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

An Explorative Prospective Non-interventional Study on Sedation Depth in Postoperative Cardiac Surgery Patients Using Blinded BIS Monitoring

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07350109

Acronym

BISICU

Enrollment

Registered

2026-01-20

Start date

2025-11-22

Completion date

2026-03-26

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation After Cardiac Surgery

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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).

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of time spent in deep sedation	immediately after extubation or up to 48 hours of ICU sedation - whichever comes first	BIS \<50

Secondary

Measure	Time frame	Description
Duration of mechanical ventilation	immediately after extubation	—
Incidence of pulmonary infection	immediately after ICU discharge	any kind of pulmonary infection, including tracheobronchitis, pneumonia
Incidence of ICU delirium	immediately after extubation	assessed using CAM-ICU or ICDSC
Time average of vasopressor dose	immediately after extubation or after 48 hours of invasive ventilation	Time average of Noradrenaline dose
ICU and hospital LOS	immediately after hospital discharge	in days
in hospital mortality	immediately after hospital discharge	—
Incidence of BIS suppression events	immediately after extubation or after 48 hours of invasive ventilation	episodes where the suppression ratio exceeds 10%, indicating potential over-sedation or EEG suppression

Countries

Austria

Outcome results