BIS in ICU Interventional Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device-guided sedation, standard sedation practice.
- Who it may be relevant to
- Registry conditions: Cardiac Surgical Procedures (Postoperative Population), Critical Illness, Postoperative Complications (Cardiopulmonary), Delirium - Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of BIS-Guided Sedation on Clinical Outcomes in Postoperative Cardiac Surgery ICU Patients: A Prospective, Randomized Controlled Trial
Overview
This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery. BIS is a non-invasive, EEG-based monitor that shows a number from 0-100 to reflect level of consciousness. Researchers will compare BIS-guided sedation to standard sedation guided by clinical scales (such as the Richmond Agitation-Sedation Scale, RASS). About 144 participants will be randomly assigned (1:1) to one of two groups at two hospitals in Austria (Medical University of Graz and Klinikum Wels-Grieskirchen). In the BIS group, clinicians will use BIS values and standard care to titrate sedation and will aim to avoid sustained BIS values below 50. In the control group, sedation will follow standard practices using clinical scales; BIS will be recorded but hidden from caregivers. The trial is open-label for treating staff; outcome assessors and data analysts will be blinded. Participants will be in the study during their ICU sedation and mechanical ventilation period (typically more than 6 hours), with follow-up through ICU and hospital discharge. The primary outcome is the time-averaged dose of propofol (mg/kg/h) given during continuous ICU sedation until weaning (up to 72 hours). Secondary outcomes include duration of ventilation and sedation, depth of sedation measures, sedative and catecholamine doses, pulmonary infections (including ventilator-associated pneumonia), ICU and hospital length of stay, delirium, and in-hospital mortality. Risks are minimal and may include mild skin irritation from forehead electrodes. Possible benefits include improved sedation management; benefits are not guaranteed. Taking part is voluntary.
Interventions
- Other Device-guided sedation
in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation - Other standard sedation practice
sedation due to standard clinical practice, using sedation scores such as RASS-Score
Primary outcome measures
- time-averaged Propofol dose during continuous ICU sedation [Time frame: immediately after discontinuation of propofol]
Secondary outcome measures (10)
- Duration of invasive mechanical ventilation [Time frame: immediately after extubation]
- Duration of continuous sedation [Time frame: immediately after extubation]
- Incidence of pulmonary infections [Time frame: at ICU discharge]
- Proportion of time spent in deep sedation [Time frame: immediately after discontinuation of Propofol]
- BIS values over time [Time frame: immediately after discontinuation of Propofol]
- Length of ICU stay [Time frame: at ICU discharge]
- Total hospital length of stay [Time frame: at hospital discharge]
- In-hospital mortality [Time frame: at ICU discharge]
- Incidence of ICU delirium [Time frame: immediately after extubation]
- Time-averaged catecholamine dose administered (in mcg/kg/min) during continuous sedation [Time frame: immediately after discontinuation of Propofol]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Undergoing cardiac surgery with subsequent admission to the intensive care unit (e.g., valve surgery, coronary artery bypass grafting, aortic surgery)
- Planned or expected duration of invasive mechanical ventilation > 6 hours postoperatively
- Requirement for continuous sedation during ICU stay
Exclusion criteria
- Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy).
- Acute neurological events in the perioperative period (e.g., stroke, intracranial hemorrhage).
- Severe hepatic dysfunction (Child-Pugh Class C).
- Participation in another interventional study potentially affecting sedation or cognitive outcomes.
- Pregnancy or lactation.
- Do-not-intubate (DNI)/Do-not-resuscitate (DNR) orders or documented limitation of therapy.
- Patients in whom short-term survival is deemed unlikely due to the clinical course.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07350122 · 1579