Cardiac Surgical Procedures (Postoperative Population), Critical Illness, Delirium - Postoperative, Pneumonia, Ventilator-Associated, Postoperative Complications (Cardiopulmonary)
Conditions
Brief summary
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
OTHERDevice-guided sedation
in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation
OTHERstandard sedation practice
sedation due to standard clinical practice, using sedation scores such as RASS-Score
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-masked. Treating staff (care providers) are unblinded; outcome assessors (and data analysts) are blinded to group assignment. Participants are not specifically masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time-averaged Propofol dose during continuous ICU sedation | immediately after discontinuation of propofol | mean Propofol infusion rate in mg/kg/h averaged over the continuous sedation period until discontinuation of Propofol (or switch to other sedative, return to OR or death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of invasive mechanical ventilation | immediately after extubation | Duration of invasive mechanical ventilation in hours |
| Duration of continuous sedation | immediately after extubation | Duration of continuous sedation in hours |
| Incidence of pulmonary infections | at ICU discharge | pneumonie, tracheobronchial infections |
| Proportion of time spent in deep sedation | immediately after discontinuation of Propofol | Proportion of time during sedation with BIS values \<50 |
| BIS values over time | immediately after discontinuation of Propofol | Bispectral Index (BIS) is a monitoring system providing values from 0 to 100, reflecting brain activity with 100 being fully awake an 0 indicating no brain activity (isoelectric EEG). A range of 40-60 typicallysignifies adequate general anesthesia during surgery. |
| Length of ICU stay | at ICU discharge | Length of ICU stay in days |
| Total hospital length of stay | at hospital discharge | Total hospital length of stay in days |
| In-hospital mortality | at ICU discharge | — |
| Incidence of ICU delirium | immediately after extubation | Incidence of ICU delirium (assessed using CAM-ICU or ICDSC) |
| Time-averaged catecholamine dose administered (in mcg/kg/min) during continuous sedation | immediately after discontinuation of Propofol | — |
Contacts
CONTACTSelina Sartori, MD
Outcome results
None listed