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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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12 December 2020 |
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Main ID: |
NCT02532530 |
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Date of registration:
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19/08/2015 |
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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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Peri-operative Monitoring of Cerebral Oxygenation and the Onset of Delirium in Patients Undergoing Cardiac Surgery
ICARUS |
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Scientific title:
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Peri-operative Monitoring of Regional Cerebral Oxygen Saturation and Onset of Delirium in Cardiac Surgery Patients |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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103 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02532530 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Frank Jans, prof. dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ziekenhuis Oost-Limburg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients (age = 70 years) undergoing elective on-pump cardiac surgery (i.e.
valve replacement with or without Coronary artery bypass graft surgery (CABG))
- Surgery has to be performed under normothermic conditions
- Ability to perform the confusion assessment method for the intensive care unit
(CAM-ICU)
- Patients willing to provide written informed consent
Exclusion Criteria:
- Age < 70 years
- Off-pump cardiac surgery
- Surgery performed under hypothermic conditions
- Duration before extubation > 36 hours
- Patients with insufficient knowledge of the Dutch language
- Patients using antipsychotics
- Patients with a known history of alcohol abuse (consuming two or more units a day)
Age minimum:
70 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Delirium
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Intervention(s)
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Device: Near-Infrared Spectroscopy (NIRS)
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Primary Outcome(s)
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Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative)
[Time Frame: pre, intra and postoperative measurement of cerebral oxygen saturation (three days)]
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Secondary Outcome(s)
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Cerebral autoregulation performance using a COX index
[Time Frame: Intraoperative measurement]
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Secondary ID(s)
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ZOLDELIRIUM1
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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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