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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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17 November 2015 |
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Main ID: |
NCT02593448 |
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Date of registration:
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27/10/2015 |
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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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Influence of Cardiopulmonary Bypass, and Sevoflurane or Propofol Anesthesia, on Tissue Oxygen Saturation.
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Scientific title:
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Influence of Cardiopulmonary Bypass and Sevoflurane or Propofol Anesthesia on Tissue Oxygen Saturation of Thenar Muscle in Adults. |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02593448 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Alexandra Biedrzycka, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Gdansk, Department of Cardiac Anesthesiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult
- scheduled for elective, open-heart cardiac surgical operation with use of
cardiopulmonary bypass.
- signed written consent
Exclusion Criteria:
- surgeon's intention to use the radial artery for arterial bypass
- symptoms of peripheral atherosclerosis
- paresis of a limb
- autoimmune disease
- other factors that could potentially affect blood flow in the upper extremities
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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NIR Spectroscopy
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Intervention(s)
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Procedure: General anaesthesia with sevoflurane use
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Procedure: NIRS during VOT
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Procedure: General anaesthesia with propofol use
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Primary Outcome(s)
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Changes in thenar muscle saturation
[Time Frame: During VOT performed at 6 timepoints]
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Secondary ID(s)
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NKBN/34/2012
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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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