BIS in ICU Interventional Study

Medical University of Graz

Status: Not yet enrolling

Conditions: Delirium - Postoperative; Pneumonia, Ventilator-Associated; Postoperative Complications (Cardiopulmonary); Critical Illness; Cardiac Surgical Procedures (Postoperative Population)

Treatments: Other: standard sedation practice; Other: Device-guided sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT07350122

1579

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

144 participants in 2 patient groups

BIS-Guided Sedation

Experimental group

Description:

Continuous BIS monitoring is visible to the care team. Sedation is titrated using BIS values plus routine clinical assessment, with instruction to avoid sustained BIS \< 50.

Treatment:

Other: Device-guided sedation

Standard Sedation with Blinded BIS

Active Comparator group

Description:

Sedation is managed per standard clinical practice using validated clinical scales (e.g., RASS). BIS monitoring is performed but hidden from caregivers (not used for clinical decisions).

Treatment:

Other: standard sedation practice