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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01205594 |
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Date of registration:
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17/09/2010 |
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Primary sponsor: |
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Public title:
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IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery
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Scientific title:
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IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01205594 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Countries of recruitment
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United States
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Contacts
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Name:
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Edward C Nemergut, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia Anesthesiology |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Device: ITPR
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Primary Outcome(s)
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hemodynamic variables
[Time Frame: baseline & 2 minutes post device activation]
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Secondary Outcome(s)
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left ventricular performance
[Time Frame: baseline &2 minutes after activation of the device]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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