Investigation of Sedation Depth Via BIS Monitoring in ICU After Cardiac Surgery

NCT07350109 | Recruiting

• 1 other identifier: 1368
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Sedation After Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of time spent in deep sedation

  BIS \<50

  immediately after extubation or up to 48 hours of ICU sedation - whichever comes first

Secondary Outcomes (7)

• Duration of mechanical ventilation

  immediately after extubation

• Incidence of pulmonary infection

  immediately after ICU discharge

• Incidence of ICU delirium

  immediately after extubation

• Time average of vasopressor dose

  immediately after extubation or after 48 hours of invasive ventilation

• ICU and hospital LOS

  immediately after hospital discharge

Study Arms (1)

study group

adult patients who have undergone cardiac surgery expected to require invasive mechanical ventilation and continuous sedation for more than six hours postoperatively

Eligibility Criteria

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

Study Population

patients admitted to the ICU following cardiac surgery. These patients are expected to require invasive mechanical ventilation and continuous sedation for more than 6 hours postoperatively.

You may qualify if:

• Age ≥ 18 years.
• Undergoing cardiac surgery with subsequent admission to the ICU
• expected duration of invasive mechanical ventilation \> 6 hours postop.
• Written informed consent obtained from the patient or legal representative (if the patient is not capable of consent).

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.
• Patients in whom short-term survival is deemed unlikely due to clinical course

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

Medical University Graz

Graz, Styria, 8010, Austria

RECRUITING

Klinikum Wels

Wels, Upper Austria, 4600, Austria

RECRUITING

Central Study Contacts

Selina Sartori, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 20, 2026
• Study Start: November 22, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 26, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-01

Locations

AU (2)