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

This study has been completed.

Sponsor:

Information provided by:

University of Virginia

ClinicalTrials.gov Identifier:

NCT01205594

First received: September 17, 2010

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2010

Last Updated Date

August 9, 2011

Start Date ^ICMJE

May 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

hemodynamic variables [ Time Frame: baseline & 2 minutes post device activation ] [ Designated as safety issue: No ]

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

left ventricular performance [ Time Frame: baseline &2 minutes after activation of the device ] [ Designated as safety issue: No ]

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Experimental: ITPR device

the ITPR will be inserted in the anesthesia circuit and activated to provide -10 mmHg ETP.

Intervention: Device: ITPR

Publications *

* 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

Enrollment ^ICMJE

Completion Date

Not Provided

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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