Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-21 @ 6:02 AM
Study NCT ID:
NCT01205620
Status:
UNKNOWN
Last Update Posted:
2010-09-20
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-09-17', 'studyFirstSubmitDate': '2010-09-17', 'studyFirstSubmitQcDate': '2010-09-17', 'lastUpdatePostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemodynamic changes', 'timeFrame': 'during surgery', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'use of vasopressors', 'timeFrame': 'during surgery', 'description': 'the specific drug and dos will be comparedage used during surgery'}, {'measure': 'IV fluids administered', 'timeFrame': 'during surgery', 'description': 'the type \\& amount of fluid administered suring surgery will be compared'}, {'measure': 'the number of times the surgeon must reposition the heart for treatment of hypotension', 'timeFrame': 'during surgery', 'description': '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.'}, {'measure': 'cardiac ischemia', 'timeFrame': 'during surgery', 'description': 'ECG will be monitored intraoperatively for signs of ischemia including ST changes, greater than 1mm depression or elevation.'}, {'measure': 'diuretics administered', 'timeFrame': '48 hours after surgery', 'description': 'Postoperatively, we will record the need for and amount of diuretic required.for the first 48 hours post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CABG'], 'conditions': ['CABG']}, 'referencesModule': {'references': [{'pmid': '18765216', 'type': 'BACKGROUND', 'citation': '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': '9203608', 'type': 'BACKGROUND', 'citation': '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': '9203607', 'type': 'BACKGROUND', 'citation': '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': '10969664', 'type': 'BACKGROUND', 'citation': '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': '9682254', 'type': 'BACKGROUND', 'citation': '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': '10425005', 'type': 'BACKGROUND', 'citation': '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': '15241102', 'type': 'BACKGROUND', 'citation': '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': '11772887', 'type': 'BACKGROUND', 'citation': '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': '11524335', 'type': 'BACKGROUND', 'citation': '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': '9554651', 'type': 'BACKGROUND', 'citation': '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': '17179262', 'type': 'BACKGROUND', 'citation': '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': '17114984', 'type': 'BACKGROUND', 'citation': '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': '16901611', 'type': 'BACKGROUND', 'citation': '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': '16061732', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Participants undergoing Off-CABG will be randomized 1:1 to one of the following groups:\n\n* treatment with CirQlator TM Intrathoracic Pressure Regulator (ITPR)\n* 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).\n\nSpecifically, 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.\n\nWe 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.', 'detailedDescription': '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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients presenting for elective off-pump CABG age 18 years of age and older informed consent has been obtained\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT01205620', 'briefTitle': 'IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery', 'orgStudyIdInfo': {'id': '15084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ITPR', 'description': "• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).", 'interventionNames': ['Device: ITPR']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'No intervention will be performed in this control group', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'ITPR', 'type': 'DEVICE', 'description': "• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).", 'armGroupLabels': ['ITPR']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention will be performed in the control group', 'armGroupLabels': ['No intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Julie L Huffmyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UVA Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Julie L. Huffmeyer, MD', 'oldOrganization': 'UVA anesthehesiology'}}}}