BIS in ICU Interventional Study

NCT07350122 | Not Yet Recruiting

• 1 other identifier: 1579
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• time-averaged Propofol dose during continuous ICU sedation

  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)

  immediately after discontinuation of propofol

Secondary Outcomes (10)

• Duration of invasive mechanical ventilation

  immediately after extubation

• Duration of continuous sedation

  immediately after extubation

• Incidence of pulmonary infections

  at ICU discharge

• Proportion of time spent in deep sedation

  immediately after discontinuation of Propofol

• BIS values over time

  immediately after discontinuation of Propofol

Study Arms (2)

BIS-Guided Sedation

EXPERIMENTAL

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.

Other: Device-guided sedation

Standard Sedation with Blinded BIS

ACTIVE COMPARATOR

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).

Other: standard sedation practice

Interventions

Device-guided sedation OTHER

in addition to standard clinical sedation management, BIS monitoring will be applied in order to avoid unintended deep sedation

BIS-Guided Sedation

standard sedation practice OTHER

sedation due to standard clinical practice, using sedation scores such as RASS-Score

Standard Sedation with Blinded BIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

MeSH Terms

Conditions

Critical Illness; Postoperative Complications; Emergence Delirium; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease

Central Study Contacts

Selina Sartori, MD

CONTACT

+43 664 1652783; selina.sartori@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-masked. Treating staff (care providers) are unblinded; outcome assessors (and data analysts) are blinded to group assignment. Participants are not specifically masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 12 months after publication of the primary results and for a period of 5 years thereafter
• Access Criteria: Available to qualified researchers with a methodologically sound proposal. Requests will be reviewed by the Principal investigator. Approved requestors must: Sign a data use agreement (DUA) prohibiting re-identification and onward sharing. Obtain local IRB/ethics approval (or exemption) for the proposed analysis. Use data solely for the approved purpose and comply with GDPR and applicable data protection laws. Mode of access: Controlled access via the University Hospital Graz secure institutional repository. Instructions for requesting access will be provided via the study contact email: \[selina.sartori@medunigraz.at\]