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Completed

NCT Number: NCT07350109

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

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.

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Key information

Conditions

Sedation After Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz, Graz, Styria, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of time spent in deep sedation

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

    BIS <50

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: immediately after extubation

  2. Incidence of pulmonary infection

    Time frame: immediately after ICU discharge

    any kind of pulmonary infection, including tracheobronchitis, pneumonia

  3. Incidence of ICU delirium

    Time frame: immediately after extubation

    assessed using CAM-ICU or ICDSC

  4. Time average of vasopressor dose

    Time frame: immediately after extubation or after 48 hours of invasive ventilation

    Time average of Noradrenaline dose

  5. ICU and hospital LOS

    Time frame: immediately after hospital discharge

    in days

  6. in hospital mortality

    Time frame: immediately after hospital discharge

  7. Incidence of BIS suppression events

    Time frame: immediately after extubation or after 48 hours of invasive ventilation

    episodes where the suppression ratio exceeds 10%, indicating potential over-sedation or EEG suppression

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: BISICU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.