageal echocardiography (TEE); including patients with extensive esophageal or gastric disease. Relative contraindications include esophageal varices, Barrett's esophagus, Zenker's diverticulum, and postradiation therapy of the esophageal area. 3. patients requiring IABP or VAD pre-operatively 4. emergent CABG 5. pneumothorax 6. hemothorax 7. uncontrolled bleeding 8. uncontrolled hypertension defined as SBP > 180 mmHg at the time of surgery
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01205594
Other Study ID Numbers ICMJE	14296
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Edward C. Nemergut MD, University of Virginia Anesthesiology
Study Sponsor ICMJE	University of Virginia
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Edward C Nemergut, MD University of Virginia Anesthesiology
PRS Account	University of Virginia
Verification Date	August 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP