Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.
This study is enrolling participants by invitation only.
Sponsor:
Transonic Systems Inc.
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01103895
First received: April 13, 2010
Last updated: June 4, 2012
Last verified: June 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 13, 2010 | ||||||||
| Last Updated Date | June 4, 2012 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cardiac output after cardiopulmonary bypass [ Time Frame: Less than 10 minutes ] [ Designated as safety issue: No ] Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01103895 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Cardiac output before cardiopulmonary bypass [ Time Frame: Less than 10 minutes ] [ Designated as safety issue: No ] Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output. |
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| 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 | Measurement of Cardiac Output Before and After Cardiopulmonary Bypass. | ||||||||
| Official Title ICMJE | Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass | ||||||||
| Brief Summary | Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard." |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Cardiac Output | ||||||||
| Intervention ICMJE | Device: HCE101 Cardiopulmonary Support Monitor
Measurement of cardiac output before and after cardiopulmonary bypass in adult patients. |
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| Study Arm (s) | Experimental: Adult CO before and after CPB
Measurement of cardiac output before and after cardiopulmonary bypass using an ultrasound dilution technique. Comparison with thermodilution cardiac output before and after cardiopulmonary bypass.
Intervention: Device: HCE101 Cardiopulmonary Support Monitor |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01103895 | ||||||||
| Other Study ID Numbers ICMJE | TSI-C-HCE101-4A-H, 2R44HL082022-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Transonic Systems Inc. | ||||||||
| Study Sponsor ICMJE | Transonic Systems Inc. | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Transonic Systems Inc. | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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