Actively Recruiting
Investigation of Sedation Depth Via BIS Monitoring in ICU After Cardiac Surgery
Led by Medical University of Graz · Updated on 2026-03-27
50
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a non-interventional, observational research project focused on monitoring sedation levels in patients who have undergone cardiac surgery. It uses a tool called Bispectral Index (BIS), which measures brain activity to assess sedation depth. The goal is to understand how often patients experience deep sedation (BIS \<50) during the first 48 hours in the ICU and to explore its impact on clinical outcomes like ventilation duration, ICU stay length, and complications such as infections or delirium. The study is conducted at two hospitals in Austria and involves patients who require mechanical ventilation and continuous sedation for more than six hours after surgery. BIS data will be collected continuously, but the readings will be blinded to the clinical team, meaning they will not influence patient care. Sedation will be managed using standard clinical practices. The findings aim to improve sedation management in ICUs.
CONDITIONS
Official Title
Investigation of Sedation Depth Via BIS Monitoring in ICU After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- Undergoing cardiac surgery with ICU admission
- Expected invasive mechanical ventilation for more than 6 hours after surgery
- Written informed consent from patient or legal representative
You will not qualify if you...
- Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy)
- Acute neurological events around surgery (e.g., stroke, intracranial hemorrhage)
- Severe liver dysfunction (Child-Pugh Class C)
- Participation in another interventional study affecting sedation or cognition
- Pregnancy or breastfeeding
- Patients unlikely to survive short-term due to clinical condition
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Medical University Graz
Graz, Styria, Austria, 8010
Actively Recruiting
2
Klinikum Wels
Wels, Upper Austria, Austria, 4600
Actively Recruiting
Research Team
S
Selina Sartori, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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