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Main
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Note: This record shows only 22 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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24 October 2016 |
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Main ID: |
NCT02932371 |
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Date of registration:
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11/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the ECOM™ Monitor for Continuous and Non-invasive Measure of the Cardiac Output in Cardiac Surgery Patients
EVALECOM2 |
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Scientific title:
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Date of first enrolment:
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January 2013 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02932371 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients over18 years
- Needed cardiac surgery,
- Needed a monitoring by transesophageal ultrasound ,
- Benefiting from a social security scheme
- Having given their written consent.
Exclusion Criteria:
- Pregnant or breast-feeding women,
- Allergy to polyvinylchloride (PVC),
- The patients for whom a difficulty of ventilation with a mask or intubation is
envisaged,
- Contraindication to transesophageal ultrasound, a steady cardiac arrhythmia, a flight
or an aortic shrinkage.
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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Cardiac Surgery
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Intervention(s)
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Device: ECOM™.
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Device: Trans-esophageal echography
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Primary Outcome(s)
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Cardiac output
[Time Frame: 4 hours]
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Secondary ID(s)
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2012/11
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2012-A00398-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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